Back to resultsBentracimab (PB2452) in Ticagrelor-treated Patients With Uncontrolled Major or Life-Threatening Bleeding or Requiring Urgent Surgery or Invasive Procedure (REVERSE-IT)
Primary Purpose
Hemorrhage, Urgent Surgery, Invasive Procedure
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bentracimab (PB2452) Infusion
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhage focused on measuring Bleeding
Eligibility Criteria
Inclusion Criteria:
Patients will be eligible for inclusion into the study if they meet all of the following criteria:
- Male or female >18 years of age with documented or verbal informed consent. Emergency consent may be obtained where permitted by local regulations and institutional approval.
- History or documentation of ticagrelor intake within the prior 3 days
- Patients described below who require urgent reversal of the antiplatelet effects of ticagrelor:
Patients with uncontrolled major or life-threatening bleeding, requiring urgent reversal of the antiplatelet effects of ticagrelor. It is expected that enrolled patients would have characteristics similar to those described below:
- Potentially life-threatening bleeding with signs or symptoms of hemodynamic compromise, e.g., systolic blood pressure < 90 mm Hg and signs or symptoms of low cardiac output not otherwise explained
- Bleeding in a critical organ or closed space, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular bleed with compartment syndrome
- Visible, uncontrolled bleeding associated with a corrected hemoglobin level < 8.0 g/dL, a fall in hemoglobin level of ≥ 2.0 g/dL (1.24 mmol/L) from a known baseline, or requirement for transfusion of 2 or more units of packed red blood cells (PRBC)
Patients requiring urgent surgery or invasive procedure when it is not medically advisable either to proceed urgently with impaired hemostasis or to delay the urgent procedure for 3 or more days due to the high risk of bleeding. These patients may typically be in any of the following clinical situations:
- Requires urgent surgery or invasive procedure known to be associated with a risk of significant bleeding (such as cardiac surgery, neurosurgery, or major orthopedic surgery)
- Requires urgent surgery or invasive procedure that may have an adverse procedural outcome if hemostasis is impaired (such as neurological, spinal, ophthalmological, urological, or orthopedic surgery)
- At risk of experiencing life-threatening events, such as, shock, myocardial infarction, or stroke, if significant intraoperative or postoperative bleeding occurs (such as in elderly patients or patients with underlying cardiac or pulmonary disease who have limited cardiopulmonary reserve)
Exclusion Criteria:
- Known sensitivity or contraindication to PB2452 or any of its excipients
- Patients in whom ticagrelor reversal is not considered urgent, e.g., patients with stable or non-acute conditions who have low hemoglobin due to chronic, low-grade gastrointestinal bleeding or who have stable, remote, or asymptomatic intracranial hemorrhage
- Patients expected to be clinically unsalvageable, such as, patients with end-stage cancer or patients with overwhelming sepsis
- Any condition which, in the opinion of the investigator, would make it unsafe or unsuitable for the patients to participate in this study. This includes assessment of likelihood to cooperate with study follow-up visits and procedures. Known pregnancy may be exclusionary in some regions or countries as directed by national health authorities and/or local Institutional Review Boards/Ethics Committees
- Known use of clopidogrel, prasugrel or ticlopidine within 5 days of study drug administration; known use of antiplatelet GPIIb/IIIa inhibitors, or cangrelor within 5 half-lives of expected study drug administration; or known use of warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban within 5 half-lives of expected study drug administration
- Known recent use (< 5 day) of vitamin K, prothrombin complex concentrate, recombinant factor VIIa, idarucizumab, or andexanet-alfa (coagulation factor Xa (recombinant), inactivated-zhzo)
Sites / Locations
- Providence St. Jude Medical Center
- MedStar Health Research InstituteRecruiting
- Baptist Medical Center
- University of Florida Health, JacksonvilleRecruiting
- Mayo ClinicRecruiting
- Intercoastal Medical Group, Inc.Recruiting
- University of Iowa Hospitals and ClinicsRecruiting
- University of KentuckyRecruiting
- Ochsner LSU Health ShreveportRecruiting
- Sinai Hospital of Baltimore
- White Oak Medical Center
- Henry Ford HospitalRecruiting
- Beaumont Hospital, Royal Oak
- North Kansas City HospitalRecruiting
- Cox Medical CentersRecruiting
- East Carolina University
- Duke Heart Center at Southeastern HealthRecruiting
- Sanford Medical Center FargoRecruiting
- Ascension St. John Clinical Research InstituteRecruiting
- Allegheny General Hospital
- Crozer Chester Medical Center
- Rhode Island HospitalRecruiting
- Stern Cardiovascular Foundation, Inc.Recruiting
- Johnson City Medical CenterRecruiting
- University of Tennessee Medical CenterRecruiting
- JPS Health NetworkRecruiting
- Klinische Abteilung für Innere Medizin 3 Universitätsklinikum St. PöltenRecruiting
- Klinik Ottakring 3rd Med Dept, Cardiology and Intensive Care MedicineRecruiting
- Algemeen Stedelijk Ziekenhuis (ASZ) Study Center CardiologyRecruiting
- Ziekenhuis Oost-Limburg Study Center Intensive CareRecruiting
- AZ Sint-Jan Brugge-Oostende AV Poli CardiologieRecruiting
- University Hospital Antwerp Cardiology Department - Clinical TrialsRecruiting
- Jessa Hospital Hartcentrum Hasselt Research CenterRecruiting
- University Hospital Leuven, Universitair Ziekenhuis Leuven Dienst Bloedings- en VaatziektenRecruiting
- Foothills Medical CentreRecruiting
- University of Alberta HospitalRecruiting
- St. Paul's HospitalRecruiting
- St. Boniface HospitalRecruiting
- Saint John Regional HospitalRecruiting
- William Osler Health System - Brampton Civic Hospital
- Hamilton Health Sciences CentreRecruiting
- Kingston Health Sciences CentreRecruiting
- York PCI Group, Inc.Recruiting
- Oakville Trafalgar Memorial HospitalRecruiting
- University of Ottawa Heart InstituteRecruiting
- St. Michael's Hospital, Unity Health TorontoRecruiting
- Toronto General HospitalRecruiting
- Montreal Heart InstituteRecruiting
- McGill University Health CenterRecruiting
- Centre intégré universitaire de santé et de services sociaux du Nord-de-l'lle-de-Montréal (CIUSSS NIM)/Hopital du Sacré-Coeur-de-MontréalRecruiting
- Institut universitaire de cardiologie et de pneumologie de Quebec - Universite LavalRecruiting
- Beijing Anzhen Hospital, Capital Medical UniversityRecruiting
- China-Japan Friendship HospitalRecruiting
- Peking University First Hospital
- Beijing Chaoyang Hospital, Capital Medical University
- Peking University People's HospitalRecruiting
- Peking University Third HospitalRecruiting
- Lanzhou University Second Hospital
- The First Affiliated Hospital of Zhengzhou University
- The Central Hospital of WuhanRecruiting
- Huai'an First People's HospitalRecruiting
- The First Hospital of Jilin UniversityRecruiting
- Medidata
- First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
- Tianjin Medical University General HospitalRecruiting
- Tianjin Chest HospitalRecruiting
- Sir Run Run Shaw Hospital, Zhejiang University School of MedicineRecruiting
- MedidataRecruiting
- Zhejiang Provincial People's HospitalRecruiting
- CHU de Lille Service USIC, Institut Coeur PoumonRecruiting
- Assistance Publique-Hopitaux de Paris (AP-HP) Pitie-Salpetriere HospitalRecruiting
- Bichat Hospital, Service de CardiologieRecruiting
- CHRU de Tours - Hopital Trousseau Service de Cardiologie-USCI 2 eme etageRecruiting
- ASST Monza - Ospedale San GerardoRecruiting
- Azienda Ospedaliero-Universitaria di Parma CardiologiaRecruiting
- Istituto Clinico Humanitas UO Cardiologia Clinica e InterventisticaRecruiting
- Medisch Spectrum TwenteRecruiting
- St Antonius HospitalRecruiting
- Complejo Hospitalario Universitario A CorunaRecruiting
- Hospital Universitario Vall d'HebronRecruiting
- Hospital Universitario 12 de Octubre, Residencia generalRecruiting
- Hospital Clinico San Carlos - Instituto Cardiovascular (ICV)
- Hospital Universitario Vírgen de la VictoriaRecruiting
- Hospital Universitario Virgen MacarenaRecruiting
- Skane University Hospital, Department of CardiologyRecruiting
- Region Uppsala, Akademiska Hospital Cardio and Pulmonary Medicine and Clinical PhysiologyRecruiting
- Universitatsspital Basel Department of CardiologyRecruiting
- Cardiocentro TicinoRecruiting
- East and North Hertfordshire, NHS Trust, Lister Cardiac Research Office, Cardiology Green Zone, Lister HospitalRecruiting
- Sheffield Teaching Hospitals, NHS Foundation Trust, Northern General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bentracimab (PB2452) Infusion - Open Label Active Drug
Arm Description
Bentracimab (PB2452) 18 g Intravenous Infusion over a 16 hour duration. Patients with uncontrolled major or life-threatening bleeding. Bentracimab (PB2452) 18 g Intravenous Infusion over a 16 hour duration. For patients in need of urgent surgery or invasive procedure.
Outcomes
Primary Outcome Measures
Reversal - Platelet Reactivity Units (PRU)
Minimum % inhibition of PRU within 4 hours of the initiation of study drug as assessed by VerifyNow™ PRUTest™ platelet function assay
Hemostasis - Uncontrolled major of life-threatening bleeding - Achievement
Achievement of effective (graded as good or excellent) hemostasis after initiation of PB2452 infusion will be assessed using prespecified criteria for effective hemostasis for visible and non-visible major bleeding [Scale (from best to worst) measured as: Excellent, Good, Poor/None]
Hemostasis - Urgent surgery or invasive procedure - Achievement
Achievement of effective hemostasis following initiation of PB2452 infusion will be centrally adjudicated using prespecified criteria for effective hemostasis derived from the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) clinical bleeding scale [GUSTO scale (from best to worst): Effective (no bleeding, mild bleeding or moderate bleeding) or Not effective (severe bleeding)]
Secondary Outcome Measures
Minimum % inhibition of Platelet Reactivity Index (PRI) (VASP)
Minimum % inhibition of PRI assessed by VASP within 4 hours after the initiation of study drug
Maximum reversal of PRU assessed by VerifyNow™ PRUTest™
Maximum reversal of PRU assessed by VerifyNow™ PRUTest™ within 4 hours after the initiation of study drug.
Maximum reversal of PRI assessed by VASP
Maximum reversal of PRI assessed by VASP within 4 hours after the initiation of study drug.
Proportion of subjects achieving reversal of platelet inhibition of ticagrelor using PRU and PRI - 60%
Proportion of subjects achieving 60% reversal of platelet inhibition by ticagrelor using PRU and PRI at any time point during the treatment period
Proportion of subjects achieving reversal of platelet inhibition of ticagrelor using PRU and PRI - 80%
Proportion of subjects achieving 80% reversal of platelet inhibition by ticagrelor using PRU and PRI at any time point during the treatment period
Proportion of subjects achieving reversal of platelet inhibition of ticagrelor using PRU and PRI - 100%
Proportion of subjects achieving 100% reversal of platelet inhibition by ticagrelor using PRU and PRI at any time point during the treatment period
Duration of at least 60% reversal by PRU and PRI
Duration of at least 80% reversal by PRU and PRI
Duration of at least 100% reversal by PRU and PRI
Intracranial hemorrhage (ICH) Patients Only: Proportion of ICH patients with modified Rankin Scale (mRS) score of 0-3 versus 4-6 at 90 days on a scale of 0-6 (better to worse)
ICH Patients Only: Absolute and percent change form baseline in modified Rankin Scale (mRS) score at 90 days in ICH patients on a scale of 0-6 (better to worse)
ICH Patients Only: EQ-5D 5L Quality of Life Questionnaire index at 90 days and change from baseline in ICH patients on a scale of 0-100 (best to worst)
Full Information
NCT ID
NCT04286438
First Posted
February 21, 2020
Last Updated
October 31, 2022
Sponsor
PhaseBio Pharmaceuticals Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04286438
Brief Title
Bentracimab (PB2452) in Ticagrelor-treated Patients With Uncontrolled Major or Life-Threatening Bleeding or Requiring Urgent Surgery or Invasive Procedure
Acronym
REVERSE-IT
Official Title
A Phase 3, Multicenter, Open-Label, Single-Arm Study of Bentracimab (PB2452) in Ticagrelor-Treated Patients With Uncontrolled Major or Life-Threatening Bleeding or Requiring Urgent Surgery or Invasive Procedure (REVERSE-IT Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PhaseBio Pharmaceuticals Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a multi-center, open-label, prospective single-arm study of reversal of the antiplatelet effects of ticagrelor with bentracimab (PB2452) in patients who present with uncontrolled major or life-threatening bleeding or who require urgent surgery or invasive procedure.
At least 200 patients will be enrolled from approximately 200 centers in North America, Europe, and Asia-Pacific regions, including mainland China. Patients with reported use of ticagrelor within the prior 3 days who require urgent ticagrelor reversal will be eligible for enrollment. These populations will be enrolled based on separate inclusion criteria.
Detailed Description
The study will consist of a Screening/Pre-treatment period, an on-site assignment to study treatment and administration, a Follow-up visit on (Day 3+1 and Day 7±1), a Final Follow-up visit (Day 35±3) and a Follow-up visit for intracranial hemorrhage (ICH) only patients (Day 90±10). Infusion of PB2452 will be initiated on Day 1 and will continue for approximately 16 hours for a total of 18 g.
On Day 1, subjects who meet all the inclusion criteria and none of the exclusion criteria will receive an intravenous (IV) infusion comprised of an initial IV bolus of 6 grams (g) infused over 10 minutes for rapid reversal, followed immediately by a 6g IV loading infusion over 4 hours and then a 6 g IV maintenance infusion over 12 hours. This bentracimab (PB2452) regimen is expected to provide immediate reversal of the antiplatelet effects of ticagrelor within 5 minutes of the initiation of infusion that is sustained for 20-24 hours.
In subjects with potential drug interaction from recent concomitant use of moderate or strong CYP3A inhibitors with ticagrelor, an alternative regimen may be used comprising administration of 36 g over an active treatment period of 24 hours and 10 min. (This alternative regimen will be an initial 12 g bolus infusion over 10 minutes, followed immediately by a loading infusion of 12 g over 6 hours which will then be followed by a maintenance regimen of 12 g infused over 18 hours for a total infusion of 36 grams over 24 hours and 10 minutes).
In patients presenting with intracranial hemorrhage (ICH), brain imaging within 2 hours of initiation of study drug and at least one follow-up brain imaging performed 12-24 hours post completion of PB2452 will be required to support adjudication of hemostasis.
All subjects may be discharged from the clinical site between Days 3 and 7 inclusive and will return for a Follow-up visit on Day 7, if already discharged, and on Day 35 (± 3 days). All ICH patients must complete End of Study (EOS) Day 35±3 (Visit 5). ICH patients that agree to participate in the ICH-only-90-day-follow-up visit will have an additional visit on Day 90±10 (Visit 6).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage, Urgent Surgery, Invasive Procedure
Keywords
Bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bentracimab (PB2452) Infusion - Open Label Active Drug
Arm Type
Experimental
Arm Description
Bentracimab (PB2452) 18 g Intravenous Infusion over a 16 hour duration. Patients with uncontrolled major or life-threatening bleeding.
Bentracimab (PB2452) 18 g Intravenous Infusion over a 16 hour duration. For patients in need of urgent surgery or invasive procedure.
Intervention Type
Drug
Intervention Name(s)
Bentracimab (PB2452) Infusion
Intervention Description
Bentracimab (PB2452) 18 g Intravenous Infusion over a 16 hour duration.
In subjects with potential drug interaction from recent concomitant use of moderate or strong CYP3A inhibitors with ticagrelor, the active treatment period may be 24 hours and 10 min if receiving the 36g infusion.
In patients presenting with intracranial hemorrhage (ICH), brain imaging within 2 hours of initiation of study drug and at least one follow-up brain imaging performed 12-24 hours post completion of PB2452.
Primary Outcome Measure Information:
Title
Reversal - Platelet Reactivity Units (PRU)
Description
Minimum % inhibition of PRU within 4 hours of the initiation of study drug as assessed by VerifyNow™ PRUTest™ platelet function assay
Time Frame
4 hours post-initiation of infusion
Title
Hemostasis - Uncontrolled major of life-threatening bleeding - Achievement
Description
Achievement of effective (graded as good or excellent) hemostasis after initiation of PB2452 infusion will be assessed using prespecified criteria for effective hemostasis for visible and non-visible major bleeding [Scale (from best to worst) measured as: Excellent, Good, Poor/None]
Time Frame
4 hours post-initiation of infusion
Title
Hemostasis - Urgent surgery or invasive procedure - Achievement
Description
Achievement of effective hemostasis following initiation of PB2452 infusion will be centrally adjudicated using prespecified criteria for effective hemostasis derived from the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) clinical bleeding scale [GUSTO scale (from best to worst): Effective (no bleeding, mild bleeding or moderate bleeding) or Not effective (severe bleeding)]
Time Frame
4 hours post-initiation of infusion
Secondary Outcome Measure Information:
Title
Minimum % inhibition of Platelet Reactivity Index (PRI) (VASP)
Description
Minimum % inhibition of PRI assessed by VASP within 4 hours after the initiation of study drug
Time Frame
4 hours post-initiation of infusion
Title
Maximum reversal of PRU assessed by VerifyNow™ PRUTest™
Description
Maximum reversal of PRU assessed by VerifyNow™ PRUTest™ within 4 hours after the initiation of study drug.
Time Frame
4 hours post-initiation of infusion
Title
Maximum reversal of PRI assessed by VASP
Description
Maximum reversal of PRI assessed by VASP within 4 hours after the initiation of study drug.
Time Frame
4 hours post-initiation of infusion
Title
Proportion of subjects achieving reversal of platelet inhibition of ticagrelor using PRU and PRI - 60%
Description
Proportion of subjects achieving 60% reversal of platelet inhibition by ticagrelor using PRU and PRI at any time point during the treatment period
Time Frame
Any time point between infusion initiation and Day 3 (Pre-dose, 5-10 minutes, 30+5 minutes, 1+0.25 hours, 4+0.25 hours, 12+0.5 hours, 24+1 hours, and Day 3)
Title
Proportion of subjects achieving reversal of platelet inhibition of ticagrelor using PRU and PRI - 80%
Description
Proportion of subjects achieving 80% reversal of platelet inhibition by ticagrelor using PRU and PRI at any time point during the treatment period
Time Frame
Any time point between infusion initiation and Day 3 (Pre-dose, 5-10 minutes, 30+5 minutes, 1+0.25 hours, 4+0.25 hours, 12+0.5 hours, 24+1 hours, and Day 3)
Title
Proportion of subjects achieving reversal of platelet inhibition of ticagrelor using PRU and PRI - 100%
Description
Proportion of subjects achieving 100% reversal of platelet inhibition by ticagrelor using PRU and PRI at any time point during the treatment period
Time Frame
Any time point between infusion initiation and Day 3 (Pre-dose, 5-10 minutes, 30+5 minutes, 1+0.25 hours, 4+0.25 hours, 12+0.5 hours, 24+1 hours, and Day 3)
Title
Duration of at least 60% reversal by PRU and PRI
Time Frame
Any time point between infusion initiation and Day 3 (Pre-dose, 5-10 minutes, 30+5 minutes, 1+0.25 hours, 4+0.25 hours, 12+0.5 hours, 24+1 hours, and Day 3)
Title
Duration of at least 80% reversal by PRU and PRI
Time Frame
Any time point between infusion initiation and Day 3 (Pre-dose, 5-10 minutes, 30+5 minutes, 1+0.25 hours, 4+0.25 hours, 12+0.5 hours, 24+1 hours, and Day 3)
Title
Duration of at least 100% reversal by PRU and PRI
Time Frame
Any time point between infusion initiation and Day 3 (Pre-dose, 5-10 minutes, 30+5 minutes, 1+0.25 hours, 4+0.25 hours, 12+0.5 hours, 24+1 hours, and Day 3)
Title
Intracranial hemorrhage (ICH) Patients Only: Proportion of ICH patients with modified Rankin Scale (mRS) score of 0-3 versus 4-6 at 90 days on a scale of 0-6 (better to worse)
Time Frame
[Time Frame: Pre-dose, Day 35 and Day 90]
Title
ICH Patients Only: Absolute and percent change form baseline in modified Rankin Scale (mRS) score at 90 days in ICH patients on a scale of 0-6 (better to worse)
Time Frame
[Time Frame: Pre-dose, Day 35 and Day 90]
Title
ICH Patients Only: EQ-5D 5L Quality of Life Questionnaire index at 90 days and change from baseline in ICH patients on a scale of 0-100 (best to worst)
Time Frame
[Time Frame: Pre-dose, Day 35 and Day 90]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients will be eligible for inclusion into the study if they meet all of the following criteria:
Male or female >18 years of age with documented or verbal informed consent. Emergency consent may be obtained where permitted by local regulations and institutional approval.
History or documentation of ticagrelor intake within the prior 3 days
Patients described below who require urgent reversal of the antiplatelet effects of ticagrelor:
Patients with uncontrolled major or life-threatening bleeding, requiring urgent reversal of the antiplatelet effects of ticagrelor. It is expected that enrolled patients would have characteristics similar to those described below:
Potentially life-threatening bleeding with signs or symptoms of hemodynamic compromise, e.g., systolic blood pressure < 90 mm Hg and signs or symptoms of low cardiac output not otherwise explained
Bleeding in a critical organ or closed space, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular bleed with compartment syndrome
Visible, uncontrolled bleeding associated with a corrected hemoglobin level < 8.0 g/dL, a fall in hemoglobin level of ≥ 2.0 g/dL (1.24 mmol/L) from a known baseline, or requirement for transfusion of 2 or more units of packed red blood cells (PRBC)
Patients requiring urgent surgery or invasive procedure when it is not medically advisable either to proceed urgently with impaired hemostasis or to delay the urgent procedure for 3 or more days due to the high risk of bleeding. These patients may typically be in any of the following clinical situations:
Requires urgent surgery or invasive procedure known to be associated with a risk of significant bleeding (such as cardiac surgery, neurosurgery, or major orthopedic surgery)
Requires urgent surgery or invasive procedure that may have an adverse procedural outcome if hemostasis is impaired (such as neurological, spinal, ophthalmological, urological, or orthopedic surgery)
At risk of experiencing life-threatening events, such as, shock, myocardial infarction, or stroke, if significant intraoperative or postoperative bleeding occurs (such as in elderly patients or patients with underlying cardiac or pulmonary disease who have limited cardiopulmonary reserve)
Exclusion Criteria:
Known sensitivity or contraindication to PB2452 or any of its excipients
Patients in whom ticagrelor reversal is not considered urgent, e.g., patients with stable or non-acute conditions who have low hemoglobin due to chronic, low-grade gastrointestinal bleeding or who have stable, remote, or asymptomatic intracranial hemorrhage
Patients expected to be clinically unsalvageable, such as, patients with end-stage cancer or patients with overwhelming sepsis
Any condition which, in the opinion of the investigator, would make it unsafe or unsuitable for the patients to participate in this study. This includes assessment of likelihood to cooperate with study follow-up visits and procedures. Known pregnancy may be exclusionary in some regions or countries as directed by national health authorities and/or local Institutional Review Boards/Ethics Committees
Known use of clopidogrel, prasugrel or ticlopidine within 5 days of study drug administration; known use of antiplatelet GPIIb/IIIa inhibitors, or cangrelor within 5 half-lives of expected study drug administration; or known use of warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban within 5 half-lives of expected study drug administration
Known recent use (< 5 day) of vitamin K, prothrombin complex concentrate, recombinant factor VIIa, idarucizumab, or andexanet-alfa (coagulation factor Xa (recombinant), inactivated-zhzo)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials
Phone
888-521-2805
Email
Clinicaltrials@phasebio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepak Bhatt, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital, Division of Cardiovascular Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Providence St. Jude Medical Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Withdrawn
Facility Name
MedStar Health Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terry Moriarty, MSN, RN
Phone
202-877-3657
Email
Theresa.m.moriarty@medstar.net
First Name & Middle Initial & Last Name & Degree
Munish Goyal, MD
Facility Name
Baptist Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Florida Health, Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Franchi, MD
Phone
904-244-2060
Email
francesco.franchi@jax.ufl.edu
First Name & Middle Initial & Last Name & Degree
Francesco Franchi, MD
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosita Almira
Phone
904-953-7533
Email
almira.rosita@mayo.edu
First Name & Middle Initial & Last Name & Degree
Lauren K Ng, MD
Facility Name
Intercoastal Medical Group, Inc.
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanette Wilson
Phone
941-404-4390
Email
jewilson@intercoastalmedical.com
First Name & Middle Initial & Last Name & Degree
Mauricio Concha, MD, MHS
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cathy Fairfield
Phone
319-384-8335
Email
Catherine-fairfield@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Dana King, MD
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Isaacs
Phone
859-323-4738
Email
Jennifer.isaacs@uky.edu
First Name & Middle Initial & Last Name & Degree
John Kotter, MD
Facility Name
Ochsner LSU Health Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela P. Cornelius, MD, FACEP
Phone
318-626-2325
Email
acorne@lsuhsc.edu
First Name & Middle Initial & Last Name & Degree
Angela P. Cornelius, MD, FACEP
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Gesheff, MS
Phone
410-601-9467
Email
mgesheff@lifebridgehealth.org
First Name & Middle Initial & Last Name & Degree
Paul Gurbel, MD
Facility Name
White Oak Medical Center
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20904
Country
United States
Individual Site Status
Withdrawn
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romualdo Ancog
Phone
313-916-1011
Email
Rancog1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Jeffrey Johnson, MD
Facility Name
Beaumont Hospital, Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Withdrawn
Facility Name
North Kansas City Hospital
City
North Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dianne Kruger-Sargent
Phone
816-691-5373
Email
dianne.kruger-sargent@nkch.org
First Name & Middle Initial & Last Name & Degree
Zafir Hawa, MD
Facility Name
Cox Medical Centers
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Ratcliff, MS, CCRC
Phone
417-631-0214
Email
Jessica.Ratcliff@coxhealth.com
First Name & Middle Initial & Last Name & Degree
Timothy Woods, MD
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Withdrawn
Facility Name
Duke Heart Center at Southeastern Health
City
Lumberton
State/Province
North Carolina
ZIP/Postal Code
28358
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Herzog, MD
Phone
910-272-7241
Email
William.herzog@duke.edu
First Name & Middle Initial & Last Name & Degree
William Herzog, MD
Facility Name
Sanford Medical Center Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leah Hustad
Phone
701-417-2002
Email
leah.hustad@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Mentor Ahmeti, MD
Facility Name
Ascension St. John Clinical Research Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacie Merritt, MSN, RN-BC
Phone
918-744-3426
Email
Stacie.merritt@ascension.org
First Name & Middle Initial & Last Name & Degree
Michael Charles, MD
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Hebda
Phone
412-491-1384
Email
Ctgov@ahn.org
First Name & Middle Initial & Last Name & Degree
John O'Neill, MD
Facility Name
Crozer Chester Medical Center
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Individual Site Status
Withdrawn
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Bahamon
Phone
401-444-2902
Email
ibahamon@lifespan.org
First Name & Middle Initial & Last Name & Degree
Gregory Jay, MD, PhD
Facility Name
Stern Cardiovascular Foundation, Inc.
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Rehak
Phone
901-226-1820
Email
Mary.rehak@bmhcc.org
First Name & Middle Initial & Last Name & Degree
Basil Paulus, MD
Facility Name
Johnson City Medical Center
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlie Mays
Phone
423-431-5654
Email
Charles.Mays@balladhealth.org
First Name & Middle Initial & Last Name & Degree
J. Bracken Burns, Jr., DO
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Daley, MD
Phone
865-251-4658
Email
bdaley@utmck.edu
First Name & Middle Initial & Last Name & Degree
Brian Daley, MD
Facility Name
JPS Health Network
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Max Masuda
Phone
817-702-6746
Email
MMasuda@jpshealth.org
First Name & Middle Initial & Last Name & Degree
Angela Cornelius, MD, FACEP
Facility Name
Klinische Abteilung für Innere Medizin 3 Universitätsklinikum St. Pölten
City
Sankt Pölten
ZIP/Postal Code
3100
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Weiss, MD
Phone
(+43) 6607735687
Email
ordination@doktorweiss.at
First Name & Middle Initial & Last Name & Degree
Thomas Weiss, MD
Facility Name
Klinik Ottakring 3rd Med Dept, Cardiology and Intensive Care Medicine
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kurt Huber, MD
Phone
(+43) 1 49 150 2301
Email
kurt.huber@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Kurt Huber, MD
Facility Name
Algemeen Stedelijk Ziekenhuis (ASZ) Study Center Cardiology
City
Aalst
State/Province
East Flanders
ZIP/Postal Code
9300
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Vanduynhoven, MD
Phone
+ 32 053 76 67 30
Email
philippe.vanduynhoven@asz.be
First Name & Middle Initial & Last Name & Degree
Philippe Vanduynhoven, MD
Facility Name
Ziekenhuis Oost-Limburg Study Center Intensive Care
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sam Van Boxstael, MD
Phone
+ 32 89 327100
Email
sam.vanboxstael@zol.be
First Name & Middle Initial & Last Name & Degree
Sam Van Boxstael, MD
Facility Name
AZ Sint-Jan Brugge-Oostende AV Poli Cardiologie
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Buysschaert, MD
Phone
(+32) 50 45 38 96
Email
ian.buysschaert@azsintjan.be
First Name & Middle Initial & Last Name & Degree
Ian Buysschaert, MD
Facility Name
University Hospital Antwerp Cardiology Department - Clinical Trials
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Claeys, MD
Phone
(+32) 38 213000
Email
marc.claeys@uantwerpen.be
First Name & Middle Initial & Last Name & Degree
Marc Claeys, MD
Facility Name
Jessa Hospital Hartcentrum Hasselt Research Center
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal Vranckx, MD
Phone
(+32) 11 309393
Email
pascal.vranckx@jessazh.be
First Name & Middle Initial & Last Name & Degree
Pascal Vranckx, MD
Facility Name
University Hospital Leuven, Universitair Ziekenhuis Leuven Dienst Bloedings- en Vaatziekten
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Vandenbriele, MD
Phone
(+32) 163 41 463
Email
christophe.vandenbriele@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Christophe Vandenbriele, MD
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Manasterski
Phone
403-210-8548
Email
Linda.manasterski@ahs.ca
First Name & Middle Initial & Last Name & Degree
Alexander J Gregory, MD, FRCPC
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin H Bainey, MD
Phone
780-407-2176
Email
Kevin.bainey@ahs.ca
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z1Y6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Donohoe
Phone
604-781-5585
Email
kdonohue@providencehealth.bc.ca
First Name & Middle Initial & Last Name & Degree
Krishnan Ramanathan, MD
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashish Shah, MD
Phone
204-258-1322
Email
Ashah5@sbgh.mb.ca
First Name & Middle Initial & Last Name & Degree
Ashish Shah, MD
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Brown, MD
Phone
506-648-7614
Email
cdbrown@nbnet.nb.ca
First Name & Middle Initial & Last Name & Degree
Craig Brown, MD
Facility Name
William Osler Health System - Brampton Civic Hospital
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joy Anne Gatmaitan
Phone
905-494-2120
Ext
58666
Email
JoyAnne.Gatmaitan@williamoslerhs.ca
First Name & Middle Initial & Last Name & Degree
Masud Khandaker, MD, PhD
Facility Name
Hamilton Health Sciences Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shamir Mehta, MD
Phone
905-527-4322
Ext
40631
Email
smehta@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Shamir Mehta, MD
Facility Name
Kingston Health Sciences Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Phelan
Phone
613-549-6666
Ext
3403
Email
Rachel.Phelan@kingstonhsc.ca
First Name & Middle Initial & Last Name & Degree
Tarit Saha, MBBS, FRCPC
Facility Name
York PCI Group, Inc.
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Warren Cantor, MD
Phone
905-235-5966
Email
cantorw@rogers.com
First Name & Middle Initial & Last Name & Degree
Warren Cantor, MD
Facility Name
Oakville Trafalgar Memorial Hospital
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6M 0L8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adic Perez, MD
Phone
(905)845-2571
Ext
4154
Email
adperez@haltonhealthcare.com
First Name & Middle Initial & Last Name & Degree
Michael Heffernan, MD
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Crowe
Phone
613-696-7000
Ext
10656
Email
SCrowe@ottawaheart.ca
First Name & Middle Initial & Last Name & Degree
Marc Ruel, MD
Facility Name
St. Michael's Hospital, Unity Health Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Mazer, MD, FRCPC
Phone
416-864-5825
Email
david.mazer@unityhealth.to
First Name & Middle Initial & Last Name & Degree
David Mazer, MD, FRCPC
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terrence Yau, MD
Phone
416-340-4074
Email
Terry.yau@uhn.ca
First Name & Middle Initial & Last Name & Degree
Terrence Yau, MD
Facility Name
Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Francois Tanguay, MD
Phone
514-376-3330
Email
jean-francois.tanguay@icm-mhi.org
First Name & Middle Initial & Last Name & Degree
Jean-Francois Tanguay, MD
Facility Name
McGill University Health Center
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Lachapelle, MD
Phone
514-934-1934
Ext
36873
Email
Kevin.lachapelle@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Kevin Lachapelle, MD
Facility Name
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'lle-de-Montréal (CIUSSS NIM)/Hopital du Sacré-Coeur-de-Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugues Jeanmart, MD
Phone
514-338-2222
Ext
2050
Email
h.jeanmart@me.com
First Name & Middle Initial & Last Name & Degree
Hugues Jeanmart, MD
Facility Name
Institut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Voisine, MD
Phone
418-656-4717
Email
pierre.voisine@fmed.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Pierre Voisine, MD
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaoping Nie, MD
Phone
+8613701186772
Email
spnie@126.com
First Name & Middle Initial & Last Name & Degree
Shaoping Nie, MD
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yihong Sun, MD
Phone
+8613811224720
Email
yihongsun72@163.com
First Name & Middle Initial & Last Name & Degree
Yihong Sun, MD
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianping Li, MD
Phone
+8613521531013
Email
13521531013@163.com
First Name & Middle Initial & Last Name & Degree
Jianping Li, MD
Facility Name
Beijing Chaoyang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100043
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mulei Chen, MD
Phone
+8613911995971
Email
chen_1758@126.com
First Name & Middle Initial & Last Name & Degree
Mulei Chen, MD
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jihong Zhu, MBBS
Phone
+8601088326666
Email
goodfriendcc@126.com
First Name & Middle Initial & Last Name & Degree
Jihong Zhu, MBBS
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100083
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiangli Han, MD
Phone
+8613910801907
Email
dr_hanjiangli@126.com
First Name & Middle Initial & Last Name & Degree
Jiangli Han, MD
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Lin, MBBS
Phone
+8613519403007
Email
linxin1145@163.com
First Name & Middle Initial & Last Name & Degree
Xin Lin, MBBS
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changju Zhu, MD
Phone
+8613939062157
Email
zhuchangju98@163.com
First Name & Middle Initial & Last Name & Degree
Changju Zhu, MD
Facility Name
The Central Hospital of Wuhan
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manhua Chen, MBBS
Phone
+8613986105198
Email
chenmh@aliyun.com
First Name & Middle Initial & Last Name & Degree
Manhua Chen, MBBS
Facility Name
Huai'an First People's Hospital
City
Huai'an
State/Province
Jiangsu
ZIP/Postal Code
223300
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiwen Zhang, MD
Phone
+8618752301110
Email
zhangxiwen303@163.com
First Name & Middle Initial & Last Name & Degree
Xiwen Zhang, MD
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yushi Wang, MD
Phone
+8618643199605
Email
yushi-doc2014@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yushi Wang, MD
Facility Name
Medidata
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lishan Yang, MBBS
Phone
+8613995216188
Email
nyfyyls@126.com
First Name & Middle Initial & Last Name & Degree
Lishan Yang, MBBS
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zuyi Yuan, MD
Phone
+862985323819
Email
zuyiyuan@mail.xjtu.edu.cn
First Name & Middle Initial & Last Name & Degree
Zuyi Yuan, MD
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanfen Chai, MBBS
Phone
+8613821582860
Email
chaiyanfen2012@126.com
First Name & Middle Initial & Last Name & Degree
Yanfen Chai, MBBS
Facility Name
Tianjin Chest Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300222
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongliang Cong, MD
Phone
+8613702102871
Email
hongliangcong@163.com
First Name & Middle Initial & Last Name & Degree
Hongliang Cong, MD
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guosheng Fu, MD
Phone
+8613605800707
Email
fugs@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Guosheng Fu, MD
Facility Name
Medidata
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianan Wang, MD
Phone
+8613805786328
Email
wja@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Jianan Wang, MD
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihong Wang, MD
Phone
+8613666690598
Email
wanglhnew@126.com
First Name & Middle Initial & Last Name & Degree
Lihong Wang, MD
Facility Name
CHU de Lille Service USIC, Institut Coeur Poumon
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles Lemesle, MD
Phone
(+33) 3 20 44 53 30
Email
gilles.lemesle@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
Gilles Lemesle, MD
Facility Name
Assistance Publique-Hopitaux de Paris (AP-HP) Pitie-Salpetriere Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles Montalescot, MD
Phone
(+33) 1 42 16 30 06
Email
gilles.montalescot@aphp.fr
First Name & Middle Initial & Last Name & Degree
Gilles Montalescot, MD
Facility Name
Bichat Hospital, Service de Cardiologie
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Steg, MD
Phone
(+33) 140258669
Email
gabriel.steg@aphp.fr
First Name & Middle Initial & Last Name & Degree
Philippe Steg, MD
Facility Name
CHRU de Tours - Hopital Trousseau Service de Cardiologie-USCI 2 eme etage
City
Tours
ZIP/Postal Code
37170
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis Angoulvant, MD
Phone
(+33) 247479054
Email
d.angoulvant@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Denis Angoulvant
Facility Name
ASST Monza - Ospedale San Gerardo
City
Monza
ZIP/Postal Code
20090
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Federico Magni, MD
Phone
(+39) 392 334 337
Email
f.magni@asst-monza.it
First Name & Middle Initial & Last Name & Degree
Federico Magni, MD
Facility Name
Azienda Ospedaliero-Universitaria di Parma Cardiologia
City
Parma
ZIP/Postal Code
43126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Ardissino, MD
Phone
(+39) 0521702070
Email
dardissino@ao.pr.it
First Name & Middle Initial & Last Name & Degree
Diego Ardissino, MD
Facility Name
Istituto Clinico Humanitas UO Cardiologia Clinica e Interventistica
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernhard Reimers, MD
Phone
(+39) 282244635
Email
bernhard.reimers@humanitas.it
First Name & Middle Initial & Last Name & Degree
Bernhard Reimers, MD
Facility Name
Medisch Spectrum Twente
City
Enschede
State/Province
Overijssel
ZIP/Postal Code
7512 KZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clemens von Birgelen, MD
Phone
(+31) 534872105
Email
cre@mst.nl
First Name & Middle Initial & Last Name & Degree
Clemens von Birgelen, MD
Facility Name
St Antonius Hospital
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jurrien M Ten Berg, MD
Phone
(+31) 883203000
Email
jurtenberg@gmail.com
First Name & Middle Initial & Last Name & Degree
Jurrien M Ten Berg, MD
Facility Name
Complejo Hospitalario Universitario A Coruna
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Manuel Vazquez Rodriguez, MD
Phone
(+34) 981178342
Email
jose.manuel.vazquez.rodriguez@sergas.es
First Name & Middle Initial & Last Name & Degree
Jose Manuel Vazquez Rodriguez, MD
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Barrabes, MD
Phone
(+34) 932746000
Ext
6396
Email
jabarrabes@vhebron.net
First Name & Middle Initial & Last Name & Degree
Jose Barrabes, MD
Facility Name
Hospital Universitario 12 de Octubre, Residencia general
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hector Jose Bueno Zamora, MD
Phone
(+34) 913908519
Email
hector.bueno@cnic.es
First Name & Middle Initial & Last Name & Degree
Hector Jose Bueno Zamora, MD
Facility Name
Hospital Clinico San Carlos - Instituto Cardiovascular (ICV)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital Universitario Vírgen de la Victoria
City
Málaga
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Temboury, MD
Phone
(+34) 649461625
Email
francisco.temboury.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
Francisco Temboury, MD
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Jesus Hidalgo Urbano, MD
Phone
(+34) 629987772
Email
rjhidalur@yahoo.es
First Name & Middle Initial & Last Name & Degree
Rafael Jesus Hidalgo Urbano, MD
Facility Name
Skane University Hospital, Department of Cardiology
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Erlinge, MD
Phone
(+46) 733746165
Email
david.erlinge@gmail.com
First Name & Middle Initial & Last Name & Degree
David Erlinge, MD
Facility Name
Region Uppsala, Akademiska Hospital Cardio and Pulmonary Medicine and Clinical Physiology
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Sevcik, MD
Phone
(+46) 720 341 372
Email
robert.sevcik@akademiska.se
First Name & Middle Initial & Last Name & Degree
Robert Sevcik, MD
Facility Name
Universitatsspital Basel Department of Cardiology
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Mueller, MD
Phone
(+41) 61 3286549
Email
christian.mueller@usb.ch
First Name & Middle Initial & Last Name & Degree
Christian Mueller, MD
Facility Name
Cardiocentro Ticino
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Valgimigli
Phone
(+41) 918053347
Email
marco.valgimigli@cardiocentro.org
First Name & Middle Initial & Last Name & Degree
Marco Valgimigli, MD
Facility Name
East and North Hertfordshire, NHS Trust, Lister Cardiac Research Office, Cardiology Green Zone, Lister Hospital
City
Stevenage
State/Province
Hertfordshire
ZIP/Postal Code
SG1 4AB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Gorog, MD
Phone
+44 (0) 1438 284379
Email
d.gorog@imperial.ac.uk
First Name & Middle Initial & Last Name & Degree
Diana Gorog, MD
Facility Name
Sheffield Teaching Hospitals, NHS Foundation Trust, Northern General Hospital
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Storey, MD
Phone
(+44) 1142266159
Email
r.f.storey@sheffield.ac.uk
First Name & Middle Initial & Last Name & Degree
Robert Storey, MD
12. IPD Sharing Statement
Learn more about this trial
Bentracimab (PB2452) in Ticagrelor-treated Patients With Uncontrolled Major or Life-Threatening Bleeding or Requiring Urgent Surgery or Invasive Procedure
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