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Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH (BRAVO 2/3)

Primary Purpose

Severe Aortic Stenosis, Transcatheter Aortic Valve Replacement, Aortic Valve Replacement

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bivalirudin
Unfractionated Heparin
Sponsored by
The Medicines Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Aortic Stenosis focused on measuring Transcatheter aortic valve replacement, Aortic valve replacement, Severe aortic stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females, ≥18 years of age
  • High risk (Euroscore ≥18, or considered inoperable) for surgical aortic valve replacement
  • Undergoing TAVR via transfemoral arterial access
  • Provide written informed consent before initiation of any study related procedures

Exclusion Criteria:

  • Any known contra-indication to the use of bivalirudin (except presence of severe renal impairment [glomerular filtration rate (GFR) <30 milliliters (mL)/minute] since these participants will be included in the trial or UFH
  • Refusal to receive blood transfusion
  • Mechanical valve (any location) or mitral bioprosthetic valve
  • Extensive calcification of the common femoral artery, or minimal luminal diameter <6.5 millimeters (mm)
  • Use of elective surgical cut-down for transfemoral access
  • Concurrent performance of percutaneous coronary intervention with TAVR
  • International normalized ratio (INR) ≥2 on the day of TAVR procedure or known history of bleeding diathesis
  • History of hemorrhagic stroke, intracranial hemorrhage, intracerebral mass or aneurysm, or arteriovenous malformation
  • Severe left ventricular dysfunction (left ventricular ejection fraction <15%)
  • Severe aortic regurgitation or mitral regurgitation (4+)
  • Hemodynamic instability (for example, requiring inotropic or intra-aortic balloon pump support) within 2 hours of the procedure
  • Dialysis dependent
  • Administration of thrombolytics, glycoprotein IIb/IIIa inhibitors, or warfarin in the 3 days prior to the procedure
  • Acute myocardial infarction, major surgery, or any therapeutic cardiac procedure (other than balloon aortic valvuloplasty) within 30 days
  • Percutaneous coronary intervention within 30 days
  • Upper gastrointestinal or genitourinary bleed within 30 days
  • Stroke or transient ischemic attack within 30 days
  • Any surgery or biopsy within 2 weeks

  • Administration of:

    • UFH within 30 minutes of the procedure
    • Enoxaparin within 8 hours of the procedure
    • Fondaparinux or other low-molecular-weight heparins (LMWHs) within 24 hours of the procedure
    • Dabigatran, rivaroxaban, or other oral anti-Xa or antithrombin agent within 48 hours of the procedure
    • Thrombolytics, glycoprotein IIb/IIIa inhibitor, or warfarin within 72 hours of the procedure
  • Absolute contraindications or allergy that cannot be pre-medicated to iodinated contrast
  • Contraindications or allergy to aspirin or clopidogrel
  • Known or suspected pregnant women or nursing mothers. Women of child-bearing potential will be asked if they are pregnant and will be tested for pregnancy
  • Previous enrollment in this study
  • Treatment with other investigational drugs or devices within the 30 days preceding enrollment or planned use of other investigational drugs or devices before the primary endpoint of this study has been reached

Sites / Locations

  • Montreal Heart Institute
  • St. Paul´s Hospital Providence Health Care
  • Clinique Pasteur, Unité de Cardiologie Interventionnelle
  • CHU de Toulouse
  • CHU Jean Minjoz, Service de Cardiologie
  • Centre Hospitalier de Lyon
  • Department of Cardiology, CHRU Lille
  • Institut Hospitalier Jacques Cartier
  • Service de Cardiologie, Centre Hospitalo-Universitaire, Hôpital Charles-Nicolle
  • University Heart Centre, Clinic of Inner Medicine 1 Cardiology
  • Universitätsklinikum Bonn
  • Klinikum links der Weser Bremen
  • Elisabeth-Krankenhaus Essen
  • Freiburg University
  • Asklepios St. Georg Hamburg
  • Universitätsklinikum Hamburg-Eppendorf
  • Medizinische Hochschule Hannover
  • Universität Leipzig - Herzzentrum GmbH
  • Universitätsmedizin der Johannes Gutenberg-Universitat Mainz
  • LMU Munich, Klinikum der Universität München
  • Deutsches Herzzentrum München
  • Helios Heart Center Siegburg
  • Ferraroto Hospital, University of Catania
  • Ospedale San Raffaele U.O. Cardiologia Interventistica
  • Azienda Ospedaliero-Universitaria Pisana
  • Azienda Ospedaliera San Camillo-Forlanini
  • Policlinico Umberto I, Università La Sapienza
  • St. Antonius Ziekenhuis
  • University Medical Center Utrecht
  • Cardiology University Hospital Basel
  • Universitätsklinik Bern
  • The Royal Sussex County Hospital
  • Hammersmith Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bivalirudin

Unfractionated heparin (UFH)

Arm Description

Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.

The dose of UFH adhered to the standard institutional practice. An activated clotting time (ACT) target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.

Outcomes

Primary Outcome Measures

Major Bleeding (BARC ≥3b) at 48 Hours or Before Hospital Discharge
Major bleeding (Bleeding Academic Research Consortium [BARC] type ≥3b) was defined as follows: Bleeds that were evident clinically, or by laboratory or imaging results, which resulted in surgical intervention or administration of IV vasoactive drugs; overt bleeds with a hemoglobin drop of at least 5 grams per deciliter (g/dL); and bleeding that caused cardiac tamponade. BARC 3c includes intracranial or intraocular bleeds that compromised vision. BARC type 4 (Coronary Artery Bypass Grafting [CABG]-related bleeding) includes perioperative intracranial bleeding within 48 hours, bleeds that result in reoperation following closure of sternotomy for the purpose of controlling bleeding, bleeds that result in treatment with transfusion of ≥5 units of whole blood or packed red blood cells within a 48 hour period; and chest tube output ≥2 liters (L) within a 24-hour period. BARC type 5, fatal bleeding, describes bleeds that directly result in death with no other cause.
Net Adverse Clinical Events (NACE) at up to 30 Days
The net adverse cardiac events (NACE) at 30 days is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, myocardial infarction (MI), and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint.

Secondary Outcome Measures

NACE at 48 Hours or Before Hospital Discharge
NACE at 48 hours or before hospital discharge is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, MI, and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint.
Major Adverse Cardiac Events (MACE) Including Death, Non-fatal MI, and Stroke
The percentage of participants reporting a MACE overall and the individual components of MACE (including death, non-fatal MI, and stroke) are presented.
Major Bleeding According to Additional Scales (VARC, TIMI, GUSTO, ACUITY/HORIZONS)
Percentage of participants with major bleeding according to the following scales: Valve Academic Research Consortium (VARC)=life threatening, disabling bleeding, or major bleeding Thrombolysis in Myocardial Infarction (TIMI)=major bleeding Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)=severe or moderate Acute Catheterization and Urgent Intervention Triage StrategY (ACUITY)/Harmonizing Outcomes with RevasculariZatiON and Stents (HORIZONS)=major bleeding
Transient Ischemic Attack
The percentage of participants reporting transient ischemic attack is presented.
Acute Kidney Injury
The percentage of participants reporting acute kidney injury is presented.
Major Vascular Complications
The percentage of participants reporting a major vascular complications as defined by VARC is presented.
Acquired Thrombocytopenia
The percentage of participants reporting acquired thrombocytopenia is presented.
New Onset Atrial Fibrillation/Flutter
The percentage of participants reporting new onset atrial fibrillation/flutter is presented.
Timing Effect on Bleeding Event Rate up to 48 Hours or Hospital Discharge
The effect of timing on bleeding event rates (the percentage of participants with an incidence of major bleeding) is presented.
Bleeding BARC 3a, BARC Types 1 or 2, and TIMI Minor
The percentage of participants with moderate bleeding as defined by BARC 3a and minor bleeding as defined as BARC type 1 and 2 and TIMI minor is presented.

Full Information

First Posted
July 24, 2012
Last Updated
March 9, 2017
Sponsor
The Medicines Company
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1. Study Identification

Unique Protocol Identification Number
NCT01651780
Brief Title
Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH
Acronym
BRAVO 2/3
Official Title
Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3 (BRAVO 2/3)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Medicines Company

4. Oversight

Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR). The primary hypothesis of BRAVO 3 was that bivalirudin would reduce major bleeding compared with heparin in TAVR procedures. Results for all participants enrolled into the randomized trial (BRAVO 3) are presented.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Aortic Stenosis, Transcatheter Aortic Valve Replacement, Aortic Valve Replacement
Keywords
Transcatheter aortic valve replacement, Aortic valve replacement, Severe aortic stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
803 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bivalirudin
Arm Type
Experimental
Arm Description
Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
Arm Title
Unfractionated heparin (UFH)
Arm Type
Active Comparator
Arm Description
The dose of UFH adhered to the standard institutional practice. An activated clotting time (ACT) target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
Intervention Type
Drug
Intervention Name(s)
Bivalirudin
Other Intervention Name(s)
AngioMAX, Angiox
Intervention Description
Bivalirudin is an anticoagulant that binds directly to thrombin in a bivalent and reversible fashion.
Intervention Type
Drug
Intervention Name(s)
Unfractionated Heparin
Other Intervention Name(s)
Heparin
Intervention Description
Unfractionated heparin is an anticoagulant.
Primary Outcome Measure Information:
Title
Major Bleeding (BARC ≥3b) at 48 Hours or Before Hospital Discharge
Description
Major bleeding (Bleeding Academic Research Consortium [BARC] type ≥3b) was defined as follows: Bleeds that were evident clinically, or by laboratory or imaging results, which resulted in surgical intervention or administration of IV vasoactive drugs; overt bleeds with a hemoglobin drop of at least 5 grams per deciliter (g/dL); and bleeding that caused cardiac tamponade. BARC 3c includes intracranial or intraocular bleeds that compromised vision. BARC type 4 (Coronary Artery Bypass Grafting [CABG]-related bleeding) includes perioperative intracranial bleeding within 48 hours, bleeds that result in reoperation following closure of sternotomy for the purpose of controlling bleeding, bleeds that result in treatment with transfusion of ≥5 units of whole blood or packed red blood cells within a 48 hour period; and chest tube output ≥2 liters (L) within a 24-hour period. BARC type 5, fatal bleeding, describes bleeds that directly result in death with no other cause.
Time Frame
at 48 hours or discharge, whichever occurs first
Title
Net Adverse Clinical Events (NACE) at up to 30 Days
Description
The net adverse cardiac events (NACE) at 30 days is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, myocardial infarction (MI), and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint.
Time Frame
up to 30 days after procedure
Secondary Outcome Measure Information:
Title
NACE at 48 Hours or Before Hospital Discharge
Description
NACE at 48 hours or before hospital discharge is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, MI, and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint.
Time Frame
at 48 hours or before hospital discharge, whichever occurred earlier
Title
Major Adverse Cardiac Events (MACE) Including Death, Non-fatal MI, and Stroke
Description
The percentage of participants reporting a MACE overall and the individual components of MACE (including death, non-fatal MI, and stroke) are presented.
Time Frame
at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
Title
Major Bleeding According to Additional Scales (VARC, TIMI, GUSTO, ACUITY/HORIZONS)
Description
Percentage of participants with major bleeding according to the following scales: Valve Academic Research Consortium (VARC)=life threatening, disabling bleeding, or major bleeding Thrombolysis in Myocardial Infarction (TIMI)=major bleeding Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)=severe or moderate Acute Catheterization and Urgent Intervention Triage StrategY (ACUITY)/Harmonizing Outcomes with RevasculariZatiON and Stents (HORIZONS)=major bleeding
Time Frame
at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up
Title
Transient Ischemic Attack
Description
The percentage of participants reporting transient ischemic attack is presented.
Time Frame
at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
Title
Acute Kidney Injury
Description
The percentage of participants reporting acute kidney injury is presented.
Time Frame
at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up
Title
Major Vascular Complications
Description
The percentage of participants reporting a major vascular complications as defined by VARC is presented.
Time Frame
at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
Title
Acquired Thrombocytopenia
Description
The percentage of participants reporting acquired thrombocytopenia is presented.
Time Frame
at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
Title
New Onset Atrial Fibrillation/Flutter
Description
The percentage of participants reporting new onset atrial fibrillation/flutter is presented.
Time Frame
at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
Title
Timing Effect on Bleeding Event Rate up to 48 Hours or Hospital Discharge
Description
The effect of timing on bleeding event rates (the percentage of participants with an incidence of major bleeding) is presented.
Time Frame
Up to 48 hours after procedure or at hospital discharge (but also includes any subsequent hospitalizations)
Title
Bleeding BARC 3a, BARC Types 1 or 2, and TIMI Minor
Description
The percentage of participants with moderate bleeding as defined by BARC 3a and minor bleeding as defined as BARC type 1 and 2 and TIMI minor is presented.
Time Frame
at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females, ≥18 years of age High risk (Euroscore ≥18, or considered inoperable) for surgical aortic valve replacement Undergoing TAVR via transfemoral arterial access Provide written informed consent before initiation of any study related procedures Exclusion Criteria: Any known contra-indication to the use of bivalirudin (except presence of severe renal impairment [glomerular filtration rate (GFR) <30 milliliters (mL)/minute] since these participants will be included in the trial or UFH Refusal to receive blood transfusion Mechanical valve (any location) or mitral bioprosthetic valve Extensive calcification of the common femoral artery, or minimal luminal diameter <6.5 millimeters (mm) Use of elective surgical cut-down for transfemoral access Concurrent performance of percutaneous coronary intervention with TAVR International normalized ratio (INR) ≥2 on the day of TAVR procedure or known history of bleeding diathesis History of hemorrhagic stroke, intracranial hemorrhage, intracerebral mass or aneurysm, or arteriovenous malformation Severe left ventricular dysfunction (left ventricular ejection fraction <15%) Severe aortic regurgitation or mitral regurgitation (4+) Hemodynamic instability (for example, requiring inotropic or intra-aortic balloon pump support) within 2 hours of the procedure Dialysis dependent Administration of thrombolytics, glycoprotein IIb/IIIa inhibitors, or warfarin in the 3 days prior to the procedure Acute myocardial infarction, major surgery, or any therapeutic cardiac procedure (other than balloon aortic valvuloplasty) within 30 days Percutaneous coronary intervention within 30 days Upper gastrointestinal or genitourinary bleed within 30 days Stroke or transient ischemic attack within 30 days Any surgery or biopsy within 2 weeks Administration of: UFH within 30 minutes of the procedure Enoxaparin within 8 hours of the procedure Fondaparinux or other low-molecular-weight heparins (LMWHs) within 24 hours of the procedure Dabigatran, rivaroxaban, or other oral anti-Xa or antithrombin agent within 48 hours of the procedure Thrombolytics, glycoprotein IIb/IIIa inhibitor, or warfarin within 72 hours of the procedure Absolute contraindications or allergy that cannot be pre-medicated to iodinated contrast Contraindications or allergy to aspirin or clopidogrel Known or suspected pregnant women or nursing mothers. Women of child-bearing potential will be asked if they are pregnant and will be tested for pregnancy Previous enrollment in this study Treatment with other investigational drugs or devices within the 30 days preceding enrollment or planned use of other investigational drugs or devices before the primary endpoint of this study has been reached
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Lefevre, MD
Organizational Affiliation
Hôpital Privé Jacques Cartier
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eberhardt Grube, MD
Organizational Affiliation
University Hospital, Bonn
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George D Dangas, MD, PhD
Organizational Affiliation
The Zena and Michael A. Wiener Cardiovascular Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Prodromos Anthopoulos, MD
Organizational Affiliation
The Medicines Company
Official's Role
Study Director
Facility Information:
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
St. Paul´s Hospital Providence Health Care
City
Vancouver
ZIP/Postal Code
V6Z1Y6
Country
Canada
Facility Name
Clinique Pasteur, Unité de Cardiologie Interventionnelle
City
Toulouse
State/Province
Cedex 3
ZIP/Postal Code
31076
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
State/Province
Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
CHU Jean Minjoz, Service de Cardiologie
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
Centre Hospitalier de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France
Facility Name
Department of Cardiology, CHRU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Institut Hospitalier Jacques Cartier
City
Massy
ZIP/Postal Code
91300
Country
France
Facility Name
Service de Cardiologie, Centre Hospitalo-Universitaire, Hôpital Charles-Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
University Heart Centre, Clinic of Inner Medicine 1 Cardiology
City
Jena
State/Province
Lobeda Ost
ZIP/Postal Code
07747
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Klinikum links der Weser Bremen
City
Bremen
ZIP/Postal Code
28277
Country
Germany
Facility Name
Elisabeth-Krankenhaus Essen
City
Essen
ZIP/Postal Code
45257
Country
Germany
Facility Name
Freiburg University
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Asklepios St. Georg Hamburg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universität Leipzig - Herzzentrum GmbH
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universitat Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
LMU Munich, Klinikum der Universität München
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Deutsches Herzzentrum München
City
München
ZIP/Postal Code
80636
Country
Germany
Facility Name
Helios Heart Center Siegburg
City
Siegburg
ZIP/Postal Code
53721
Country
Germany
Facility Name
Ferraroto Hospital, University of Catania
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Ospedale San Raffaele U.O. Cardiologia Interventistica
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Pisana
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo-Forlanini
City
Roma
ZIP/Postal Code
00151
Country
Italy
Facility Name
Policlinico Umberto I, Università La Sapienza
City
Roma
Country
Italy
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435
Country
Netherlands
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Cardiology University Hospital Basel
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Universitätsklinik Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
The Royal Sussex County Hospital
City
Brighton
State/Province
East Sussex
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27208464
Citation
Van Belle E, Hengstenberg C, Lefevre T, Kupatt C, Debry N, Husser O, Pontana F, Kuchcinski G, Deliargyris EN, Mehran R, Bernstein D, Anthopoulos P, Dangas GD; BRAVO-3 MRI Study Investigators. Cerebral Embolism During Transcatheter Aortic Valve Replacement: The BRAVO-3 MRI Study. J Am Coll Cardiol. 2016 Aug 9;68(6):589-599. doi: 10.1016/j.jacc.2016.05.006. Epub 2016 May 18.
Results Reference
derived
PubMed Identifier
26477635
Citation
Dangas GD, Lefevre T, Kupatt C, Tchetche D, Schafer U, Dumonteil N, Webb JG, Colombo A, Windecker S, Ten Berg JM, Hildick-Smith D, Mehran R, Boekstegers P, Linke A, Tron C, Van Belle E, Asgar AW, Fach A, Jeger R, Sardella G, Hink HU, Husser O, Grube E, Deliargyris EN, Lechthaler I, Bernstein D, Wijngaard P, Anthopoulos P, Hengstenberg C; BRAVO-3 Investigators. Bivalirudin Versus Heparin Anticoagulation in Transcatheter Aortic Valve Replacement: The Randomized BRAVO-3 Trial. J Am Coll Cardiol. 2015 Dec 29;66(25):2860-2868. doi: 10.1016/j.jacc.2015.10.003. Epub 2015 Oct 15.
Results Reference
derived

Learn more about this trial

Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH

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