A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction (ACCOAST)
Primary Purpose
Acute Coronary Syndromes
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Prasugrel
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndromes focused on measuring Acute Coronary Syndromes, Heart Disease, Percutaneous Coronary Intervention, P2Y12, NSTEMI
Eligibility Criteria
Inclusion Criteria:
- Have acute coronary syndrome consisting of non-ST-segment elevation with elevated troponin
- Scheduled for coronary angiography/PCI greater than or equal to 2 and less than 24 hours from time of planned randomization, but no more than 48 hours from randomization
- Must be eligible for treatment with prasugrel, aspirin (ASA), and a glycoprotein IIb/IIIa receptor (GPIIb/IIIa) inhibitor as per respective labels
- May be on a maintenance dose of clopidogrel 75 mg and must be able to switch to prasugrel
- Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital
Exclusion Criteria:
- Present with ST-segment elevation myocardial infarction (STEMI) at the time of entry or randomization
- Have cardiogenic shock
- Have refractory ventricular arrhythmias
- Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF)
- Have had cardiac arrest within 1 week of entry or randomization into the study
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Non pre-treatment
Split Loading Dose
Arm Description
A placebo oral loading dose is given at the time of diagnosis and a 60 milligrams (mg) oral loading dose of prasugrel is given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
A 30 mg oral loading dose of prasugrel is given at diagnosis and a 30 mg oral dose of prasugrel is given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days
Outcomes
Primary Outcome Measures
The Percentage of Participants With Occurrence of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Urgent Revascularization (UR), or Glycoprotein (GP) IIb/IIIa Inhibitor Bailout
The percentage of participants is the total number of participants experiencing a CV death, MI, stroke, UR or GPIIb/IIIa Inhibitor bailout divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Secondary Outcome Measures
Percentage of Participants With All-Cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke Through 30 Days From First Loading Dose (LD)
The percentage of participants is the total number of participants experiencing a CV death, MI, or stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Percentage of Participants With Incidence of Cardiovascular (CV) Death or Myocardial Infarction (MI) Through 30 Days From First Loading Dose (LD)
The percentage of participants is the total number of participants experiencing a CV death or MI divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Urgent Revascularization (UR) Through 30 Days From First Loading Dose (LD)
The percentage of participants is the total number of participants experiencing a CV death, MI, or UR divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Percentage of Participants With Incidence of Cardiovascular (CV) Death Through 30 Days From First Loading Dose (LD)
The percentage of participants is the total number of participants experiencing a CV death divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Percentage of Participants With Incidence of Definite or Probable Stent Thrombosis (ST) According to the Academic Research Consortium (ARC) Criteria Through 30 Days From First Loading Dose (LD)
ARC criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. The percentage of participants is the total number of participants experiencing a definite or probable stent thrombosis divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Percentage of Participants With All-cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Through 30 Days From First Loading Dose (LD)
The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI)
Standardized troponin is defined as the ratio of the assayed troponin value divided by the upper limit of normal (ULN). Least Squares (LS) means were obtained from an Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and baseline standardized troponin as a covariate.
Percentage of Participants With Incidence of All Coronary Artery Bypass Graft (CABG) or Non-CABG Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding
The percentage of participants is the total number of participants experiencing a CABG or non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Full Information
NCT ID
NCT01015287
First Posted
November 17, 2009
Last Updated
January 17, 2014
Sponsor
Eli Lilly and Company
Collaborators
Daiichi Sankyo Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01015287
Brief Title
A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction
Acronym
ACCOAST
Official Title
A Comparison of Prasugrel at the Time of Percutaneous Coronary Intervention (PCI) Or as Pretreatment At the Time of Diagnosis in Patients With Non-ST-Elevation Myocardial Infarction (NSTEMI): The ACCOAST Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
Daiichi Sankyo Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this trial is to investigate the potential benefits/risks regarding pretreatment with prasugrel in non-ST-elevation myocardial infarction (NSTEMI) participants with elevated troponin scheduled for coronary angiography/percutaneous coronary intervention (PCI).
Detailed Description
This trial consists of two arms. One arm is a non pre-treatment arm. Participants in this arm will receive placebo immediately after NSTEMI diagnosis and prior to the diagnostic coronary angiography. A 60 mg prasugrel loading dose will be given immediately after coronary angiography when proceeding to PCI. Subsequently, participants will receive daily maintenance doses of prasugrel until day 30. Participants who are greater than or equal to 75 years of age or who have a body weight less than 60 kilograms (kg) will receive 5 mg oral dose daily. All others will receive a 10 mg oral daily maintenance dose for 30 days.
The other arm is a pre-treatment arm where participants will receive a split loading dose regimen with 30 mg of prasugrel administered immediately after NSTEMI diagnosis and prior to diagnostic coronary angiography. The remainder of the loading dose (30 mg) will be administered when the participants are proceeding to PCI. Subsequently, participants will receive daily maintenance doses of prasugrel until day 30. Participants who are greater than or equal to 75 years of age or who have a body weight less than 60 kg will receive 5 mg oral dose daily. All others will receive a 10 mg oral daily maintenance dose for 30 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndromes
Keywords
Acute Coronary Syndromes, Heart Disease, Percutaneous Coronary Intervention, P2Y12, NSTEMI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4033 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non pre-treatment
Arm Type
Experimental
Arm Description
A placebo oral loading dose is given at the time of diagnosis and a 60 milligrams (mg) oral loading dose of prasugrel is given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
Arm Title
Split Loading Dose
Arm Type
Experimental
Arm Description
A 30 mg oral loading dose of prasugrel is given at diagnosis and a 30 mg oral dose of prasugrel is given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered once orally
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Other Intervention Name(s)
LY640315, Efient, Effient, CS-747
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
The Percentage of Participants With Occurrence of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Urgent Revascularization (UR), or Glycoprotein (GP) IIb/IIIa Inhibitor Bailout
Description
The percentage of participants is the total number of participants experiencing a CV death, MI, stroke, UR or GPIIb/IIIa Inhibitor bailout divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time Frame
First loading dose (LD) through 7 days after first LD
Secondary Outcome Measure Information:
Title
Percentage of Participants With All-Cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
Description
The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time Frame
First loading dose (LD) through 7 days after first LD
Title
Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke Through 30 Days From First Loading Dose (LD)
Description
The percentage of participants is the total number of participants experiencing a CV death, MI, or stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time Frame
First LD through 30 days after first LD
Title
Percentage of Participants With Incidence of Cardiovascular (CV) Death or Myocardial Infarction (MI) Through 30 Days From First Loading Dose (LD)
Description
The percentage of participants is the total number of participants experiencing a CV death or MI divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time Frame
First LD through 30 days after first LD
Title
Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Urgent Revascularization (UR) Through 30 Days From First Loading Dose (LD)
Description
The percentage of participants is the total number of participants experiencing a CV death, MI, or UR divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time Frame
First LD through 30 days after first LD
Title
Percentage of Participants With Incidence of Cardiovascular (CV) Death Through 30 Days From First Loading Dose (LD)
Description
The percentage of participants is the total number of participants experiencing a CV death divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time Frame
First LD through 30 days after first LD
Title
Percentage of Participants With Incidence of Definite or Probable Stent Thrombosis (ST) According to the Academic Research Consortium (ARC) Criteria Through 30 Days From First Loading Dose (LD)
Description
ARC criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. The percentage of participants is the total number of participants experiencing a definite or probable stent thrombosis divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time Frame
First LD through 30 days after first LD
Title
Percentage of Participants With All-cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Through 30 Days From First Loading Dose (LD)
Description
The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time Frame
First LD through 30 days after first LD
Title
Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI)
Description
Standardized troponin is defined as the ratio of the assayed troponin value divided by the upper limit of normal (ULN). Least Squares (LS) means were obtained from an Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and baseline standardized troponin as a covariate.
Time Frame
Baseline, before PCI (not greater than 48 hours after randomization)
Title
Percentage of Participants With Incidence of All Coronary Artery Bypass Graft (CABG) or Non-CABG Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding
Description
The percentage of participants is the total number of participants experiencing a CABG or non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
Time Frame
First loading dose (LD) through 7 days after first LD
Other Pre-specified Outcome Measures:
Title
Summary of All-Cause Death
Description
All deaths, regardless of possible relatedness, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table.
Time Frame
Randomization through 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have acute coronary syndrome consisting of non-ST-segment elevation with elevated troponin
Scheduled for coronary angiography/PCI greater than or equal to 2 and less than 24 hours from time of planned randomization, but no more than 48 hours from randomization
Must be eligible for treatment with prasugrel, aspirin (ASA), and a glycoprotein IIb/IIIa receptor (GPIIb/IIIa) inhibitor as per respective labels
May be on a maintenance dose of clopidogrel 75 mg and must be able to switch to prasugrel
Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital
Exclusion Criteria:
Present with ST-segment elevation myocardial infarction (STEMI) at the time of entry or randomization
Have cardiogenic shock
Have refractory ventricular arrhythmias
Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF)
Have had cardiac arrest within 1 week of entry or randomization into the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Braunau Am Inn
ZIP/Postal Code
5280
Country
Austria
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Graz
ZIP/Postal Code
8020
Country
Austria
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Vienna
ZIP/Postal Code
A1090
Country
Austria
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
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City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
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City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
Vancouver
Country
Canada
Facility Name
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City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
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City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
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City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
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City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
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City
Brno
ZIP/Postal Code
625 00
Country
Czech Republic
Facility Name
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City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
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City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
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City
Plzen
ZIP/Postal Code
30460
Country
Czech Republic
Facility Name
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City
Prague
ZIP/Postal Code
169 02
Country
Czech Republic
Facility Name
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City
Usti Nad Labem
ZIP/Postal Code
40113
Country
Czech Republic
Facility Name
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City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
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City
Bastia
ZIP/Postal Code
20600
Country
France
Facility Name
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City
Bron
ZIP/Postal Code
69500
Country
France
Facility Name
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City
Caluire Et Cuire
ZIP/Postal Code
69300
Country
France
Facility Name
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City
Cannes Cedex
ZIP/Postal Code
06401
Country
France
Facility Name
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City
Chateauroux
ZIP/Postal Code
36019
Country
France
Facility Name
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City
Corbeil Essonnes
ZIP/Postal Code
91106
Country
France
Facility Name
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City
Lagny Sur Marne
ZIP/Postal Code
77405
Country
France
Facility Name
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City
Le Coudray
ZIP/Postal Code
28630
Country
France
Facility Name
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City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
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City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
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City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
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City
Metz Tessy
ZIP/Postal Code
74370
Country
France
Facility Name
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City
Metz
ZIP/Postal Code
57085
Country
France
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Montauban
ZIP/Postal Code
82017
Country
France
Facility Name
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City
Montreuil
ZIP/Postal Code
93105
Country
France
Facility Name
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City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Pau Cedex
ZIP/Postal Code
64046
Country
France
Facility Name
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City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
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City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
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City
Valence
ZIP/Postal Code
26953
Country
France
Facility Name
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City
Vannes
ZIP/Postal Code
56017
Country
France
Facility Name
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City
Vienne
ZIP/Postal Code
38209
Country
France
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Facility Name
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City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
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City
Bad Segeberg
ZIP/Postal Code
23795
Country
Germany
Facility Name
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City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
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City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
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City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
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City
Dachau
ZIP/Postal Code
85221
Country
Germany
Facility Name
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City
Eutin
ZIP/Postal Code
23701
Country
Germany
Facility Name
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City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
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City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
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City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
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City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
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City
Heidelberg
ZIP/Postal Code
D-69120
Country
Germany
Facility Name
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City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
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City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
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City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Munich
ZIP/Postal Code
80336
Country
Germany
Facility Name
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City
Rastatt
ZIP/Postal Code
76437
Country
Germany
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Villingen-Schwenningen
ZIP/Postal Code
78050
Country
Germany
Facility Name
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City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Beer Yaakov
ZIP/Postal Code
70300
Country
Israel
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Tiberias
ZIP/Postal Code
15208
Country
Israel
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Chieti
ZIP/Postal Code
66013
Country
Italy
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Grosseto
ZIP/Postal Code
58100
Country
Italy
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Legnano
ZIP/Postal Code
20025
Country
Italy
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Lucca
Country
Italy
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Massa
ZIP/Postal Code
54100
Country
Italy
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Napoli
ZIP/Postal Code
80100
Country
Italy
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Prato
ZIP/Postal Code
50047
Country
Italy
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
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City
Rome
ZIP/Postal Code
00100
Country
Italy
Facility Name
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City
Torino
ZIP/Postal Code
10100
Country
Italy
Facility Name
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City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
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City
Venezia
ZIP/Postal Code
30035
Country
Italy
Facility Name
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City
Liepaja
ZIP/Postal Code
3414
Country
Latvia
Facility Name
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City
Riga
ZIP/Postal Code
1038
Country
Latvia
Facility Name
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City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
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City
Klaipedos
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
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City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
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City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
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City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
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City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
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City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
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City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
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City
Tiel
ZIP/Postal Code
4002 WP
Country
Netherlands
Facility Name
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City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
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City
Belchatow
ZIP/Postal Code
97-400
Country
Poland
Facility Name
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City
Chrzanow
ZIP/Postal Code
32-500
Country
Poland
Facility Name
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City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Facility Name
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City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Facility Name
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City
Klodzko
ZIP/Postal Code
57-300
Country
Poland
Facility Name
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City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
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City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
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City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
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City
Mielec
ZIP/Postal Code
39-300
Country
Poland
Facility Name
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City
Naleczow
ZIP/Postal Code
24-140
Country
Poland
Facility Name
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City
Nowy Sacz
ZIP/Postal Code
33-300
Country
Poland
Facility Name
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City
Nowy Targ
ZIP/Postal Code
34-400
Country
Poland
Facility Name
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City
Nysa
ZIP/Postal Code
48-300
Country
Poland
Facility Name
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City
Ostrowiec Swietokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
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City
Oswiecim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
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City
Polanica-Zdroj
ZIP/Postal Code
57-320
Country
Poland
Facility Name
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City
Pulawy
ZIP/Postal Code
24-100
Country
Poland
Facility Name
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City
Radom
ZIP/Postal Code
26-617
Country
Poland
Facility Name
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City
Sanok
ZIP/Postal Code
38-500
Country
Poland
Facility Name
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City
Stalowa Wola
ZIP/Postal Code
37-450
Country
Poland
Facility Name
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City
Starogard Gdanski
ZIP/Postal Code
82-200
Country
Poland
Facility Name
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City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Facility Name
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City
Warsaw
ZIP/Postal Code
04-628
Country
Poland
Facility Name
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City
Wejherowo
ZIP/Postal Code
84-200
Country
Poland
Facility Name
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City
Wroclaw
ZIP/Postal Code
53-114
Country
Poland
Facility Name
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City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
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City
Carnaxide
ZIP/Postal Code
2794-006
Country
Portugal
Facility Name
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City
Faro
ZIP/Postal Code
8000-386
Country
Portugal
Facility Name
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City
Leiria
ZIP/Postal Code
2410-197
Country
Portugal
Facility Name
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City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
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City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
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City
Banska Bystrica
ZIP/Postal Code
97401
Country
Slovakia
Facility Name
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City
Kosice
ZIP/Postal Code
04011
Country
Slovakia
Facility Name
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City
Nitra
ZIP/Postal Code
94901
Country
Slovakia
Facility Name
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City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
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City
Adana
ZIP/Postal Code
1330
Country
Turkey
Facility Name
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City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Facility Name
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City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
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City
Fatih
ZIP/Postal Code
34300
Country
Turkey
Facility Name
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City
Isparta
ZIP/Postal Code
32100
Country
Turkey
Facility Name
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City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Facility Name
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City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
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City
Kocaeli
ZIP/Postal Code
41900
Country
Turkey
Facility Name
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City
Sisli
ZIP/Postal Code
34381
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
30819358
Citation
Silvain J, Rakowski T, Lattuca B, Liu Z, Bolognese L, Goldstein P, Hamm C, Tanguay JF, Ten Berg J, Widimsky P, Miller D, Portal JJ, Collet JP, Vicaut E, Montalescot G, Dudek D; ACCOAST Investigators. Interval From Initiation of Prasugrel to Coronary Angiography in Patients With Non-ST-Segment Elevation Myocardial Infarction. J Am Coll Cardiol. 2019 Mar 5;73(8):906-914. doi: 10.1016/j.jacc.2018.11.055.
Results Reference
derived
PubMed Identifier
27151605
Citation
Porto I, Bolognese L, Dudek D, Goldstein P, Hamm C, Tanguay JF, Ten Berg J, Widimsky P, Le Gall N, Zagar AJ, LeNarz LA, Miller D, Montalescot G; ACCOAST Investigators. Impact of Access Site on Bleeding and Ischemic Events in Patients With Non-ST-Segment Elevation Myocardial Infarction Treated With Prasugrel: The ACCOAST Access Substudy. JACC Cardiovasc Interv. 2016 May 9;9(9):897-907. doi: 10.1016/j.jcin.2016.01.041.
Results Reference
derived
PubMed Identifier
26542513
Citation
Dudek D, Dziewierz A, Widimsky P, Bolognese L, Goldstein P, Hamm C, Tanguay JF, LeNarz L, Miller DL, Brown E, Ten Berg J, Montalescot G; ACCOAST Investigators. Impact of prasugrel pretreatment and timing of coronary artery bypass grafting on clinical outcomes of patients with non-ST-segment elevation myocardial infarction: From the A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST-Elevation Myocardial Infarction (ACCOAST) study. Am Heart J. 2015 Nov;170(5):1025-1032.e2. doi: 10.1016/j.ahj.2015.07.017. Epub 2015 Jul 26.
Results Reference
derived
PubMed Identifier
26060122
Citation
Widimsky P, Motovska Z, Bolognese L, Dudek D, Hamm C, Tanguay JF, Ten Berg J, Brown E, LeNarz L, Miller DL, Montalescot G; ACCOAST Investigators. Predictors of bleeding in patients with acute coronary syndromes treated with prasugrel. Heart. 2015 Aug;101(15):1219-24. doi: 10.1136/heartjnl-2015-307686. Epub 2015 Jun 9.
Results Reference
derived
PubMed Identifier
25524333
Citation
Montalescot G, Collet JP, Ecollan P, Bolognese L, Ten Berg J, Dudek D, Hamm C, Widimsky P, Tanguay JF, Goldstein P, Brown E, Miller DL, LeNarz L, Vicaut E; ACCOAST Investigators. Effect of prasugrel pre-treatment strategy in patients undergoing percutaneous coronary intervention for NSTEMI: the ACCOAST-PCI study. J Am Coll Cardiol. 2014 Dec 23;64(24):2563-2571. doi: 10.1016/j.jacc.2014.08.053.
Results Reference
derived
PubMed Identifier
23991622
Citation
Montalescot G, Bolognese L, Dudek D, Goldstein P, Hamm C, Tanguay JF, ten Berg JM, Miller DL, Costigan TM, Goedicke J, Silvain J, Angioli P, Legutko J, Niethammer M, Motovska Z, Jakubowski JA, Cayla G, Visconti LO, Vicaut E, Widimsky P; ACCOAST Investigators. Pretreatment with prasugrel in non-ST-segment elevation acute coronary syndromes. N Engl J Med. 2013 Sep 12;369(11):999-1010. doi: 10.1056/NEJMoa1308075. Epub 2013 Sep 1.
Results Reference
derived
PubMed Identifier
21473962
Citation
Montalescot G, Bolognese L, Dudek D, Goldstein P, Hamm C, Tanguay JF, ten Berg J, Widimsky P, Luo J, Miller DL, Goedicke J. A comparison of prasugrel at the time of percutaneous coronary intervention or as pretreatment at the time of diagnosis in patients with non-ST-segment elevation myocardial infarction: design and rationale for the ACCOAST study. Am Heart J. 2011 Apr;161(4):650-656.e1. doi: 10.1016/j.ahj.2010.10.017. Epub 2011 Feb 25.
Results Reference
derived
Learn more about this trial
A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction
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