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Safety Study of Apixaban in Recent Acute Coronary Syndrome

Primary Purpose

Acute Coronary Syndrome (ACS)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Apixaban
Apixaban
Placebo
Apixaban
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome (ACS)

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: Recent (< = 7 days) Acute Coronary Syndrome (ACS). Clinically stable on optimal treatment Key Exclusion Criteria: High bleeding risk. Ongoing anticoagulant use. Need for chronic (>3 months) daily nonsteroidal anti-inflammatory drug (NSAID) or chronic high dose acetylsalicylic acid (ASA) use (>325 mg/day

Sites / Locations

  • Scottsdale Cardiovasular Research Institute
  • Los Angeles County & University Of Southern Ca. Medical Cen.
  • Radiant Research,Santa Rosa
  • South Denver Cardiology Associates
  • Watson Clinic Center For Research
  • Heart & Vasc Inst Of Fl
  • Indian River Medical Center
  • Cardiac Disease Specialists, P.C.
  • Georgia Heart Specialists
  • Heartcare Midwest
  • The Care Group, Llc.
  • Iowa Heart Center
  • University Of Kentucky
  • William Beaumont Hospital-Troy
  • New York Cardiovascular Associates
  • Unc Hospitals, Department Of Medicine
  • Dumc
  • Carolina Heart Specialists
  • Piedmont Cardiology Associates
  • Wake Forest Univ Health Sciences
  • Midwest Cardiology Research Foundation
  • The Dayton Heart Center
  • Oklahoma Cardiovascular Research Group
  • Geisinger Clinic - Cardiology
  • Penn State Milton S. Hershey Medical Center
  • Rhode Island Hospital
  • Cardiovascular Associates, P.C
  • University Of Texas Medical School - San Antonio
  • Tyler Cardiovascular Consultants
  • Virginia Commonwealth University
  • Local Institution
  • Local Institution
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

A1

A2

A3

A4

Arm Description

Outcomes

Primary Outcome Measures

Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses
Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The primary outcome is based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B. The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups (10mg BID, 20mg QD) and the resulting lower duration of exposure for these groups.

Secondary Outcome Measures

Number of Participants With a Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants
Events were adjudicated by the Clinical Events Committee (CEC). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B.
Event Rate for Adjudicated All Bleeding Events During the Treatment Period - Treated Participants With Placebo or Apixaban Low Doses
Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events includes major bleeding, clinically relevant non-major bleeding and minor bleeding. Treatment Period refers to the period from first dose through 2 days, or through 30 days for Serious Adverse Event (SAE) tabulations, after discontinuation of study drug. Data in this outcome are combined across Phase A and Phase B.
Number of Participants With a Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants
Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B
Event Rate of Confirmed Adjudicated Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses
Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the Clinical Events Committee. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%).
Number of Participants With Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B
Phase B Adjusted Intended Treatment Period=day of randomization and ends on termination date of high dose apixaban, 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.
Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Phase B Adjusted Treatment Period- Treated Participants Randomized in Phase B
Bleeding was assessed using ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups and the lower duration of exposure. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).
Event Rate for Adjudicated All Bleeding Events During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B
Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events included major bleeding, clinically relevant non-major bleeding and minor bleeding. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).
Number of Participants With Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B
Phase B Adjusted Intended Treatment Period=day of randomization and ends on 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.
Event Rate of Confirmed Adjudicated Major Bleeding During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B
Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%).

Full Information

First Posted
April 10, 2006
Last Updated
November 25, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00313300
Brief Title
Safety Study of Apixaban in Recent Acute Coronary Syndrome
Official Title
A Phase 2, Placebo-Controlled, Randomized, Double Blind, Parallel Arm, Dose Ranging Study to Evaluate Safety and Efficacy of Apixaban in Patients With a Recent Acute Coronary Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this clinical research study is to determine whether apixaban will be safe in people who have recently had unstable angina or a heart attack.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome (ACS)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1741 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Active Comparator
Arm Title
A2
Arm Type
Experimental
Arm Title
A3
Arm Type
Placebo Comparator
Arm Title
A4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Apixaban
Intervention Description
Tablets, Oral, 2.5 mg, twice daily, 26 weeks
Intervention Type
Drug
Intervention Name(s)
Apixaban
Intervention Description
Tablets, Oral, 10 mg, once daily, 26 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, 0, twice daily, 26 weeks
Intervention Type
Drug
Intervention Name(s)
Apixaban
Intervention Description
Tablets, Oral 10 mg, twice daily, 26 weeks
Primary Outcome Measure Information:
Title
Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses
Description
Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The primary outcome is based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B. The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups (10mg BID, 20mg QD) and the resulting lower duration of exposure for these groups.
Time Frame
From first dose of study drug (Day 1) to last dose plus 2 days, up to Year 2 of the Study
Secondary Outcome Measure Information:
Title
Number of Participants With a Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants
Description
Events were adjudicated by the Clinical Events Committee (CEC). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B.
Time Frame
Randomization to 182 days after randomization (183 days)
Title
Event Rate for Adjudicated All Bleeding Events During the Treatment Period - Treated Participants With Placebo or Apixaban Low Doses
Description
Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events includes major bleeding, clinically relevant non-major bleeding and minor bleeding. Treatment Period refers to the period from first dose through 2 days, or through 30 days for Serious Adverse Event (SAE) tabulations, after discontinuation of study drug. Data in this outcome are combined across Phase A and Phase B.
Time Frame
first dose (Day 1) to last dose plus 2 days (or for SAEs, plus 30 days), up to Year 2 of the Study
Title
Number of Participants With a Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants
Description
Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B
Time Frame
Day of randomization to 182 days after day of randomization (183 days)
Title
Event Rate of Confirmed Adjudicated Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses
Description
Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the Clinical Events Committee. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%).
Time Frame
from first dose (Day 1) to last dose plus 2 days, up to Year 2 of the Study
Title
Number of Participants With Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B
Description
Phase B Adjusted Intended Treatment Period=day of randomization and ends on termination date of high dose apixaban, 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.
Time Frame
Day of randomization and ends on high dose termination date, 1-Oct-2007
Title
Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Phase B Adjusted Treatment Period- Treated Participants Randomized in Phase B
Description
Bleeding was assessed using ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups and the lower duration of exposure. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).
Time Frame
From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007
Title
Event Rate for Adjudicated All Bleeding Events During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B
Description
Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events included major bleeding, clinically relevant non-major bleeding and minor bleeding. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).
Time Frame
From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007
Title
Number of Participants With Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B
Description
Phase B Adjusted Intended Treatment Period=day of randomization and ends on 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.
Time Frame
Day of randomization up to high dose termination, 1-Oct-2007
Title
Event Rate of Confirmed Adjudicated Major Bleeding During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B
Description
Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%).
Time Frame
From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Recent (< = 7 days) Acute Coronary Syndrome (ACS). Clinically stable on optimal treatment Key Exclusion Criteria: High bleeding risk. Ongoing anticoagulant use. Need for chronic (>3 months) daily nonsteroidal anti-inflammatory drug (NSAID) or chronic high dose acetylsalicylic acid (ASA) use (>325 mg/day
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Scottsdale Cardiovasular Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Los Angeles County & University Of Southern Ca. Medical Cen.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Radiant Research,Santa Rosa
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
South Denver Cardiology Associates
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Watson Clinic Center For Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Heart & Vasc Inst Of Fl
City
Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
Country
United States
Facility Name
Indian River Medical Center
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Cardiac Disease Specialists, P.C.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Georgia Heart Specialists
City
Covington
State/Province
Georgia
ZIP/Postal Code
30014
Country
United States
Facility Name
Heartcare Midwest
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
The Care Group, Llc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Iowa Heart Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
University Of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
William Beaumont Hospital-Troy
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
New York Cardiovascular Associates
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Unc Hospitals, Department Of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Dumc
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Carolina Heart Specialists
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Piedmont Cardiology Associates
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Wake Forest Univ Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Midwest Cardiology Research Foundation
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
The Dayton Heart Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Oklahoma Cardiovascular Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Geisinger Clinic - Cardiology
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Cardiovascular Associates, P.C
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
University Of Texas Medical School - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Tyler Cardiovascular Consultants
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Local Institution
City
Feldkirch
ZIP/Postal Code
6800
Country
Austria
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
Local Institution
City
Huy
State/Province
Luik
ZIP/Postal Code
4500
Country
Belgium
Facility Name
Local Institution
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Local Institution
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Local Institution
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Facility Name
Local Institution
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Local Institution
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6K 4C1
Country
Canada
Facility Name
Local Institution
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
Local Institution
City
St. John'S
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Local Institution
City
Belleville
State/Province
Ontario
ZIP/Postal Code
K8N1E6
Country
Canada
Facility Name
Local Institution
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7L 1B9
Country
Canada
Facility Name
Local Institution
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Local Institution
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Local Institution
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 1B9
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
Local Institution
City
St. Charles-Borromee
State/Province
Quebec
ZIP/Postal Code
J6E 6J2
Country
Canada
Facility Name
Local Institution
City
Terrebonne
State/Province
Quebec
ZIP/Postal Code
J6V 2H2
Country
Canada
Facility Name
Local Institution
City
Arhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Local Institution
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Local Institution
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Local Institution
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Local Institution
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Local Institution
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Local Institution
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Local Institution
City
Randers
ZIP/Postal Code
DK-8900
Country
Denmark
Facility Name
Local Institution
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
Local Institution
City
Cholet
ZIP/Postal Code
49300
Country
France
Facility Name
Local Institution
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Local Institution
City
Nantes Cedex 01
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Local Institution
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Local Institution
City
Roubaix Cedex 1
ZIP/Postal Code
59056
Country
France
Facility Name
Local Institution
City
Toulouse
ZIP/Postal Code
31403
Country
France
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
12559
Country
Germany
Facility Name
Local Institution
City
Duren
ZIP/Postal Code
52351
Country
Germany
Facility Name
Local Institution
City
Halle / Saale
ZIP/Postal Code
06120
Country
Germany
Facility Name
Local Institution
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution
City
Krefeld
ZIP/Postal Code
47805
Country
Germany
Facility Name
Local Institution
City
Langen
ZIP/Postal Code
63225
Country
Germany
Facility Name
Local Institution
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Local Institution
City
Witten
ZIP/Postal Code
58455
Country
Germany
Facility Name
Local Institution
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Local Institution
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
Local Institution
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Local Institution
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Local Institution
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Local Institution
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Local Institution
City
Jerusalem
ZIP/Postal Code
91240
Country
Israel
Facility Name
Local Institution
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Local Institution
City
Nazareth
ZIP/Postal Code
16100
Country
Israel
Facility Name
Local Institution
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Local Institution
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Local Institution
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Local Institution
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Local Institution
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Local Institution
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Local Institution
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Local Institution
City
Bydgoszcz
ZIP/Postal Code
85-826
Country
Poland
Facility Name
Local Institution
City
Cracow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Local Institution
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Local Institution
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Facility Name
Local Institution
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Local Institution
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
Local Institution
City
Opole
ZIP/Postal Code
45-418
Country
Poland
Facility Name
Local Institution
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Local Institution
City
Zielona Gora
ZIP/Postal Code
65-046
Country
Poland
Facility Name
Local Institution
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
111020
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
115487
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
119620
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
129327
Country
Russian Federation
Facility Name
Local Institution
City
Saint Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
Local Institution
City
Saint Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
Local Institution
City
Saint Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Local Institution
City
Saint Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Local Institution
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Local Institution
City
St. Petersburg
ZIP/Postal Code
194156
Country
Russian Federation
Facility Name
Local Institution
City
St.Petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
Local Institution
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Local Institution
City
Yaroslav
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Local Institution
City
Baracaldo (Vizcaya)
ZIP/Postal Code
48903
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution
City
Hospitalet Llobregat Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Local Institution
City
Leon
ZIP/Postal Code
24071
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Local Institution
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Local Institution
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Local Institution
City
Tarragona
ZIP/Postal Code
43007
Country
Spain
Facility Name
Local Institution
City
Valladolid
ZIP/Postal Code
47010
Country
Spain
Facility Name
Local Institution
City
Villajoyosa
ZIP/Postal Code
03570
Country
Spain
Facility Name
Local Institution
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Local Institution
City
Goteborg
ZIP/Postal Code
SE-416 85
Country
Sweden
Facility Name
Local Institution
City
Malmo
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Local Institution
City
Orebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Local Institution
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Local Institution
City
Sundsvall
ZIP/Postal Code
851 86
Country
Sweden
Facility Name
Local Institution
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Local Institution
City
Stockport
State/Province
Cheshire
ZIP/Postal Code
SK2 7JE
Country
United Kingdom
Facility Name
Local Institution
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Local Institution
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH16 4SB
Country
United Kingdom
Facility Name
Local Institution
City
Portadown
State/Province
N. Ireland
ZIP/Postal Code
BT63 5QQ
Country
United Kingdom
Facility Name
Local Institution
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Local Institution
City
York
State/Province
Yorkshire
ZIP/Postal Code
YO31 8HE
Country
United Kingdom
Facility Name
Local Institution
City
Croydon
ZIP/Postal Code
CR7 7YE
Country
United Kingdom
Facility Name
Local Institution
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19470889
Citation
APPRAISE Steering Committee and Investigators; Alexander JH, Becker RC, Bhatt DL, Cools F, Crea F, Dellborg M, Fox KA, Goodman SG, Harrington RA, Huber K, Husted S, Lewis BS, Lopez-Sendon J, Mohan P, Montalescot G, Ruda M, Ruzyllo W, Verheugt F, Wallentin L. Apixaban, an oral, direct, selective factor Xa inhibitor, in combination with antiplatelet therapy after acute coronary syndrome: results of the Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) trial. Circulation. 2009 Jun 9;119(22):2877-85. doi: 10.1161/CIRCULATIONAHA.108.832139. Epub 2009 May 26.
Results Reference
derived

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Safety Study of Apixaban in Recent Acute Coronary Syndrome

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