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A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome (GEMINI ACS 1)

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Acetylsalicylic acid
Rivaroxaban
Clopidogrel
Ticagrelor
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome, Myocardial infarction, Unstable angina, Acetylsalicylic acid, Rivaroxaban, JNJ-39039039, Bay 59-7939, Xarelto, Clopidogrel, Ticagrelor, Plavix, Brilinta, Effient

Eligibility Criteria

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

Inclusion Criteria:

  • Participants, 18 years or older, must have symptoms suggestive of acute coronary syndrome (ACS) (angina, or symptoms thought to be equivalent) within 48 hours of hospital presentation, or developed ACS while being hospitalized, and has a diagnosis of: a) ST segment elevation myocardial infarction (STEMI); b) non-ST-segment elevation acute coronary syndrome (NSTE-ACS). However, participant who is 54 years of age or younger must also have either diabetes mellitus or a history of a prior myocardial infarction (MI), in addition to the presenting ACS event
  • Participant must be randomized within the screening window of 10 days after hospital admission for the index ACS event. Participant should have received acute phase treatment for the index ACS, such as intravenous anticoagulant or antiplatelet, and are receiving maintenance dual antiplatelet therapy (DAPT) with either clopidogrel plus acetyl salicylic acid (ASA), or ticagrelor plus ASA, with the intent to continue the treatment with a platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor) after randomization
  • Participants must agree to provide a pharmacogenomics deoxyribonucleic acid (DNA) sample

Exclusion Criteria:

  • Participant has any conditions that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk
  • Participant with a prior stroke of any etiology or transient ischemic attack (TIA)
  • Participant who received thrombolytic therapy as treatment for the index ACS event cannot be enrolled in the ticagrelor stratum
  • Participant has anticipated need for chronic administration of omeprazole or esomeprazole concomitantly with clopidogrel
  • Participant has known allergy or intolerance to ASA or rivaroxaban

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Stratum 1/ASA

Stratum 1/Rivaroxaban

Stratum 2/ASA

Stratum 2/Rivaroxaban

Arm Description

Acetylsalicylic acid (ASA) 100 milligram (mg) enteric-coated tablet once daily orally along with clopidogrel 75 mg once daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.

Rivaroxaban 2.5 mg tablet twice daily orally along with clopidogrel 75 mg once daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.

ASA 100 mg enteric-coated tablet once daily orally along with ticagrelor 90 mg twice daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.

Rivaroxaban 2.5 mg tablet twice daily orally along with ticagrelor 90 mg twice daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.

Outcomes

Primary Outcome Measures

Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events
Non CABG-related TIMI clinically significant bleeding events are sum of non CABG-related TIMI major bleeding events, TIMI minor bleeding events and TIMI bleeding events requiring medical attention. Major: any symptomatic intracranial bleeding: clinically overt signs of hemorrhage with hemoglobin (Hb) drop of greater than or equal to (>=)5 gram per deciliter (g/dl) (or absolute drop in hematocrit of >=15%) and fatal bleeding (results in death within 7 days); Minor: clinically overt sign of hemorrhage with Hb drop of 3 - <5 g/dl (or drop in hematocrit of 9 - <15%); requiring medical attention: bleeding event that required medical, surgical treatment/laboratory evaluation and did not meet criteria for major/minor bleeding event.

Secondary Outcome Measures

Full Information

First Posted
November 13, 2014
Last Updated
November 30, 2017
Sponsor
Janssen Research & Development, LLC
Collaborators
Bayer, Duke Clinical Research Institute, Harvard Medical School (HMS and HSDM)
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1. Study Identification

Unique Protocol Identification Number
NCT02293395
Brief Title
A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome
Acronym
GEMINI ACS 1
Official Title
A Randomized, Double-Blind, Double-Dummy, Active-controlled, Parallel-group, Multicenter Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Subjects With Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 20, 2015 (Actual)
Primary Completion Date
October 14, 2016 (Actual)
Study Completion Date
October 14, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
Collaborators
Bayer, Duke Clinical Research Institute, Harvard Medical School (HMS and HSDM)

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to estimate the risk of bleeding with rivaroxaban, compared with acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in participants with a recent acute coronary syndrome (ACS: including ST segment elevation myocardial infarction [STEMI] and non-ST-segment elevation acute coronary syndrome [NSTE-ACS]).
Detailed Description
This is a prospective, randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), active-controlled (study in which the experimental treatment or procedure is compared to a standard treatment or procedure), parallel group (each group of participants will be treated at the same time), multicenter (when more than one hospital or medical school team work on a medical research study) study in participants with a recent ACS (STEMI or NSTE-ACS). All the eligible participants receiving background treatment of ASA plus clopidogrel (Stratum 1) or ASA plus ticagrelor (Stratum 2) will be randomly assigned to either receive ASA or rivaroxaban on background of P2Y12 receptor antagonists treatment. This study will include 3 phases: Screening Phase (up to 10 days, before study start on Day 1), Double-blind Treatment Phase (up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier), and Follow-up Phase (up to 30 days). Participants' safety will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Acute Coronary Syndrome, Myocardial infarction, Unstable angina, Acetylsalicylic acid, Rivaroxaban, JNJ-39039039, Bay 59-7939, Xarelto, Clopidogrel, Ticagrelor, Plavix, Brilinta, Effient

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3037 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stratum 1/ASA
Arm Type
Active Comparator
Arm Description
Acetylsalicylic acid (ASA) 100 milligram (mg) enteric-coated tablet once daily orally along with clopidogrel 75 mg once daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.
Arm Title
Stratum 1/Rivaroxaban
Arm Type
Experimental
Arm Description
Rivaroxaban 2.5 mg tablet twice daily orally along with clopidogrel 75 mg once daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.
Arm Title
Stratum 2/ASA
Arm Type
Active Comparator
Arm Description
ASA 100 mg enteric-coated tablet once daily orally along with ticagrelor 90 mg twice daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.
Arm Title
Stratum 2/Rivaroxaban
Arm Type
Experimental
Arm Description
Rivaroxaban 2.5 mg tablet twice daily orally along with ticagrelor 90 mg twice daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic acid
Other Intervention Name(s)
Aspirin
Intervention Description
ASA 100 mg enteric-coated tablet once daily orally.
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Other Intervention Name(s)
JNJ-39039039, Bay 59-7939, Xarelto
Intervention Description
Rivaroxaban 2.5 mg tablet twice daily orally.
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix
Intervention Description
Clopidogrel 75 mg once daily orally.
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
Brilinta
Intervention Description
Ticagrelor 90 mg twice daily orally.
Primary Outcome Measure Information:
Title
Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events
Description
Non CABG-related TIMI clinically significant bleeding events are sum of non CABG-related TIMI major bleeding events, TIMI minor bleeding events and TIMI bleeding events requiring medical attention. Major: any symptomatic intracranial bleeding: clinically overt signs of hemorrhage with hemoglobin (Hb) drop of greater than or equal to (>=)5 gram per deciliter (g/dl) (or absolute drop in hematocrit of >=15%) and fatal bleeding (results in death within 7 days); Minor: clinically overt sign of hemorrhage with Hb drop of 3 - <5 g/dl (or drop in hematocrit of 9 - <15%); requiring medical attention: bleeding event that required medical, surgical treatment/laboratory evaluation and did not meet criteria for major/minor bleeding event.
Time Frame
From start of study treatment until follow-up (up to 390 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants, 18 years or older, must have symptoms suggestive of acute coronary syndrome (ACS) (angina, or symptoms thought to be equivalent) within 48 hours of hospital presentation, or developed ACS while being hospitalized, and has a diagnosis of: a) ST segment elevation myocardial infarction (STEMI); b) non-ST-segment elevation acute coronary syndrome (NSTE-ACS). However, participant who is 54 years of age or younger must also have either diabetes mellitus or a history of a prior myocardial infarction (MI), in addition to the presenting ACS event Participant must be randomized within the screening window of 10 days after hospital admission for the index ACS event. Participant should have received acute phase treatment for the index ACS, such as intravenous anticoagulant or antiplatelet, and are receiving maintenance dual antiplatelet therapy (DAPT) with either clopidogrel plus acetyl salicylic acid (ASA), or ticagrelor plus ASA, with the intent to continue the treatment with a platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor) after randomization Participants must agree to provide a pharmacogenomics deoxyribonucleic acid (DNA) sample Exclusion Criteria: Participant has any conditions that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk Participant with a prior stroke of any etiology or transient ischemic attack (TIA) Participant who received thrombolytic therapy as treatment for the index ACS event cannot be enrolled in the ticagrelor stratum Participant has anticipated need for chronic administration of omeprazole or esomeprazole concomitantly with clopidogrel Participant has known allergy or intolerance to ASA or rivaroxaban
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
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Alexander City
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Banning
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Sylmar
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Aurora
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Littleton
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Brazil
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Blumenau
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Campinas
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Curitiba
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Lovech
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Pazardzhik
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Pleven
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Czechia
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France
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France
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France
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France
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France
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France
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Japan
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Kumamoto
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Japan
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Japan
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Japan
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Osaka-Shi
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Japan
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Sayama-Shi
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Japan
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Tokyo
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Japan
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Japan
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Yokohama
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Japan
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Yonago
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Japan
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Yotsui 2-8-1
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Japan
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Gwangju
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seongnam
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Korea, Republic of
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Seoul
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Suwon
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Amersfoort
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Netherlands
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Amsterdam
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Blaricum
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Den Haag
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Den Helder
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Gouda
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Groningen
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Hoofddorp
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Hoogeveen
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Nijmegen
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Rotterdam
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S-Hertogenbosch
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Schiedam
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Bielsko-Biala
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Poland
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Bytom
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Poland
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Chrzanow
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Poland
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Dabrowa Gornicza
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Poland
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Gdynia
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Poland
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Grodzisk Mazowiecki
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Poland
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Inowrocław
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Poland
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Kedzierzyn-Kozle
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Poland
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Kielce
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Poland
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Koszalin
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Krakow
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Poland
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Lodz
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Nowy Targ
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Nysa
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Poland
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Oswiecim
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Poland
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Poland
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Pulawy
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Poland
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Tychy
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Poland
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Warszawa
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Poland
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Wloclawek
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Poland
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Barnaul
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Russian Federation
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Chita
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Russian Federation
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Ekaterinburg
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Russian Federation
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Ivanovo
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Russian Federation
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Kaliningrad
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Russian Federation
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Kemerovo
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Russian Federation
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Krasnodar
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Orenburg
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Russian Federation
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Penza
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Russian Federation
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Perm
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Russian Federation
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Rostov On Don
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Russian Federation
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Saint Petersburg
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Russian Federation
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Samara
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Russian Federation
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Syktyvkar
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Russian Federation
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Tyumen
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Russian Federation
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A Coruña
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Spain
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Almería
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Murcia
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Spain
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Málaga
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Spain
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Sant Boi De Llobregat
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Spain
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Tarragona
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Spain
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Ávila
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Spain
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Falun
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Sweden
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Jönköping
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Sweden
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Linköping
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Sweden
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Lund
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Sweden
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Stockholm
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Sweden
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Sundsvall
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Sweden
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Uppsala
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Sweden
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Örebro
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Sweden
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Östersund
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Sweden
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Adana
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Turkey
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Ankara
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Turkey
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Aydin
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Turkey
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Bursa
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Turkey
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Diyarbakir
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Turkey
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Eskisehir
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Turkey
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Istanbul
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Turkey
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Kahramanmaras
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Turkey
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Kocaeli
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Turkey
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Konya
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Turkey
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Sivas
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Turkey
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Cherkasy
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Ukraine
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Dnipropetrovsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lutsk
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Ukraine
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Lviv
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Ukraine
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Odesa
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Ukraine
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Ternopil
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Ukraine
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Zaporizhzhia
Country
Ukraine
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Zhytomyr
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
31535314
Citation
Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8.
Results Reference
derived
PubMed Identifier
31141104
Citation
Povsic TJ, Ohman EM, Roe MT, White J, Rockhold FW, Montalescot G, Cornel JH, Nicolau JC, Steg PG, James S, Bode C, Welsh RC, Plotnikov AN, Mundl H, Gibson CM. P2Y12 Inhibitor Switching in Response to Routine Notification of CYP2C19 Clopidogrel Metabolizer Status Following Acute Coronary Syndromes. JAMA Cardiol. 2019 Jul 1;4(7):680-684. doi: 10.1001/jamacardio.2019.1510.
Results Reference
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PubMed Identifier
28325638
Citation
Ohman EM, Roe MT, Steg PG, James SK, Povsic TJ, White J, Rockhold F, Plotnikov A, Mundl H, Strony J, Sun X, Husted S, Tendera M, Montalescot G, Bahit MC, Ardissino D, Bueno H, Claeys MJ, Nicolau JC, Cornel JH, Goto S, Kiss RG, Guray U, Park DW, Bode C, Welsh RC, Gibson CM. Clinically significant bleeding with low-dose rivaroxaban versus aspirin, in addition to P2Y12 inhibition, in acute coronary syndromes (GEMINI-ACS-1): a double-blind, multicentre, randomised trial. Lancet. 2017 May 6;389(10081):1799-1808. doi: 10.1016/S0140-6736(17)30751-1. Epub 2017 Mar 18.
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derived
PubMed Identifier
26995378
Citation
Povsic TJ, Roe MT, Ohman EM, Steg PG, James S, Plotnikov A, Mundl H, Welsh R, Bode C, Gibson CM. A randomized trial to compare the safety of rivaroxaban vs aspirin in addition to either clopidogrel or ticagrelor in acute coronary syndrome: The design of the GEMINI-ACS-1 phase II study. Am Heart J. 2016 Apr;174:120-8. doi: 10.1016/j.ahj.2016.01.004. Epub 2016 Jan 18.
Results Reference
derived

Learn more about this trial

A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome

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