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
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
3 other identifiers
interventional
3,037
20 countries
259
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 \[NSTE-ACS\]).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2015
Shorter than P25 for phase_2
259 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2014
CompletedFirst Posted
Study publicly available on registry
November 18, 2014
CompletedStudy Start
First participant enrolled
April 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 14, 2016
CompletedResults Posted
Study results publicly available
November 13, 2017
CompletedDecember 26, 2017
November 1, 2017
1.5 years
November 13, 2014
October 11, 2017
November 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From start of study treatment until follow-up (up to 390 days)
Study Arms (4)
Stratum 1/ASA
ACTIVE COMPARATORAcetylsalicylic 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.
Stratum 1/Rivaroxaban
EXPERIMENTALRivaroxaban 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.
Stratum 2/ASA
ACTIVE COMPARATORASA 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.
Stratum 2/Rivaroxaban
EXPERIMENTALRivaroxaban 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.
Interventions
ASA 100 mg enteric-coated tablet once daily orally.
Rivaroxaban 2.5 mg tablet twice daily orally.
Clopidogrel 75 mg once daily orally.
Ticagrelor 90 mg twice daily orally.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Research & Development, LLClead
- Bayercollaborator
- Duke Clinical Research Institutecollaborator
- Harvard Medical School (HMS and HSDM)collaborator
Study Sites (259)
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Alexander City, Alabama, United States
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Banning, California, United States
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Sylmar, California, United States
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Aurora, Colorado, United States
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Littleton, Colorado, United States
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Jupiter, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Pensacola, Florida, United States
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Tampa, Florida, United States
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Athens, Georgia, United States
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Cumming, Georgia, United States
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Macon, Georgia, United States
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Tucker, Georgia, United States
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Boise, Idaho, United States
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Coeur d'Alene, Idaho, United States
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Jerseyville, Illinois, United States
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Indianapolis, Indiana, United States
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Munster, Indiana, United States
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Bay City, Michigan, United States
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Kalamazoo, Michigan, United States
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Lansing, Michigan, United States
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Mount Clemens, Michigan, United States
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Ypsilanti, Michigan, United States
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Minneapolis, Minnesota, United States
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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Kalispell, Montana, United States
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Stony Brook, New York, United States
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Rocky Mount, North Carolina, United States
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Sanford, North Carolina, United States
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Cincinnati, Ohio, United States
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Zanesville, Ohio, United States
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Bartlesville, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Abington, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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York, Pennsylvania, United States
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Rapid City, South Dakota, United States
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Oak Ridge, Tennessee, United States
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Amarillo, Texas, United States
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Fort Sam Houston, Texas, United States
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Houston, Texas, United States
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Odessa, Texas, United States
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San Antonio, Texas, United States
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Danville, Virginia, United States
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Puyallup, Washington, United States
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Buenos Aires, Argentina
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Caba, Argentina
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Ciudad de Buenos Aires, Argentina
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Cordooba, Argentina
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Corrientes, Argentina
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Córdoba, Argentina
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La Plata, Argentina
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Mar del Plata, Argentina
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Resistencia, Argentina
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Rosario, Argentina
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Salta, Argentina
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San Martín, Argentina
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Santa Fe, Argentina
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Brisbane, Australia
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Cairns, Australia
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Chermside, Australia
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Elizabeth Vale, Australia
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Herston, Australia
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Hobart, Australia
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Launceston, Australia
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Liverpool, Australia
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Murdoch, Australia
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Nambour, Australia
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New Lambton Heights, Australia
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Antwerp, Belgium
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Bonheiden, Belgium
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Brasschaat, Belgium
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Bruges, Belgium
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Edegem, Belgium
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Genk, Belgium
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Ghent, Belgium
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Huy, Belgium
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Liège, Belgium
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Mol, Belgium
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Roeselare, Belgium
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Ronse, Belgium
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Turnhout, Belgium
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Belo Horizonte, Brazil
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Blumenau, Brazil
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Campina Grande do Sul, Brazil
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Campinas, Brazil
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Curitiba, Brazil
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Marília, Brazil
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Passo Fundo, Brazil
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Porto Alegre, Brazil
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Recife, Brazil
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Salvador, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
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Tatuí, Brazil
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Uberlândia, Brazil
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Votuporanga, Brazil
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Blagoevgrad, Bulgaria
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Burgas, Bulgaria
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Haskovo, Bulgaria
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Lovech, Bulgaria
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Pazardzhik, Bulgaria
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Pleven, Bulgaria
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Rousse, Bulgaria
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Sandanski, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Edmonton, Alberta, Canada
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New West Minister, British Columbia, Canada
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Victoria, British Columbia, Canada
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Greater Sudbury, Ontario, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Québec, Canada
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Brno, Czechia
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Kolin Iii., Czechia
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Ostrava, Czechia
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Plzen-Bory, Czechia
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Prague, Czechia
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Třebíč, Czechia
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Znojmo, Czechia
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Herlev, Denmark
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Køge, Denmark
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Silkeborg, Denmark
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Besançon, France
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Chambray-lès-Tours, France
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Jossigny, France
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Le Coudray, France
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Lyon, France
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Montauban, France
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Nantes, France
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Périgueux, France
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Balatonfüred, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Győr, Hungary
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Gyula, Hungary
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Kaposvár, Hungary
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Kecskemét, Hungary
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Nyíregyháza, Hungary
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Székesfehérvár, Hungary
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Szolnok, Hungary
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Gifu, Japan
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Kagawa, Japan
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Kitakyushu, Japan
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Kobe, Japan
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Kumamoto, Japan
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Matsue, Japan
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Nagano, Japan
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Osaka, Japan
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Sayama-Shi, Japan
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Tokyo, Japan
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Uwajima-Shi, Japan
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Yokohama, Japan
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Yonago, Japan
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Yotsui 2-8-1, Japan
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's-Hertogenbosch, Netherlands
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Amersfoort, Netherlands
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Amsterdam, Netherlands
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Blaricum, Netherlands
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Den Helder, Netherlands
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Gouda, Netherlands
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Groningen, Netherlands
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Hoofddorp, Netherlands
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Hoogeveen, Netherlands
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Nijmegen, Netherlands
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Rotterdam, Netherlands
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Schiedam, Netherlands
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The Hague, Netherlands
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Bielsko-Biala, Poland
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Bytom, Poland
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Chrzanów, Poland
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Dąbrowa Górnicza, Poland
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Gdynia, Poland
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Grodzisk Mazowiecki, Poland
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Inowrocław, Poland
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Kędzierzyn-Koźle, Poland
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Kielce, Poland
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Koszalin, Poland
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Krakow, Poland
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Lodz, Poland
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Nowy Targ, Poland
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Nysa, Poland
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Oświęcim, Poland
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Polanica-Zdrój, Poland
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Puławy, Poland
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Tychy, Poland
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Warsaw, Poland
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Włocławek, Poland
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Barnaul, Russia
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Chita, Russia
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Ivanovo, Russia
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Kaliningrad, Russia
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Kemerovo, Russia
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Krasnodar, Russia
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Krasnoyarsk, Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Orenburg, Russia
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Penza, Russia
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Perm, Russia
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Rostov-on-Don, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Syktyvkar, Russia
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Tyumen, Russia
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Yekaterinburg, Russia
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Gwangju, South Korea
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Incheon, South Korea
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Seongnam, South Korea
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Seoul, South Korea
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Suwon, South Korea
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A Coruña, Spain
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Almería, Spain
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Ávila, Spain
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Barcelona, Spain
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Madrid, Spain
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Málaga, Spain
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Murcia, Spain
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Sant Boi de Llobregat, Spain
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Tarragona, Spain
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Falun, Sweden
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Jönköping, Sweden
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Linköping, Sweden
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Lund, Sweden
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Örebro, Sweden
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Östersund, Sweden
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Stockholm, Sweden
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Sundsvall, Sweden
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Uppsala, Sweden
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Adana, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Aydin, Turkey (Türkiye)
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Bursa, Turkey (Türkiye)
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Diyarbakır, Turkey (Türkiye)
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Eskişehir, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Kahramanmaraş, Turkey (Türkiye)
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Kocaeli, Turkey (Türkiye)
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Konya, Turkey (Türkiye)
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Sivas, Turkey (Türkiye)
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Cherkasy, Ukraine
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Dnipropetrovsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Lutsk, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Ternopil, Ukraine
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Zaporizhzhia, Ukraine
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Zhytomyr, Ukraine
Related Publications (4)
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.
PMID: 31535314DERIVEDPovsic 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.
PMID: 31141104DERIVEDOhman 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.
PMID: 28325638DERIVEDPovsic 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.
PMID: 26995378DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study population was homogenous with limited participation of non-Caucasian participants. Randomization was not performed for use of P2Y12 inhibitor; strata comparisons between bleeding and efficacy endpoints are confounded and were not planned.
Results Point of Contact
- Title
- Associate Director
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2014
First Posted
November 18, 2014
Study Start
April 20, 2015
Primary Completion
October 14, 2016
Study Completion
October 14, 2016
Last Updated
December 26, 2017
Results First Posted
November 13, 2017
Record last verified: 2017-11