Rivaroxaban in Patients With Atrial Fibrillation and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02334254|
Recruitment Status : Unknown
Verified January 2015 by Yujie Zhou, Beijing Anzhen Hospital.
Recruitment status was: Recruiting
First Posted : January 8, 2015
Last Update Posted : January 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: rivaroxaban and ticagrel therapy Drug: triple antithrombotic regimen with warfarin, asipirin and clopidogrel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||420 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rivaroxaban in Patients With Atrial Fibrillation and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||January 2016|
Experimental: Dual antithrombotic therapy (DAT)
Dual Antithrombotic Therapy (DAT) regimen of rivaroxaban 2.5mg/5mg b.i.d. plus ticagrelor 90mg b.i.d.
Drug: rivaroxaban and ticagrel therapy
Antiplatelet therapy are mandatory at least 1 month after bare metal stent implantation, and 6 months after drug-eluting stent implantation.
Active Comparator: Triple antithrombotic therapy (TAT)
Triple antithrombotic therapy (TAT) regimen of aspirin 100mg q.d., clopidogrel 75mg q.d. plus warfarin (INR 1.8-2.5).
Drug: triple antithrombotic regimen with warfarin, asipirin and clopidogrel
- Major or clinically relevant non-major bleeding [ Time Frame: 12 months ]Major bleeding was assessed by the International Society of Thrombosis and Hemostasis (ISTH) definition. It included bleeding that was fatal, occurred in a critical location (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, intramuscular with compartment syndrome, or pericardial), or was associated with a fall in hemoglobin of 2 g/dL or a transfusion of 2 units of packed red blood cells. Clinically relevant non-major bleeding was defined as bleeding that required medical or surgical intervention.
- Composite outcome of death, myocardial infarction, stent thrombosis and ischemic stroke [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334254
|Contact: Yujie Zhou, MD||86 firstname.lastname@example.org|
|Contact: Fei Gao, MDemail@example.com|
|Beijing Anzhen Hospital,Capital Medical University||Recruiting|
|Beijing, Beijing, China, 100029|
|Contact: Fei Gao, MD 1-347-257-4916 firstname.lastname@example.org|
|Contact: Hua Shen, MD 86 13718667442 email@example.com|
|Principal Investigator:||Yujie Zhou, MD||Beijing Anzhen Hospital|