Rivaroxaban in Patients With Atrial Fibrillation and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention

NCT02334254 Phase 4 UNKNOWN

To evaluate the safety for the combination of Rivaroxaban and Ticagrel versus triple antithrombotic regimen (Vitamin K Antagonist (VKA), Clopigogrel and Aspirin) in patients with atrial fibrillation and coronary artery disease undergoing percutaneous coronary intervention (PCI).

Details

Lead sponsor	Beijing Anzhen Hospital
Phase	Phase 4
Status	UNKNOWN
Enrolment	420
Start date	2013-08
Completion	2016-01

Conditions

• Atrial Fibrillation

Interventions

• rivaroxaban and ticagrel therapy
• triple antithrombotic regimen with warfarin, asipirin and clopidogrel

Primary outcomes

• Major or clinically relevant non-major bleeding — 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.

Countries

China