NCT02334254

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This is an open-label (both physician and participant know the treatment that the participant receives), randomized (study medication is assigned by chance), multicenter clinical study assessing the safety of the combination of rivaroxaban and ticagrel versus triple antithrombotic regimen (warfarin, clopigogrel and aspirin) in patients, who have paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and concomitant coronary artery disease undergoing percutaneous coronary intervention (PCI). A target of 420 participants will be randomized into the study, with approximately 210 participants in each treatment strategy group. Primary comparisons will be made of the rates of major and clinically relevant bleeding, assessed by the modified International Society of Thrombosis and Haemostasis (ISTH) classification. The study consists of a screening phase, a 12-month open-label treatment phase, and an end-of-treatment/early withdrawal visit. The total duration of participation in the study for each participant is approximately 12 months.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
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.
DRUG	triple antithrombotic regimen with warfarin, asipirin and clopidogrel

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2015-01-08
• Last updated: 2015-01-08

Locations

1 site across 1 country: China