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

Sponsor

Beijing Anzhen Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02334254

Collaborator

(none)

420

Enrollment

Location

Arms

Duration (Months)

14.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: rivaroxaban and ticagrel therapy Drug: triple antithrombotic regimen with warfarin, asipirin and clopidogrel	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

420 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2013

Anticipated Primary Completion Date :

Jan 1, 2016

Anticipated Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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.

Secondary Outcome Measures

Composite outcome of death, myocardial infarction, stent thrombosis and ischemic stroke [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

a long-term indication for oral anticoagulation treatment (until at least 1 year after the study)
a severe coronary lesion (at least 75% stenosis on angiography or fractional flow reserve lower than 0•80) with indication for PCI
age 18-80 years

Exclusion Criteria:

history of intracranial bleeding;
cardiogenic shock;
contra indication to use of antiplatelet or anticoagulation drugs;
peptic ulcer in the previous 6 months;
thrombo cytopenia (platelet concentration lower than 50~10⁹/L);
major bleeding (according to the Thrombolysis in Myocardial Infarction [TIMI] criteria) in the past 12 months; and
pregnancy.