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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: rivaroxaban and ticagrel therapy
* Drug: triple antithrombotic regimen with warfarin, asipirin and clopidogrel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dual antithrombotic therapy (DAT)<br>Dual Antithrombotic Therapy (DAT) regimen of rivaroxaban 2.5mg/5mg b.i.d. plus ticagrelor 90mg b.i.d. | Drug: rivaroxaban and ticagrel therapy<br>* Antiplatelet therapy are mandatory at least 1 month after bare metal stent implantation, and 6 months after drug-eluting stent implantation.<br>|
| Active Comparator: Triple antithrombotic therapy (TAT)<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major or clinically relevant non-major bleeding | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite outcome of death, myocardial infarction, stent thrombosis and ischemic stroke |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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undergoing PCI, safety, rivaroxaban, ticagrel, triple antithrombotic regimen