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

Capital Medical University

Status and phase: Unknown; Phase 4

Conditions: Atrial Fibrillation

Treatments: Drug: rivaroxaban and ticagrel therapy; Drug: triple antithrombotic regimen with warfarin, asipirin and clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT02334254

anzhen2013009

Details and patient eligibility

About

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).

Full 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.

Enrollment: 420 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 2 patient groups

Dual antithrombotic therapy (DAT)

Experimental group

Description:

Dual Antithrombotic Therapy (DAT) regimen of rivaroxaban 2.5mg/5mg b.i.d. plus ticagrelor 90mg b.i.d.

Treatment:

Drug: rivaroxaban and ticagrel therapy

Triple antithrombotic therapy (TAT)

Active Comparator group

Description:

Triple antithrombotic therapy (TAT) regimen of aspirin 100mg q.d., clopidogrel 75mg q.d. plus warfarin (INR 1.8-2.5).

Treatment:

Drug: triple antithrombotic regimen with warfarin, asipirin and clopidogrel