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

Beijing Anzhen Hospital420 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

420

Conditions

Atrial Fibrillation

Interventions

rivaroxaban and ticagrel therapyDRUG

Antiplatelet therapy are mandatory at least 1 month after bare metal stent implantation, and 6 months after drug-eluting stent implantation.

triple antithrombotic regimen with warfarin, asipirin and clopidogrelDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Anzhen Hospital,Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

Composite outcome of death, myocardial infarction, stent thrombosis and ischemic stroke

Time frame: 12 months

Central Contacts

Yujie Zhou, MD

CONTACT

86 18610323937 yjzhou.az@gmail.com

Fei Gao, MD

CONTACT

1-347-257-4916 fgaomd@163.com

Data from ClinicalTrials.gov

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