NCT04023630

DUAL Antithrombotic Therapy in Patients With AF and ACS

An Open-label, Randomized, Controlled, Multicenter Study to Evaluate DUAL Antithrombotic Therapy With Rivaroxaban Plus Ticagrelor vs. Rivaroxaban Plus Clopidogrel in Patients With Atrial Fibrillation and Acute Coronary Syndrome

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4,000 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The study aims to show inferiority of rivaroxaban plus ticagrelor when compared to rivaroxaban plus clopidogrel in terms of safety. Safety will be determined by comparing the rates of death or ischemic event-including myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization.

Detailed description

The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of rivaroxaban plus ticagrelor with rivaroxaban plus clopidogrel in Patients With Non Valvular Atrial Fibrillation (NVAF) and Acute Coronary Syndrome. The study aims to show inferiority of rivaroxaban plus ticagrelor when compared to rivaroxaban plus clopidogrel in terms of safety. Safety will be determined by comparing the rates of death or ischemic event-including myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization.

Conditions

• Atrial Fibrillation
• Acute Coronary Syndromes

Interventions

Type	Name	Description
DRUG	Rivaroxaban 15 MG Oral Tablet	One 15 mg tablet once daily for up to twelve months
DRUG	Clopidogrel 75 Mg Oral Tablet	One 75 mg tablet once daily for up to twelve months
DRUG	Ticagrelor 90 MG Oral Tablet	One 90 mg tablet twice daily for up to twelve months

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-09-30
• Completion: 2021-09-30
• First posted: 2019-07-17
• Last updated: 2019-07-17