drugset / Trial / NCT01962545

Optimizing Antithrombotic Care in Patients With AtriaL fibrillatiON and Coronary stEnt (OAC-ALONE) Study

NCT01962545 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to evaluate non-inferiority of oral anticoagulant (OAC) monotherapy to OAC plus single antiplatelet therapy (APT) in patients with atrial fibrillation (AF) and prior (\>12 months) coronary stenting.

Timeline

Start
2013-11-05
Primary completion
2017-05-18
Completion
2018-05-18

Outcome

Missed primary endpoint

paper This randomized trial did not establish noninferiority of OAC alone to combined OAC and APT in patients with atrial fibrillation and stable coronary artery disease beyond 1 year after stenting. PMID 30586700 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 81 mg —
Subject Aspirin Small molecule 324 mg —
Subject Clopidogrel Small molecule 75 mg —
Background Apixaban Small molecule 2.5 mg Oral
Background Apixaban Small molecule 5 mg Oral
Background Dabigatran Unknown 110 mg Oral
Background Dabigatran Unknown 150 mg Oral
Background Edoxaban Small molecule 30 mg Oral
Background Edoxaban Small molecule 60 mg Oral
Background Rivaroxaban Other / unclassified 10 mg Oral
Background Rivaroxaban Other / unclassified 15 mg Oral
Background Warfarin Small molecule — Oral