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Clinical Trial Summary

The Purpose of this open-label randomized controlled multicenter trial is to evaluate the efficacy and safety of mono-drug therapy with oral anticoagulant compared to combination therapy with antiplatelet drug, in ischemic stroke patients with non-valvular atrial fibrillation and atherothrombosis.


Clinical Trial Description

The Purpose of this open-label randomized controlled multicenter trial is to evaluate the efficacy and safety of mono-drug therapy with oral anticoagulant compared to combination therapy with antiplatelet drug, in ischemic stroke patients with non-valvular atrial fibrillation and atherothrombosis. Target sample size is 400. The primary outcome is a composite endpoint of ischemic cardiovascular events (cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, ischemic events requiring urgent revascularization) and major bleeding defined by the International Society on Thrombosis and Haemostasis(ISTH) criteria within 2 years after randomization. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03062319
Study type Interventional
Source National Hospital Organization Osaka National Hospital
Contact Hiroshi Yamagami, MD
Phone +81-6-6942-1331
Email yamagami-brain@umin.ac.jp
Status Recruiting
Phase Phase 4
Start date April 6, 2017
Completion date April 30, 2026

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