Optimal Antithrombotic Therapy in Ischemic Stroke Patients With Non-Valvular Atrial Fibrillation and Atherothrombosis "ATIS-NVAF"

Recruiting

Phase 4 Results N/A

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.

Detailed 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.

Conditions

Interventions

  • Oral Anticoagulant Drug
    Intervention Desc: warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban
    ARM 1: Kind: Experimental
    Label: Dual-therapy group
    Description: Dual-therapy group: single anticoagulant drug and single antiplatelet drug. The dosage is determined according to each drug's package insert in Japan. In patients treated with warfarin, the target international normalized ratio (INR) range of 2.0-3.0 for those <70 years and 1.6-2.6 for those =>70 years is recommended according to the Japanese guidelines.
    ARM 2: Kind: Experimental
    Label: Single-therapy group
    Description: Single-therapy group: single anticoagulant drug. The dosage is determined according to each drug's package insert in Japan. In patients treated with warfarin, the target international normalized ratio (INR) range of 2.0-3.0 for those <70 years and 1.6-2.6 for those =>70 years is recommended according to the Japanese guidelines.
  • Antiplatelet Drug Drug
    Intervention Desc: aspirin, clopidogrel, prasugrel, ticlopidine, or cilostazol
    ARM 1: Kind: Experimental
    Label: Dual-therapy group
    Description: Dual-therapy group: single anticoagulant drug and single antiplatelet drug. The dosage is determined according to each drug's package insert in Japan. In patients treated with warfarin, the target international normalized ratio (INR) range of 2.0-3.0 for those <70 years and 1.6-2.6 for those =>70 years is recommended according to the Japanese guidelines.

Outcomes

Type Measure Time Frame Safety Issue
Primary Composite endpoint of ischemic cardiovascular events and major bleeding 2 years after randomization
Secondary All-cause mortality 2 years after randomization
Secondary Ischemic cardiovascular events 2 years after randomization
Secondary All ischemic cardiovascular events including transient ischemia 2 years after randomization
Secondary Ischemic stroke 2 years after randomization
Secondary Myocardial infarction and cardiovascular death 2 years after randomization
Secondary major bleeding 2 years after randomization
Secondary Intracranial hemorrhage 2 years after randomization

Sponsors