Trial | NCT03062319  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    400
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.
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 Started
Apr 06
2017
Primary Completion
Apr 30
2022
Anticipated
Study Completion
Apr 30
2026
Anticipated
Last Update
Oct 12
2020

Drug Oral Anticoagulant [warfarin (coumadin), dabigatran (pradaxa), rivaroxaban (xarelto), apixaban (eliquis), edoxaban (savaysa)]

warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban

Drug Antiplatelet Drug [acetylsalicylic acid (aspirin), clopidogrel (plavix), prasugrel (effient), ticlopidine (ticlid), cilostazol (pletal)]

aspirin, clopidogrel, prasugrel, ticlopidine, or cilostazol

Dual-therapy group Active Comparator

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.

Single-therapy group Active Comparator

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.

Criteria 

Inclusion Criteria:

Patients with an acute ischemic stroke or TIA from 8 days and up to 360 days from the onset of symptoms
Age 20 or older
Patients with non-valvular atrial fibrillation (chronic or paroxysmal) who start or continue taking an oral anticoagulant

Patients who have one of the following atherothrombotic diseases

A past history of ischemic heart disease (myocardial infarction, angina pectoris, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI)
A past history of peripheral artery disease (symptomatic peripheral arterial occlusive disease, lower extremity bypass surgery/angioplasty/stenting)
Carotid artery stenosis (symptomatic or asymptomatic (=>50% diameter), a history of carotid artery stenting (CAS) or carotid endarterectomy (CEA))
Intracranial artery stenosis (=>50% stenosis of the diameter of a major intracranial artery: intracranial internal carotid artery, anterior cerebral artery (ACA)-A1 and A2, middle cerebral artery (MCA)-M1 and M2, posterior cerebral artery (PCA)-P1 and P2, vertebral artery, and basilar artery; a history of intracranial stent placement or intracranial bypass surgery)
A past history of atherothrombotic brain infarction, lacunar infarction, or branch atheromatous disease
Patients without severe disability (modified Rankin Scale score =<4)
Patients who can take oral medications
Patients who can receive follow-up survey
Provision of written informed consent either directly or by a suitable surrogate

Exclusion Criteria:

History of myocardial infarction or acute coronary syndrome within the past 12 months
Patients who underwent PCI with drug-eluting stents within the past 12 months or PCI with bare-metal stents within the past 3 months
Patients who underwent carotid artery stent placement, intracranial stent placement, or lower extremity stent placement within the past 3 months
History of symptomatic intracranial hemorrhage or gastrointestinal bleeding within the past 6 months
Hemorrhagic diathesis or blood coagulation disorders
Platelet counts <100,000 /mm3 at enrollment.
Severe anemia (hemoglobin <7 g/dL)
Severe renal failure (creatinine clearance =<15 mL/min) or undergoing chronic hemodialysis.
Severe liver dysfunction (Grade B or C of the Child-Pugh classification)
Patients with severe disability requires constant nursing care, bedridden (modified Rankin Scale score =5)
Pregnant or possibly pregnant women
Active cancer
Expectation of survival less than 2 years
Anticoagulant or antiplatelet is scheduled to be discontinued for more than 4 weeks during the follow-up period
Planned revascularization procedure during the follow-up period
Patients who are enrolled in other trials
Patients judged as inappropriate for this study by investigators
No Results Posted