Optimal Antithrombotic Therapy in Ischemic Stroke Patients with Non-Valvular Atrial Fibrillation and Atherothrombosis (ATIS-NVAF)

JRCT ID: jRCTs051180202

Registered date:27/03/2019

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Ischemic Stroke
• Date of first enrollment: 08/05/2017
• Target sample size: 400
• Study type: Interventional

Intervention(s)

Dual-therapy group:
single anticoagulant drug (warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban) and single antiplatelet drug (aspirin, clopidogrel, prasgrel, ticlopidine, or cilostazol). The dosage is determined according to each drug's package insert in Japan.
Single-therapy group:
Single anticoagulant drug (warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban). The dosage is determined according to eachdrug's package insert in Japan.

Outcome(s)

Primary Outcome

Composite endpoint of ischemic cardiovascular events and major bleeding.
One of the following ischemic cardiovascular events (cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, or ischemic events requiring urgent revascularization), or major bleeding defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria.
[Time Frame: 2 years after randomization]

Secondary Outcome

1.All-cause mortality [Time Frame: 2 years after randomization]
2.Ischemic cardiovascular events (cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism,ischemic events requiring urgent revascularization) [Time Frame: 2 years after randomization]
3.All ischemic cardiovascular events including transient ischemia (cardiovascular death, ischemic stroke, transient ischemic attack (TIA), myocardial infarction, unstable angina pectoris, systemic embolism, progression of symptomatic peripheral artery disease, ischemic events requiring urgent revascularization) [Time Frame: 2 years after randomization]
4.Ischemic stroke [Time Frame: 2 years after randomization]
5.Myocardial infarction and cardiovascular death [Time Frame: 2 years after randomization]
6.Major bleeding defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria [Time Frame: 2 years after randomization]
7.Intracranial hemorrhage [Time Frame: 2 years after randomization]

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients with an acute ischemic stroke or TIA from 15 days and up to 180 days from the onset of symptoms
2. Age 20 or older
3. Patients with nonvalvular atrial fibrillation (chronic or paroxysmal) who start or continue taking an oral anticoagulant
4. Patients who have one of the following atherothrombotic diseases
(1) A past history of ischemic heart disease, myocardial infarction, angina pectoris, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI)
(2) A past history of peripheral artery disease (symptomatic peripheral arterial occlusive disease, lower extremity bypass surgery/angioplasty/stenting)
(3) Carotid artery stenosis (symptomatic or asymptomatic (=>50% diameter), a history of carotid artery stenting (CAS) or carotid endarterectomy (CEA)
(4) 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)
(5) A past history of atherothrombotic brain infarction, lacunar infarction, or branch atheromatous disease
5. Patients without severe disability (modified Rankin Scale score =<4)
6. Patients who can take oral medications
7. Patients who can receive follow up survey
8. Provision of written informed

Exclude criteria

1.Patients with a history of myocardial infarction or acute coronary syndrome within the past 12 months
2.Patients who underwent PCI with drug-eluting stents within the past 12 months or PCI with bare-metal stents within the past 3 months
3.Patients who underwent carotid artery stent placement, intracranial stent placement, or lower extremity stent placement within the past 3 months
4.Patients with a history of symptomatic intracranial hemorrhage or gastrointestinal bleeding within the past 6 months
5.Patients with hemorrhagic diathesis or blood coagulation disorders
6.Patients with platelet counts <100,000 /m m3 at enrollment.
7.Patients with severe anemia (hemoglobin <7 g/dL)
8.Patients with severe renal failure (creatinine clearance =<15 mL/min) or who are undergoing chronic hemodialysis.
9.Patients with severe liver dysfunction (Grade B or C of the Child-Pugh classification)
10.Patients with severe disability requires constant nursing care, bedridden (modified Rankin Scale score =5)
11.Pregnant or possibly pregnant women
12.Patients with active cancer
13.Patients with expectation of survival less than 2 years
14.Patients in whom anticoagulant or antiplatelet is scheduled to be discontinued for more than 4 weeks during the follow-up period
15.Patients with a planned revascularization procedure during the follow-up period
16.Patients who are enrolled in other trials
17.Patients judged as inappropriate for this study by investigators

Related Information

• Primary Sponsor: Yamagami Hiroshi
• Source(s) of Monetary Support: Bristol-Myers Squibb Company
• Secondary ID(s): UMIN000025392, NCT03062319