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

Last updated: December 23, 2024
Sponsor: National Hospital Organization Osaka National Hospital
Overall Status: Terminated

Phase

4

Condition

Dysrhythmia

Blood Clots

Cerebral Ischemia

Treatment

Oral Anticoagulant

Antiplatelet Drug

Clinical Study ID

NCT03062319
ATIS-NVAF
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with an acute ischemic stroke or TIA from 8 days and up to 360 days fromthe onset of symptoms

  2. Age 20 or older

  3. Patients with non-valvular atrial fibrillation (chronic or paroxysmal) who start orcontinue taking an oral anticoagulant

  4. Patients who have one of the following atherothrombotic diseases

  5. A past history of ischemic heart disease (myocardial infarction, anginapectoris, coronary artery bypass graft (CABG), percutaneous coronaryintervention (PCI)

  6. A past history of peripheral artery disease (symptomatic peripheral arterialocclusive disease, lower extremity bypass surgery/angioplasty/stenting)

  7. Carotid artery stenosis (symptomatic or asymptomatic (=>50% diameter), ahistory of carotid artery stenting (CAS) or carotid endarterectomy (CEA))

  8. Intracranial artery stenosis (=>50% stenosis of the diameter of a majorintracranial artery: intracranial internal carotid artery, anterior cerebralartery (ACA)-A1 and A2, middle cerebral artery (MCA)-M1 and M2, posteriorcerebral artery (PCA)-P1 and P2, vertebral artery, and basilar artery; ahistory of intracranial stent placement or intracranial bypass surgery)

  9. A past history of atherothrombotic brain infarction, lacunar infarction, orbranch atheromatous disease

  10. Patients without severe disability (modified Rankin Scale score =<4)

  11. Patients who can take oral medications

  12. Patients who can receive follow-up survey

  13. Provision of written informed consent either directly or by a suitable surrogate

Exclusion

Exclusion Criteria:

  1. History of myocardial infarction or acute coronary syndrome within the past 12months

  2. Patients who underwent PCI with drug-eluting stents within the past 12 months or PCIwith 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. History of symptomatic intracranial hemorrhage or gastrointestinal bleeding withinthe past 6 months

  5. Hemorrhagic diathesis or blood coagulation disorders

  6. Platelet counts <100,000 /mm3 at enrollment.

  7. Severe anemia (hemoglobin <7 g/dL)

  8. Severe renal failure (creatinine clearance =<15 mL/min) or undergoing chronichemodialysis.

  9. Severe liver dysfunction (Grade B or C of the Child-Pugh classification)

  10. Patients with severe disability requires constant nursing care, bedridden (modifiedRankin Scale score =5)

  11. Pregnant or possibly pregnant women

  12. Active cancer

  13. Expectation of survival less than 2 years

  14. Anticoagulant or antiplatelet is scheduled to be discontinued for more than 4 weeksduring the follow-up period

  15. 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

Study Design

Total Participants: 321
Treatment Group(s): 2
Primary Treatment: Oral Anticoagulant
Phase: 4
Study Start date:
April 06, 2017
Estimated Completion Date:
July 18, 2023

Study 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.

Connect with a study center

  • Kobe City Medical Center General Hospital

    Kobe, Hyogo 650-0047
    Japan

    Site Not Available

  • National Cerebral and Cardiovascular Center

    Suita, Osaka 565-8565
    Japan

    Site Not Available

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006
    Japan

    Site Not Available

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