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TerminatedNCT03062319ATIS-NVAFUpdated Dec 27, 2024

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

A Phase 4 interventional study of Oral Anticoagulant and Antiplatelet Drug in Ischemic Stroke, Atrial Fibrillation and Atherothrombosis, sponsored by National Hospital Organization Osaka National Hospital. Terminated at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by National Hospital Organization Osaka National Hospital · Phase 4, Interventional, and Prevention

Why this study was terminated
The trial was terminated at the planned interim analysis for futility on July 18, 2023.
Phase
Phase 4
Study type
Interventional
Enrollment
321
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Ischemic Stroke
  • Atrial Fibrillation
  • Atherothrombosis

Keywords

  • anticoagulant
  • antiplatelet
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 321 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

This is the only study on the registry with National Hospital Organization Osaka National Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with an acute ischemic stroke or TIA from 8 days and up to 360 days from the onset of symptoms
  2. Age 20 or older
  3. Patients with non-valvular 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 consent either directly or by a suitable surrogate

Exclusion criteria

Exclusion Criteria:

  1. 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. History of symptomatic intracranial hemorrhage or gastrointestinal bleeding within the 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 chronic hemodialysis.
  9. 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. Active cancer
  13. Expectation of survival less than 2 years
  14. Anticoagulant or antiplatelet is scheduled to be discontinued for more than 4 weeks during 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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
321 participants (actual)

Study arms

  • Active comparator
    Dual-therapy group

    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.

    Drug: Oral Anticoagulant · Drug: Antiplatelet Drug

  • Active comparator
    Single-therapy group

    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.

    Drug: Oral Anticoagulant

Interventions

  • DrugOral Anticoagulant

    warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban

  • DrugAntiplatelet Drug

    aspirin, clopidogrel, prasugrel, ticlopidine, or cilostazol

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. All-cause mortality

    All-cause mortality

    Time frame: 2 years after randomization

  2. Ischemic cardiovascular events

    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

    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

    Ischemic stroke

    Time frame: 2 years after randomization

  5. Myocardial infarction and cardiovascular death

    Myocardial infarction and cardiovascular death

    Time frame: 2 years after randomization

  6. major bleeding

    major bleeding defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria

    Time frame: 2 years after randomization

  7. Intracranial hemorrhage

    Intracranial hemorrhage

    Time frame: 2 years after randomization

07

Study locations

1 site
  • National Hospital Organization Osaka National Hospital
    Osaka, 540-0006, Japan
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03062319
Lead sponsor
National Hospital Organization Osaka National Hospital
Collaborators
Network for Clinical Stroke Trials, The BMS/Pfizer Japan Thrombosis Investigator Initiated Research Program
Responsible party
Hiroshi Yamagami (Director, Department of Stroke Neurology, National Hospital Organization Osaka National Hospital) — Principal investigator
First posted
Feb 23, 2017
Start date
Apr 6, 2017
Primary completion
Jul 18, 2023
Completion
Jul 18, 2023
Last update
Dec 27, 2024

Study contacts

Hiroshi Yamagami, MD
principal investigator · National Hospital Organization Osaka National Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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