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

NCT03062319

Last updated date
Study Location
Kobe City Medical Center General Hospital
Kobe, Hyogo, 650-0047, Japan
Contact
+81-6-6833-5012

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ischemic Stroke, Atrial Fibrillation, Atherothrombosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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 who can walk independently (modified Rankin Scale score =<3)

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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 who are unable to walk independently (modified Rankin Scale score =>4)


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

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Ischemic Stroke, Atrial Fibrillation, AtherothrombosisOptimal Antithrombotic Therapy in Ischemic Stroke Patients With Non-Valvular Atrial Fibrillation and Atherothrombosis
NCT03062319
  1. Kobe, Hyogo
  2. Suita, Osaka
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Optimal Antithrombotic Therapy in Ischemic Stroke Patients With Non-Valvular Atrial Fibrillation and Atherothrombosis
Official Title  ICMJE Optimal Antithrombotic Therapy in Ischemic Stroke Patients With Non-Valvular Atrial Fibrillation and Atherothrombosis
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Ischemic Stroke
  • Atrial Fibrillation
  • Atherothrombosis
Intervention  ICMJE
  • Drug: Oral Anticoagulant
    warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban
  • Drug: Antiplatelet Drug
    aspirin, clopidogrel, prasugrel, ticlopidine, or cilostazol
Study Arms  ICMJE
  • 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.
    Interventions:
    • 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.
    Intervention: Drug: Oral Anticoagulant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 19, 2017)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 who can walk independently (modified Rankin Scale score =<3)
  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:

  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 who are unable to walk independently (modified Rankin Scale score =>4)
  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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hiroshi Yamagami, MD+81-6-6833-5012 ext 8025[email protected]
Contact: Shuhei Okazaki, MD+81-6-6833-5012 ext 8123[email protected]
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03062319
Other Study ID Numbers  ICMJE ATIS-NVAF
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Undecided
Responsible Party Hiroshi Yamagami, National Cerebral and Cardiovascular Center
Study Sponsor  ICMJE National Cerebral and Cardiovascular Center
Collaborators  ICMJE
  • Network for Clinical Stroke Trials
  • The BMS/Pfizer Japan Thrombosis Investigator Initiated Research Program
Investigators  ICMJE
Principal Investigator:Hiroshi Yamagami, MDNational Cerebral and Cardiovascular Center
PRS Account National Cerebral and Cardiovascular Center
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP