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

Atrial Fibrillation Clinical Trial

— ATIS-NVAF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03062319
• Other study ID #: ATIS-NVAF
• Status: Recruiting
• Phase: Phase 4
• Start date: April 6, 2017
• Est. completion date: April 30, 2026

Study information

• Verified date: October 2020
• Source: National Hospital Organization Osaka National Hospital
• Contact: Hiroshi Yamagami, MD
• Phone: +81-6-6942-1331
• Email: yamagami-brain[@]umin.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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:

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

Related Conditions & MeSH terms

• Atherothrombosis
• Atrial Fibrillation
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Oral Anticoagulant
warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban
• Antiplatelet Drug
aspirin, clopidogrel, prasugrel, ticlopidine, or cilostazol

Locations

Country	Name	City	State
Japan	Kobe City Medical Center General Hospital	Kobe	Hyogo
Japan	National Hospital Organization Osaka National Hospital	Osaka

Sponsors (3)

Lead Sponsor	Collaborator
National Hospital Organization Osaka National Hospital	Network for Clinical Stroke Trials, The BMS/Pfizer Japan Thrombosis Investigator Initiated Research Program

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years after randomization
Secondary	All-cause mortality	All-cause mortality	2 years after randomization
Secondary	Ischemic cardiovascular events	Ischemic cardiovascular events (cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, ischemic events requiring urgent revascularization)	2 years after randomization
Secondary	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)	2 years after randomization
Secondary	Ischemic stroke	Ischemic stroke	2 years after randomization
Secondary	Myocardial infarction and cardiovascular death	Myocardial infarction and cardiovascular death	2 years after randomization
Secondary	major bleeding	major bleeding defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria	2 years after randomization
Secondary	Intracranial hemorrhage	Intracranial hemorrhage	2 years after randomization