Cilostazol and Aspirin in Stroke and TIA

NCT ID: NCT06522113

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 378 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-18
• Study Completion Date: 2022-10-17

Brief Summary

This study is a randomized, open-labelled trial. We randomly assigned patients within 24 hours after the onset of minor ischemic stroke or high-risk TIA to combination therapy with cilostazol and aspirin or to clopidogrel plus aspirin. The primary outcome was stroke (ischemic or hemorrhagic) during 90 days of follow-up in an intention-to-treat analysis.

Detailed Description

This study is a randomized, open-labelled trial. We randomly assigned patients within 24 hours after the onset of minor ischemic stroke or high-risk TIA to combination therapy with cilostazol and aspirin (aspirin 100mg with cilostazol 200 mg for 21 days) or to clopidogrel plus aspirin (aspirin 100mg with clopidogrel 75mg for 21 days). The primary outcome was stroke (ischemic or hemorrhagic) during 90 days of follow-up in an intention-to-treat analysis. The primary safety outcome was the moderate-to-severe bleeding event according to (GUSTO) definition. The secondary outcomes were new clinical vascular event (ischemic or hemorrhagic stroke, myocardial infarction, or vascular death), analyzed as a composite outcome and also as individual outcomes. Vascular death was defined as death due to stroke (ischemic or hemorrhagic), systemic hemorrhage, myocardial infarction, congestive heart failure, pulmonary embolism, sudden death, or arrhythmia.

Conditions

Ischemic Stroke; TIA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

aspirin with clopidogrel

aspirin 100mg with clopidogrel 75mg for 21 days

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

patients were given clopidogrel 75mg with aspirin

aspirin with cilostazol

aspirin 100mg with cilostazol 200 mg for 21 days

Group Type: EXPERIMENTAL

Cilostazol

Intervention Type: DRUG

patients were given cilostazol 100mg twice a day with aspirin

Interventions

Cilostazol

patients were given cilostazol 100mg twice a day with aspirin

Intervention Type: DRUG

Clopidogrel

patients were given clopidogrel 75mg with aspirin

Intervention Type: DRUG

Other Intervention Names

aspirin; aspirin

Eligibility Criteria

Inclusion Criteria

• Diagnosis of an acute minor ischemic stroke or TIA
• Acute minor stroke was defined by a score of 3 or less at the time of randomization on the National Institutes of Health Stroke Scale (NIHSS; scores range from 0 to 42, with higher scores indicating greater deficits)

Exclusion Criteria

• Intracerebral Hemorrhage
• Brain tumor
• Brain abscess, or other major non-ischemic brain disease;
• Isolated sensory symptoms (numbness, isolated visual changes, or isolated dizziness or vertigo) without evidence of acute infarction on baseline CT or MRI of the head
• A score of more than 2 on the modified Rankin scale, immediately before the occurrence of the index ischemic stroke or TIA, indicating moderate disability or worse at baseline
• An NIHSS score of 4 or more at randomization
• A clear indication for anticoagulation therapy (presumed cardiac source of embolus, such as atrial fibrillation or prosthetic cardiac valve) or a contraindication to clopidogrel, cilostazol or aspirin
• History of intracranial hemorrhage
• Anticipated requirement for long-term non-study antiplatelet drugs or for nonsteroidal anti-inflammatory drugs affecting platelet function
• Heparin therapy or oral anticoagulation therapy within 10 days before randomization
• Gastrointestinal bleeding or major surgery within the previous 3 months
• Planned or probable revascularization (any angioplasty or vascular surgery) within 3 months after screening (if clinically indicated, vascular imaging was to be performed before randomization, whenever possible)
• Planned surgery or interventional treatment requiring cessation of the study drug
• TIA or minor stroke caused by angiography or surgery
• Severe non- cardiovascular coexisting condition, with a life expectancy of less than 3 months

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incheon St.Mary's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Taewon Kim

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Taewon Kim, Dr

Role: PRINCIPAL_INVESTIGATOR

the catholic university of korea, neurology department

Locations

The Catholic university of korea, Incheon St. Mary's hospital

Incheon, , South Korea

Countries

South Korea

Other Identifiers

OC23RISI0149

Identifier Type: -

Identifier Source: org_study_id