Cilostazol and Aspirin in Stroke and TIA

Incheon St.Mary's Hospital

Status and phase

Completed

Phase 4

Conditions

TIA

Ischemic Stroke

Treatments

Drug: Clopidogrel

Drug: Cilostazol

Study type

Interventional

Funder types

Other

Identifiers

NCT06522113

OC23RISI0149

Details and patient eligibility

About

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.

Full 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.

Enrollment

378 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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