Clinical trial NCT06522113: Cilostazol and Aspirin in Stroke and TIA
Official title: Cilostazol and Aspirin in Acute Minor Stroke and Transient Ischemic Attack
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Stroke
TIA
Lead sponsor: Incheon St.Mary's Hospital
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 378
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: New stroke event for 90 days (Ischemic or hemorrhagic)
timeFrame: for 90 days
measure: Moderate-to-severe bleeding event according to (GUSTO) definition
timeFrame: for 90 days
Secondary outcomes:
measure: New clinical vascular event (ischemic or hemorrhagic stroke, myocardial infarction, or vascular death), analyzed as a composite outcome and also as individual outcomes.
timeFrame: for 90 days
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: The Catholic university of korea, Incheon St. Mary's hospital
Study officials:
affiliation: the catholic university of korea, neurology department
name: Taewon Kim, Dr
role: PRINCIPAL_INVESTIGATOR
References: