Cilostazol and Aspirin in Stroke and TIA

Last updated: August 2, 2024
Sponsor: Incheon St.Mary's Hospital
Overall Status: Completed

Phase

4

Condition

Stroke

Cerebral Ischemia

Blood Clots

Treatment

Cilostazol

Clopidogrel

Clinical Study ID

NCT06522113
OC23RISI0149
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 randomizationon the National Institutes of Health Stroke Scale (NIHSS; scores range from 0 to 42,with higher scores indicating greater deficits)

Exclusion

Exclusion Criteria:

  • Intracerebral Hemorrhage

  • Brain tumor

  • Brain abscess, or other major non-ischemic brain disease;

  • Isolated sensory symptoms (numbness, isolated visual changes, or isolated dizzinessor 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 theoccurrence of the index ischemic stroke or TIA, indicating moderate disability orworse 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 toclopidogrel, cilostazol or aspirin

  • History of intracranial hemorrhage

  • Anticipated requirement for long-term non-study antiplatelet drugs or fornonsteroidal 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 3months after screening (if clinically indicated, vascular imaging was to beperformed 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

Study Design

Total Participants: 378
Treatment Group(s): 2
Primary Treatment: Cilostazol
Phase: 4
Study Start date:
July 18, 2019
Estimated Completion Date:
October 17, 2022

Study 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.

Connect with a study center

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

    Incheon,
    Korea, Republic of

    Site Not Available

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