Cilostazol and Aspirin in Stroke and TIA

NCT06522113 | Completed Phase 4

• 1 other identifier: OC23RISI0149
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; TIA

Outcome Measures

Primary Outcomes (2)

• New stroke event for 90 days (Ischemic or hemorrhagic)

  New stroke event for 90 days (Ischemic or hemorrhagic)

  for 90 days

• Moderate-to-severe bleeding event according to (GUSTO) definition

  Moderate-to-severe bleeding event according to (GUSTO) definition: Moderate : bleeding requiring transfusion Severe : Fatal or intracerebral bleeding, or bleeding resulting in substantial hemodynamic compromise requiring treatment

  for 90 days

Secondary Outcomes (1)

• New clinical vascular event (ischemic or hemorrhagic stroke, myocardial infarction, or vascular death), analyzed as a composite outcome and also as individual outcomes.

  for 90 days

Study Arms (2)

aspirin with clopidogrel

ACTIVE COMPARATOR

aspirin 100mg with clopidogrel 75mg for 21 days

Drug: Clopidogrel

aspirin with cilostazol

EXPERIMENTAL

aspirin 100mg with cilostazol 200 mg for 21 days

Drug: Cilostazol

Interventions

Cilostazol DRUG

patients were given cilostazol 100mg twice a day with aspirin

Also known as: aspirin

aspirin with cilostazol

Clopidogrel DRUG

patients were given clopidogrel 75mg with aspirin

Also known as: aspirin

aspirin with clopidogrel

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Incheon St.Mary's Hospital: lead

Study Sites (1)

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

Incheon, South Korea

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Cilostazol; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines

Study Officials

• Taewon Kim, Dr

  the catholic university of korea, neurology department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: July 18, 2019
• Primary Completion: October 17, 2022
• Study Completion: October 17, 2022
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

KR (1)