Cilostazol and Aspirin in Stroke and TIA

Cilostazol and Aspirin in Acute Minor Stroke and Transient Ischemic Attack

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke; TIA
• Intervention / Treatment: Drug: Clopidogrel; Drug: Cilostazol

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.

• Study Type: Interventional
• Enrollment (Actual): 378
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • The Catholic University of Korea, Incheon St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: aspirin with clopidogrel; aspirin 100mg with clopidogrel 75mg for 21 days	Drug: Clopidogrel; patients were given clopidogrel 75mg with aspirin; Other Names: aspirin
Experimental: aspirin with cilostazol; aspirin 100mg with cilostazol 200 mg for 21 days	Drug: Cilostazol; patients were given cilostazol 100mg twice a day with aspirin; Other Names: aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
New clinical vascular event (ischemic or hemorrhagic stroke, myocardial infarction, or vascular death), analyzed as a composite outcome and also as individual outcomes.	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.	for 90 days

Collaborators and Investigators

• Sponsor: Incheon St.Mary's Hospital
• Investigators: Principal Investigator: Taewon Kim, Dr, the catholic university of korea, neurology department

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2019
• Primary Completion (Actual): October 17, 2022
• Study Completion (Actual): October 17, 2022

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neuroprotective Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Aspirin; Clopidogrel; Cilostazol
• Other Study ID Numbers: OC23RISI0149

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No