Randamized clinical trial of reduction in the recurrence of acute noncardioembolic stroke by Cilostazol and Eicosapentaneic acid for hypercholesterolemic patients

Phase 3

• Conditions: on-cardioembolic cerebral infarction

• Registration Number: JPRN-UMIN000013864
• Lead Sponsor: Department of Neurology, Tokyo Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-01
• Study Completion: 2015-03-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Patients with a history of acute myocardial infarction within six months Patients with congestive heart failure or uncontrolled angina pectoris Patients with a history of caridiovascular angioplasty within six months Patients with severe liver or renal dysfunction Patients with a malignant tumor requiring treatment Patients with uncontrolled diabetes mellitus Patients with secondary dyslipidemia (due to corticosteroid etc) Patients with hemorrhagic diseases (eg. Hemophilia, hemorrhagic intestinal diseases, hemorrhage from gastrointesitinal tract and urinary tract, hemoptysis) Patients with hypersensitivity to aspirin, clopidogrel or cilostazol Patients scheduled to undergo any surgery during the study period Patients considered by the investigator/subinvestigator to be unsuitable for participating in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of symptomatic ischemic stroke, with the symptoms lasting for at least 24 hours

Secondary Outcome Measures

Name	Time	Method
Any stroke [ischemic stroke (IS), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH)] IS or transient ischemic attack (TIA) ICH or SAH Death from any cause Stroke (IS, ICH, SAH), myocardial infarction (MI), or vascular events All vascular events: stroke, MI, and other vascular events Adverse events and adverse drug reactions Severe or life-threatening hemorrhage (GUSTO Criteria)