Cilostazol Stroke Prevention Study for Antiplatelet Combinatio

Phase 4

• Conditions: oncardioembolic cerebral infarction

• Registration Number: JPRN-UMIN000012180
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

The study found the risk of another ischemic stroke was halved for patients who took Pletal plus aspirin or clopidogrel, versus those who took aspirin or clopidogrel alone. Specially, 29 of 913 patients (3.2 percent) who took Pletal plus another blood thinner went on to have another stroke, compared to 64 of 926 patients (6.9 percent) who took aspirin or clopidogrel alone, the investigators found.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-31
• Study Completion: 2018-03-31
• Results First Posted: 2019-03-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 1884

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with emboligenic heart disease 2) Patients taking any anticoagulant agents 3) Patients who cannot undergo MRI examination for reasons such as claustrophobia and implanted pacemaker 4) Patients scheduled to undergo any surgery, such as percutaneous angioplasty, stent placement, and bypass grafting, during the study period 5) Patients with a drug-eluting coronary stent implanted within one year 6) Patients with a history of symptomatic non-traumatic intracranial hemorrhage, any other hemorrhagic disease (eg, active peptic ulcer), bleeding predisposition, or blood clotting disorders 7) Patients with a history of hypersensitivity to cilostazol 8) Patients with congestive heart failure or uncontrolled angina pectoris 9) Patients with thrombocytopenia (platelet count <= 100,000/mm3) 10) Patients with severe liver or renal dysfunction 11) Women who are pregnant, breast-feeding, or of child-bearing potential 12) Patients with a malignant tumor requiring treatment 13) Patients who are taking aspirin, and meet any of the following criteria: -History of hypersensitivity to aspirin or salicylic acid analogues -Current peptic ulcer -Aspirin-induced asthma or its history 14) Patients who are taking clopidogrel, and meet the following criterion: -History of hypersensitivity to clopidogrel 15) Patients who are participating in any other clinical studies 16) Patients considered by the investigator/subinvestigator to be unsuitable for participating in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified