Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke

Condition(s) targeted: Cerebral Infarction

Intervention: Cilostazol 200mg/day Oral (Drug); Aspirin 100mg/day Oral (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Otsuka Beijing Research Institute

Official(s) and/or principal investigator(s):
Yi N Huang, Professor, Principal Investigator, Affiliation: Peking University First Hospital

The study design is subject to relevant SFDA regulations about clinical trials. This indication was approved in Japan in 2003.

From the end of May 2004 to the end of Dec. 2004, 720 patients with previous cerebral infarction(see the inclusion criteria) were enrolled in to the study and received one of the two treatment regimens, Cilostazol or Aspirin, the ratio of patient number of each group is 1: 1. For each patient, the chance of entering either of these two groups is the same. The treatment will continue till the end of 2005. During the treatment period, patients will be observed concerning some certain events, mainly reoccurrence of stroke. If the patient experiences reoccurrence of stroke, or other event that the doctors think it is not appropriate to continue the study medication, this patient would stop the treatment. Patients were also required to take MRI head scan before entering the study and on completion of the treatment.

Official title: Cilostazol Stroke Prevention Study-a Randomized, Double Blind, Double Dummy, Parallel Comparative, Multicenter Clinical Trial

Study design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Recurrence of stroke(cerebral infarction/haemorrhage/subarachnoid haemorrhage)

Secondary outcome:

Recurrence of cerebral infarction detected in MRI

Death due to cerebral vascular events

Myocardial infarction

Vascular events(acute artery thrombosis/embolism, pneumonia embolism, venous thrombosis, angina pectoris)

TIA

Death

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Patients who had cerebral infarction within 6 months and 1 month before entry 2. Within a few days of the onset of cerebral infarction onset, CT or MRI showed evidence of infarction that could be responsible for this stroke onset 3. A modified ranking scale of less than 4 4. Aged 18~75 5. Consent of the patients or their legal guardians

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Exclusion Criteria:

1. History of intracranial hemorrhage 2. Stroke secondary to cardiogenic embolism 3. Serious damage of motorial function, dementia 4. Serious complications or co morbidity(uncontrolled accelerated type of hypertension, BP>180/120mmHg, diabetic acidosis, heart failure, renal failure, hepatocirrhosis, malignant tumor) 5. Contraindication of Cilostazol and Aspirin 6. Patients who need co medication of other antiplatelet agents, anticoagulants or fibrinolytic drugs 7. Active peptic ulcer 8. Pregnancy or breast feeding

9. Judged to be inappropriate to enter the study by investigators. -

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1st affiliated hospital, Peking University, Beijing, China

Huashan Hospital Shanghai Fudan University, Shanghai, China

General Hospital of Beijing Military Area of PLA, Beijing, China

General Hospital, Tianjin Medical University, Tianjin, China

Renji Hospital, Shanghai 2nd medical university, Shanghai, China

Renmin Hospital, Peking University, Beijing, China

3rd affiliated hospital, Peking University, Beijing, China

1st affiliated hospital, Guangzhou Zhongshan University, Guangzhou, Guangdong, China

2nd affiliated hospital, Guangzhou medical college, Guangzhou, Guangdong, China

1st affiliated Jilin University, Changchun, Jilin, China

1st affiliated hospital, Xi'an Jiatong University, Xi'an, Shanxi, China

2nd affiliated hospital, Zhejiang University, Hangzhou, Zhejiang, China

Starting date: May 2004
Ending date: January 2006
Last updated: March 15, 2006