Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke

NCT ID: NCT00202020

Last Updated: 2006-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2006-01-31

Brief Summary

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.

Conditions

Cerebral Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Cilostazol 200mg/day Oral

Intervention Type: DRUG

Aspirin 100mg/day Oral

Intervention Type: DRUG

Eligibility 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

-

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. -

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Otsuka Beijing Research Institute

INDUSTRY

Sponsor Role: lead

Principal Investigators

Yi N Huang, Professor

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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

1st affiliated hospital, Peking University

Beijing, , China

3rd affiliated hospital, Peking University

Beijing, , China

General Hospital of Beijing Military Area of PLA

Beijing, , China

Renmin Hospital, Peking University

Beijing, , China

Huashan Hospital Shanghai Fudan University

Shanghai, , China

Renji Hospital, Shanghai 2nd medical university

Shanghai, , China

General Hospital, Tianjin Medical University

Tianjin, , China

Countries

China

References

Liu W, Liu R, Sun W, Peng Q, Zhang W, Xu E, Cheng Y, Ding M, Li Y, Hong Z, Wu J, Zeng J, Yao C, Huang Y; CASISP Study Group. Different impacts of blood pressure variability on the progression of cerebral microbleeds and white matter lesions. Stroke. 2012 Nov;43(11):2916-22. doi: 10.1161/STROKEAHA.112.658369. Epub 2012 Sep 4.

Reference Type: DERIVED

PMID: 22949472 (View on PubMed)

Huang Y, Cheng Y, Wu J, Li Y, Xu E, Hong Z, Li Z, Zhang W, Ding M, Gao X, Fan D, Zeng J, Wong K, Lu C, Xiao J, Yao C; Cilostazol versus Aspirin for Secondary Ischaemic Stroke Prevention cooperation investigators. Cilostazol as an alternative to aspirin after ischaemic stroke: a randomised, double-blind, pilot study. Lancet Neurol. 2008 Jun;7(6):494-9. doi: 10.1016/S1474-4422(08)70094-2. Epub 2008 May 2.

Reference Type: DERIVED

PMID: 18456558 (View on PubMed)

Other Identifiers

OBRI0001

Identifier Type: -

Identifier Source: org_study_id