Clinical trial NCT00202020: Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke
Official title: Cilostazol Stroke Prevention Study-a Randomized, Double Blind, Double Dummy, Parallel Comparative, Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebral Infarction
Keywords: Cerebral infarction
Prevention
Cilostazol
Aspirin
Stroke
Clinical trial
Lead sponsor: Otsuka Beijing Research Institute
Sponsor class: INDUSTRY
Collaborators: name: Zhejiang Otsuka Pharmaceutical Co., Ltd.
First posted: 2005-09-20
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

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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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Primary outcomes:
measure: Recurrence of stroke(cerebral infarction/haemorrhage/subarachnoid haemorrhage)
Secondary outcomes:
measure: Recurrence of cerebral infarction detected in MRI
measure: Death due to cerebral vascular events
measure: Myocardial infarction
measure: Vascular events(acute artery thrombosis/embolism, pneumonia embolism, venous thrombosis, angina pectoris)
measure: TIA
measure: Death
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: 1st affiliated hospital, Guangzhou Zhongshan University
state: Guangdong
city: Guangzhou
country: China
facility: 2nd affiliated hospital, Guangzhou medical college
state: Guangdong
city: Changchun
country: China
facility: 1st affiliated Jilin University
state: Jilin
city: Xi'an
country: China
facility: 1st affiliated hospital, Xi'an Jiatong University
state: Shanxi
city: Hangzhou
country: China
facility: 2nd affiliated hospital, Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: 1st affiliated hospital, Peking University
city: Beijing
country: China
facility: 3rd affiliated hospital, Peking University
city: Beijing
country: China
facility: General Hospital of Beijing Military Area of PLA
city: Beijing
country: China
facility: Renmin Hospital, Peking University
city: Shanghai
country: China
facility: Huashan Hospital Shanghai Fudan University
city: Shanghai
country: China
facility: Renji Hospital, Shanghai 2nd medical university
city: Tianjin
country: China
facility: General Hospital, Tianjin Medical University
Study officials:
affiliation: Peking University First Hospital
name: Yi N Huang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.