Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke

Cerebral Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00202020
• Other study ID #: OBRI0001
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: March 15, 2006
• Start date: May 2004
• Est. completion date: January 2006

Study information

• Verified date: March 2006
• Source: Otsuka Beijing Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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. -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Intervention

Drug:
• Cilostazol 200mg/day Oral

• Aspirin 100mg/day Oral

Locations

Country	Name	City	State
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	1st affiliated Jilin University	Changchun	Jilin
China	1st affiliated hospital, Guangzhou Zhongshan University	Guangzhou	Guangdong
China	2nd affiliated hospital, Guangzhou medical college	Guangzhou	Guangdong
China	2nd affiliated hospital, Zhejiang University	Hangzhou	Zhejiang
China	Huashan Hospital Shanghai Fudan University	Shanghai
China	Renji Hospital, Shanghai 2nd medical university	Shanghai
China	General Hospital, Tianjin Medical University	Tianjin
China	1st affiliated hospital, Xi'an Jiatong University	Xi'an	Shanxi

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Beijing Research Institute	Zhejiang Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of stroke(cerebral infarction/haemorrhage/subarachnoid haemorrhage)
Secondary	Recurrence of cerebral infarction detected in MRI
Secondary	Death due to cerebral vascular events
Secondary	Myocardial infarction
Secondary	Vascular events(acute artery thrombosis/embolism, pneumonia embolism, venous thrombosis, angina pectoris)
Secondary	TIA
Secondary	Death