Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke

NCT00202020 | Completed Phase 3

• 1 other identifier: OBRI0001
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 12

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

Keywords

Cerebral infarction; Prevention; Cilostazol; Aspirin; Stroke; Clinical trial

Outcome Measures

Primary Outcomes (1)

• Recurrence of stroke(cerebral infarction/haemorrhage/subarachnoid haemorrhage)

Secondary Outcomes (6)

• 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

Interventions

Cilostazol 200mg/day Oral DRUG

Aspirin 100mg/day Oral DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• \. 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. -

Sponsors & Collaborators

• Otsuka Beijing Research Institute: lead
• Zhejiang Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (12)

1st affiliated hospital, Guangzhou Zhongshan University

Guangzhou, Guangdong, China

Location

2nd affiliated hospital, Guangzhou medical college

Guangzhou, Guangdong, China

Location

1st affiliated Jilin University

Changchun, Jilin, China

Location

1st affiliated hospital, Xi'an Jiatong University

Xi’an, Shanxi, China

Location

2nd affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, China

Location

1st affiliated hospital, Peking University

Beijing, China

Location

3rd affiliated hospital, Peking University

Beijing, China

Location

General Hospital of Beijing Military Area of PLA

Beijing, China

Location

Renmin Hospital, Peking University

Beijing, China

Location

Huashan Hospital Shanghai Fudan University

Shanghai, China

Location

Renji Hospital, Shanghai 2nd medical university

Shanghai, China

Location

General Hospital, Tianjin Medical University

Tianjin, China

Location

Related Publications (2)

• 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.

  PMID: 22949472 DERIVED

• 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.

  PMID: 18456558 DERIVED

MeSH Terms

Conditions

Cerebral Infarction; Stroke

Interventions

Cilostazol; Aspirin

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Yi N Huang, Professor

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: May 1, 2004
• Study Completion: January 1, 2006
• Last Updated: March 16, 2006

Record last verified: 2006-03

Locations

CN (12)