Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke

Last updated: March 15, 2006
Sponsor: Otsuka Beijing Research Institute
Overall Status: Completed

Phase

3

Condition

Stroke

Cerebral Ischemia

Occlusions

Treatment

N/A

Clinical Study ID

NCT00202020
OBRI0001
  • Ages 18-75
  • All Genders

Study 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

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. History of intracranial hemorrhage 2. Stroke secondary to cardiogenic embolism 3.Serious damage of motorial function, dementia 4. Serious complications or comorbidity(uncontrolled accelerated type of hypertension, BP>180/120mmHg, diabetic acidosis,heart failure, renal failure, hepatocirrhosis, malignant tumor) 5. Contraindication ofCilostazol 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
  2. Judged to be inappropriate to enter the study by investigators. -

Study Design

Total Participants: 720
Study Start date:
May 01, 2004
Estimated Completion Date:
January 31, 2006

Connect with a study center

  • 1st affiliated hospital, Guangzhou Zhongshan University

    Guangzhou, Guangdong
    China

    Site Not Available

  • 2nd affiliated hospital, Guangzhou medical college

    Guangzhou, Guangdong
    China

    Site Not Available

  • 1st affiliated Jilin University

    Changchun, Jilin
    China

    Site Not Available

  • 1st affiliated hospital, Xi'an Jiatong University

    Xi'an, Shanxi
    China

    Site Not Available

  • 2nd affiliated hospital, Zhejiang University

    Hangzhou, Zhejiang
    China

    Site Not Available

  • 1st affiliated hospital, Peking University

    Beijing,
    China

    Site Not Available

  • 3rd affiliated hospital, Peking University

    Beijing,
    China

    Site Not Available

  • General Hospital of Beijing Military Area of PLA

    Beijing,
    China

    Site Not Available

  • Renmin Hospital, Peking University

    Beijing,
    China

    Site Not Available

  • Huashan Hospital Shanghai Fudan University

    Shanghai,
    China

    Site Not Available

  • Renji Hospital, Shanghai 2nd medical university

    Shanghai,
    China

    Site Not Available

  • General Hospital, Tianjin Medical University

    Tianjin,
    China

    Site Not Available

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