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Completed

NCT Number: NCT00202020

Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1st affiliated hospital, Guangzhou Zhongshan University, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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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Treatment and study plan

Cilostazol 200mg/day Oral

Drug

Aspirin 100mg/day Oral

Drug

Primary outcomes

  1. Recurrence of stroke(cerebral infarction/haemorrhage/subarachnoid haemorrhage)

Secondary outcomes

  1. Recurrence of cerebral infarction detected in MRI

  2. Death due to cerebral vascular events

  3. Myocardial infarction

  4. Vascular events(acute artery thrombosis/embolism, pneumonia embolism, venous thrombosis, angina pectoris)

  5. TIA

  6. Death

Sponsors and collaborators

Lead sponsor

Otsuka Beijing Research Institute

Industry

Collaborators

  • Zhejiang Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Mar 16, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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