Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

March 15, 2006

Start Date ^ICMJE

May 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00202020 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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
Death

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cerebral Infarction

Intervention ^ICMJE

Drug: Cilostazol 200mg/day Oral
Drug: Aspirin 100mg/day Oral

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

720

Completion Date

January 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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. -

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00202020

Responsible Party

Study ID Numbers ^ICMJE

OBRI0001

Study Sponsor ^ICMJE

Otsuka Beijing Research Institute

Collaborators ^ICMJE

Zhejiang Otsuka Pharmaceutical Co., Ltd.

Investigators ^ICMJE

Principal Investigator:

Yi N Huang, Professor

Peking University First Hospital

Information Provided By

Otsuka Beijing Research Institute

Verification Date

March 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP