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Cerebral InfarctionPhase 3NCT00202020

Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke

A Phase 3 study testing Cilostazol 200mg/day Oral and Aspirin 100mg/day Oral in people with Cerebral Infarction, run by Otsuka Beijing Research Institute at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cerebral Infarction
What is being tested?
Cilostazol 200mg/day Oral and Aspirin 100mg/day Oral
Type of treatment
Pill or oral medicine
How many people
720 participants
Where
12 sitesChina
Study dates
May 2004to Jan 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • -

Who cannot join

  • 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. -
  • -

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • 1st affiliated hospital, Peking University

    Beijing

  • 3rd affiliated hospital, Peking University

    Beijing

  • General Hospital of Beijing Military Area of PLA

    Beijing

  • Renmin Hospital, Peking University

    Beijing

  • 1st affiliated Jilin University

    Changchun, Jilin

  • 1st affiliated hospital, Guangzhou Zhongshan University

    Guangzhou, Guangdong

  • 2nd affiliated hospital, Guangzhou medical college

    Guangzhou, Guangdong

  • 2nd affiliated hospital, Zhejiang University

    Hangzhou, Zhejiang

  • Huashan Hospital Shanghai Fudan University

    Shanghai

  • Renji Hospital, Shanghai 2nd medical university

    Shanghai

  • General Hospital, Tianjin Medical University

    Tianjin

  • 1st affiliated hospital, Xi'an Jiatong University

    Xi’an, Shanxi

Other trials in China

About this study

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

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.

Being tested
Cilostazol 200mg/day Oral, Aspirin 100mg/day Oral
Keywords
Cerebral infarction, Prevention, Cilostazol, Aspirin, Stroke, Clinical trial
Medical subject headings
Cerebral Infarction, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cilostazol 200mg/day OralDrug

  • Aspirin 100mg/day OralDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startMay 2004
  3. Study completionJan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
720 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00202020
Sponsor's protocol ID
OBRI0001
Status last verified
Mar 2006
First submitted
12 Sep 2005
Last updated
16 Mar 2006
Results posted
No

Publications

  • 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.

    PubMed 22949472

  • 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.

    PubMed 18456558

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cilostazol 200mg/day Oral and Aspirin 100mg/day Oral in people with Cerebral Infarction, run by Otsuka Beijing Research Institute at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence of stroke(cerebral infarction/haemorrhage/subarachnoid haemorrhage). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00202020, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2006.

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