Cerebral InfarctionPhase 4NCT00272454
Cilostazol in Acute Ischemic Stroke Treatment (CAIST)
A Phase 4 study testing Cilostazol and Aspirin in people with Cerebral Infarction, run by Korea Otsuka Pharmaceutical Co., Ltd. at 12 sites in South Korea.
Trial summary
The purpose of this study is to study efficacy and safety of cilostazol use in patients with acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- Cilostazol and Aspirin
- How many people
- 468 participants
- Where
- 12 sitesSouth Korea
- Study dates
- Jan 2006to Sep 2008
- Phase
- Phase 4
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who receive explanation on this study and give informed consent
- Patients aged 30 to 85 years
- Baseline NIHSS less than 15
- Onset of symptoms within 48 hours of the start of investigational product
- Full functional independence prior to the present stroke indicated by an mRS score of 0, 1, 2
Who cannot join
- Evidence from CT or MRI scan of an acute intracranial hemorrhage, a tumor, encephalitis or any diagnosis other than acute ischemic stroke likely to cause the present symptoms.
- Previous regular use of an antiplatelet agent or warfarin
- Patients with known cardiac disease likely to cause cardiogenic embolism or congestive heart failure
- Evidence from CT or MRI scan of midline shift when visiting hospital
- Uncontrolled hypertension (SBP>220 mmHg or DBP>120 mmHg)
- Hypotension (<90/60 mmHg)
Show all 14Show fewer
- Patients with known bleeding diathesis or coagulation disorder
- Patients with liver disease (ALT>100 or AST>100), or renal disease (creatinine>2.0 mg/dl)
- Known severe anaemia (hemoglobin<8.0 mg/dl), or thrombocytopenia (platelet<100,000/mm3)
- Scheduled for endarterectomy within 3 months
- Severe co-morbidity likely to limit patient's life expectancy to less than 6 months
- Patients with alcohol or illegal drug abuse or dependency
- Pregnant or lactating patients. When administrating to females, it should be confirmed that the patients is in the menopause (by evaluation of investigators) or permanently infertile (hysterectomy or surgical operation like bilateral tubal ligation, bilateral oophorectomy, etc). If a patient is likely to be pregnant, the patient should not be pregnant before randomization. And, the patient should use reliable contraception between at least 3 weeks before randomization to 7 days after the final administration of study drug.
- Patients treated by thrombolytic agents like tPA after onset of stroke
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
Hallym University Sacred Heart Hospital
Ahnyang, Kyunggi Province, 431-070
Eulji University Hospital
Daejeon, 302-799
Inha University Hospital
Incheon, 400-711
Inje University Ilsan Paik Hospital
Koyang, Kyunggi Province, 411-706
Dongguk University Hospital
Koyang, Kyunggi Province
Seoul National University Hospital
Seoul, 110-799
Hallym University Kangdong Sacred Heart Hospital
Seoul, 134-701
Asan Medical Center
Seoul, 138-736
Eulji University Hospital
Seoul, 139-711
Seoul National University Boramae Hospital
Seoul, 156-707
Soonchunhyang University Hospital
Seoul
Seoul National University Bundang Hospital
Sungnam, Kyunggi Province, 463-707
About this study
Official title: The Double-Blind, Randomized, Multi-Center, and Active Controlled Trial for Efficacy and Safety of Cilostazol in Acute Ischemic Stroke
The purpose of this study is to study efficacy and safety of cilostazol use in patients with acute ischemic stroke.
Read the detailed description
Stroke is a leading cause of death and elderly disability in developed countries. However, treatment of acute stroke is limited except thrombolytic therapy in hyperacute stroke within several hours. Currently, aspirin is widely used in spite of its small benefit compared to bleeding complications.
Cilostazol will be compared to aspirin in acute stroke patients in terms of functional outcome at 3 months, efficacy to prevent stroke recurrence, and safety for bleeding complications.
- Conditions
- Cerebral Infarction
- Being tested
- Cilostazol, Aspirin
- Keywords
- cilostazol, aspirin, cerebral infarction
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CilostazolDrug
AspirinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the frequency of mRS 0, 1, 2 at 90 days
Measured: at 90 days
Secondary outcomes (7)
Frequency of mRS 0,1 at 90 days
Measured: at 90 days
Frequency of Barthel index 95-100 at 90 days
Frequency of mRS 0,1 & Barthel index 95-100 at 90 days
Frequency of NIHSS 0-1 at 90 days
Frequency of progression of neurological deficit at 7 days (increment of NIHSS 2 points or a point on the item of upper or lower extremity weakness)
Bleeding disorders (life-threatening bleeding; major bleeding; minor Bleeding)
Overall cardiovascular events (Ischemic heart disease requiring rehospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2006 (estimated)
- Study startJan 2006
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Boramae Hospital, Korea Otsuka International Asia Arab Co., Ltd.
- Investigators
- Yong-Seok Lee, M.D., PhD, Principal investigator, Department of Neurology, Seoul National University Boramae Hospital, College of Medicine, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272454
- Sponsor's protocol ID
- KOP-PLT-0501
- Status last verified
- Dec 2009
- First submitted
- 3 Jan 2006
- Last updated
- 16 Dec 2009
- Results posted
- No
Publications
Lee YS, Bae HJ, Kang DW, Lee SH, Yu K, Park JM, Cho YJ, Hong KS, Kim DE, Kwon SU, Lee KB, Rha JH, Koo J, Han MG, Lee SJ, Lee JH, Jung SW, Lee BC, Kim JS. Cilostazol in Acute Ischemic Stroke Treatment (CAIST Trial): a randomized double-blind non-inferiority trial. Cerebrovasc Dis. 2011;32(1):65-71. doi: 10.1159/000327036. Epub 2011 May 25.
PubMed 21613787
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Double-Blind, Randomized, Multi-Center, and Active Controlled Trial for Efficacy and Safety of Cilostazol in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00272454
- Acronym / sponsor ID
- KOP-PLT-0501
- Conditions
- Cerebral Infarction
- Keywords
- cilostazol, aspirin, cerebral infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 468 participants (estimated)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Boramae Hospital, Korea Otsuka International Asia Arab Co., Ltd.
- Study start
- Jan 2006
- Study completion
- Sep 2008 (actual)
- First posted
- 6 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study efficacy and safety of cilostazol use in patients with acute ischemic stroke.
Detailed description
Stroke is a leading cause of death and elderly disability in developed countries. However, treatment of acute stroke is limited except thrombolytic therapy in hyperacute stroke within several hours. Currently, aspirin is widely used in spite of its small benefit compared to bleeding complications.
Cilostazol will be compared to aspirin in acute stroke patients in terms of functional outcome at 3 months, efficacy to prevent stroke recurrence, and safety for bleeding complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who receive explanation on this study and give informed consent
- Patients aged 30 to 85 years
- Baseline NIHSS less than 15
- Onset of symptoms within 48 hours of the start of investigational product
- Full functional independence prior to the present stroke indicated by an mRS score of 0, 1, 2
Key exclusion criteria (14 listed)
- Evidence from CT or MRI scan of an acute intracranial hemorrhage, a tumor, encephalitis or any diagnosis other than acute ischemic stroke likely to cause the present symptoms.
- Previous regular use of an antiplatelet agent or warfarin
- Patients with known cardiac disease likely to cause cardiogenic embolism or congestive heart failure
- Evidence from CT or MRI scan of midline shift when visiting hospital
- Uncontrolled hypertension (SBP>220 mmHg or DBP>120 mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cilostazol | Drug | – |
| Aspirin | Drug | – |
Primary outcome
Comparison of the frequency of mRS 0, 1, 2 at 90 days
Time frame: at 90 days
7 secondary outcomes
Frequency of mRS 0,1 at 90 days
Time frame: at 90 days
Frequency of Barthel index 95-100 at 90 days
Frequency of mRS 0,1 & Barthel index 95-100 at 90 days
Frequency of NIHSS 0-1 at 90 days
Frequency of progression of neurological deficit at 7 days (increment of NIHSS 2 points or a point on the item of upper or lower extremity weakness)
Bleeding disorders (life-threatening bleeding; major bleeding; minor Bleeding)
Overall cardiovascular events (Ischemic heart disease requiring rehospitalization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2009.
- Derived from this study: PubMed 21613787Lee YS, Bae HJ, Kang DW, Lee SH, Yu K, Park JM, Cho YJ, Hong KS, Kim DE, Kwon SU, Lee KB, Rha JH, Koo J, Han MG, Lee SJ, Lee JH, Jung SW, Lee BC, Kim JS. Cilostazol in Acute Ischemic Stroke Treatment (CAIST Trial): a randomized double-blind non-inferiority trial. Cerebrovasc Dis. 2011;32(1):65-71. doi: 10.1159/000327036. Epub 2011 May 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong-Seok Lee, M.D., PhD principal investigator
Department of Neurology, Seoul National University Boramae Hospital, College of Medicine, Seoul National University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cilostazol and Aspirin in people with Cerebral Infarction, run by Korea Otsuka Pharmaceutical Co., Ltd. at 12 sites in South Korea.
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 5 inclusion and 14 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 Dec 2009. 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Comparison of the frequency of mRS 0, 1, 2 at 90 days (time frame: at 90 days). 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 NCT00272454, which also lists 1 linked publication.
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 Dec 2009.