Cerebral InfarctionPhase 4ARCCNCT00446641
Overcome Biochemical Aspirin Resistance Through Cilostazol Combination
A Phase 4 study testing Cilostazol in people with Cerebral Infarction, run by Asan Medical Center at 4 sites in South Korea.
Trial summary
This study will recruit 316 ischemic stroke patients taking aspirin. They will be randomly assigned into cilostazol group or placebo group. Every patients will take 200mg of cilostazol a day or placebo for 1 month. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- Cilostazol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 244 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Mar 2007to Jul 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic cerebral infarction documented on MRI or CT
- More than 35 years of age
- Patients taking aspirin 100mg a day for 2 weeks or more before randomization
Who cannot join
- Patients taking any antiplatelets other than aspirin within 2 weeks before randomization
- Patients taking any anticoagulants within 2 weeks before randomization
- Patients taking thrombolytic therapy within 2 weeks before randomization
- Patients taking any NSAIDs within 2 weeks before randomization
- Patients who need to take NSAIDs regularly (e.g. rheumatic arthritis).
- Bleeding diathesis
Show all 12Show fewer
- Chronic liver disease (ALT > 100 or AST > 100) or chronic renal disease (creatinine > 3.0mg/dl)
- Anemia (hemoglobin < 10mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3)
- Pregnant or lactating patients
- Patients scheduled for angioplasty or revascularization procedures within 4 weeks
- Patients scheduled for any surgery or invasive procedures within 4 weeks
- Patients having acute coronary syndrome
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Jae-Kwan Cha
Busan, Busan, 602-715
Eulji University Hospital
Daejeon, 302-799
Kangdong Sacred Heart Hospital, Hallym University
Seoul, 134-701
Asan Medical Center
Seoul, 138-736
About this study
Official title: Phase 4 Study of Additional Cilostazol for Overcoming Biochemical Aspirin Resistance in the Chronic Stroke Patients
This study will recruit 316 ischemic stroke patients taking aspirin.
They will be randomly assigned into cilostazol group or placebo group. Every patients will take 200mg of cilostazol a day or placebo for 1 month.
The primary outcome variable of this study is rate of biochemical aspirin resistance on the Ultra Rapid Platelet Function Assay-ASA.
Read the detailed description
[Goal] To reveal the effect and safety of additional cilostazol for overcoming biochemical aspirin resistance.
[Trial Design] Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial
[Participants] Ischemic stroke patients taking aspirin
[Methods]
- Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial
- Investigational product: Cilostazol 200mg (100mg twice per day)
- Concomitant medication: Aspirin 100 mg per day
- Medication Duration: 1 month
[Outcome Variables]
Primary Outcome Variable:
- the proportion of patients with aspirin reaction units (ARUs) values ≥550 on the Ultra Rapid Platelet Function Assay-ASA
Secondary outcome variables:
- the proportion of patients with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA
- ARUs values
- Bleeding time (BT)
- Fatal or major bleeding complications
- Any bleeding complications
- Conditions
- Cerebral Infarction
- Being tested
- Cilostazol, placebo
- Keywords
- Infarction, Cerebral, Cilostazol, Aspirin Resistance
- 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
Also called pletaal
cilostazol 100mg twice a day for 4 weeks
placeboDrug
Also called matching placebo of cilostazol
placebo 1 tablet twice a day matching for cilostazol
| Study group | Role | What they receive |
|---|---|---|
| 1 Cilostazol | Experimental | 100mg of Cilostazol twice a day Receives: Drug: Cilostazol |
| Placebo | Placebo comparator | matching placebo to cilostazol Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aspirin Resistance (ARU ≥ 550)
The number of patients with aspirin reaction units (ARUs) values ≥ 550 on the Ultra Rapid Platelet Function Assay-ASA among the recruited patients
Measured: 4 weeks after treatment
Secondary outcomes (6)
Aspirin Resistance (ARU ≥ 500)
The number of participants with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA; ARUs values
Measured: 4 weeks after reatment
Bleeding Time (BT)
for evaluation of the extent of the bleeding time prolongation by additional cilostazol
Measured: 4 weeks after reatment
Fatal or Major Bleeding Complications;
Fatal or life-threatening bleeding was defined as any fatal bleeding event, a drop in hemoglobin of ≥ 50g/L, or significant hypotension with need for inotropic agents, symptomatic intracranial hemorrhage, or transfusion of ≥ 4 units of red-blood cells or equivalent amount of whole blood. Major bleeding was defined as significantly disabling bleedings, intraocular bleeding leading to significant visual loss, or bleeding requiring transfusion of ≤ 3 units of red-blood cells or equivalent amount of whole blood
Measured: events ocurred during study medication after randomization
Any Bleeding Complications
any bleeding events causing medical attention
Measured: events ocurred during study medication after randomization
Difference of Post-treatment ARU and Baseline ARU
summation of change of ARU (posttreatment ARU - baseline ARU) of individual patients
Measured: baseline ARU measured at the randomization and post-treatment ARU measured at the 4weeks treatment with study medication
Post-treatment ARU
mean of ARU value of individual participants after 4 weeks treatment
Measured: after 4 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
- Investigators
- Sun U Kwon, MD. PhD., Principal investigator, Asan Medical Center, Univsersity of Ulsan, Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446641
- Sponsor's protocol ID
- ARCC
- Acronym
- ARCC
- Status last verified
- Nov 2009
- First submitted
- 12 Mar 2007
- Last updated
- 18 Jan 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Additional Cilostazol for Overcoming Biochemical Aspirin Resistance in the Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT00446641
- Acronym / sponsor ID
- ARCC / ARCC
- Conditions
- Cerebral Infarction
- Keywords
- Infarction, Cerebral, Cilostazol, Aspirin Resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
- Study start
- Mar 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 13 Mar 2007 (estimated)
- Results
- Posted 18 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will recruit 316 ischemic stroke patients taking aspirin.
They will be randomly assigned into cilostazol group or placebo group. Every patients will take 200mg of cilostazol a day or placebo for 1 month.
The primary outcome variable of this study is rate of biochemical aspirin resistance on the Ultra Rapid Platelet Function Assay-ASA.
Detailed description
[Goal] To reveal the effect and safety of additional cilostazol for overcoming biochemical aspirin resistance.
[Trial Design] Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial
[Participants] Ischemic stroke patients taking aspirin
[Methods]
- Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial
- Investigational product: Cilostazol 200mg (100mg twice per day)
- Concomitant medication: Aspirin 100 mg per day
- Medication Duration: 1 month
[Outcome Variables]
Primary Outcome Variable:
- the proportion of patients with aspirin reaction units (ARUs) values ≥550 on the Ultra Rapid Platelet Function Assay-ASA
Secondary outcome variables:
- the proportion of patients with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA
- ARUs values
- Bleeding time (BT)
- Fatal or major bleeding complications
- Any bleeding complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Cilostazol | Experimental | Drug: Cilostazol100mg of Cilostazol twice a day |
| Placebo | Placebo comparator | Drug: placebomatching placebo to cilostazol |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic cerebral infarction documented on MRI or CT
- More than 35 years of age
- Patients taking aspirin 100mg a day for 2 weeks or more before randomization
Key exclusion criteria (12 listed)
- Patients taking any antiplatelets other than aspirin within 2 weeks before randomization
- Patients taking any anticoagulants within 2 weeks before randomization
- Patients taking thrombolytic therapy within 2 weeks before randomization
- Patients taking any NSAIDs within 2 weeks before randomization
- Patients who need to take NSAIDs regularly (e.g. rheumatic arthritis).
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 |
|---|---|---|
| CilostazolAlso: pletaalcilostazol 100mg twice a day for 4 weeks | Drug | 1 Cilostazol |
| placeboAlso: matching placebo of cilostazolplacebo 1 tablet twice a day matching for cilostazol | Drug | Placebo |
Primary outcome
Aspirin Resistance (ARU ≥ 550)
Time frame: 4 weeks after treatment
The number of patients with aspirin reaction units (ARUs) values ≥ 550 on the Ultra Rapid Platelet Function Assay-ASA among the recruited patients
6 secondary outcomes
Aspirin Resistance (ARU ≥ 500)
Time frame: 4 weeks after reatment
Bleeding Time (BT)
Time frame: 4 weeks after reatment
Fatal or Major Bleeding Complications;
Time frame: events ocurred during study medication after randomization
Any Bleeding Complications
Time frame: events ocurred during study medication after randomization
Difference of Post-treatment ARU and Baseline ARU
Time frame: baseline ARU measured at the randomization and post-treatment ARU measured at the 4weeks treatment with study medication
Post-treatment ARU
Time frame: after 4 weeks treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sun U Kwon, MD. PhD. principal investigator
Asan Medical Center, Univsersity of Ulsan, Medical College
4 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 in people with Cerebral Infarction, run by Asan Medical Center at 4 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 3 inclusion and 12 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 18 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 18 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Aspirin Resistance (ARU ≥ 550) (time frame: 4 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2010.