Type 2 Diabetes MellitusPhase 4CAPPANCT00886574
Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events
A Phase 4 study testing Cilostazol and Aspirin in people with Type 2 Diabetes Mellitus, run by Hanyang University at 6 sites in South Korea.
Trial summary
This multi-center, randomized controlled study aims to evaluate the efficacy of Cilostazol versus Aspirin for primary prevention of atherosclerotic events with Korean type 2 Diabetes Mellitus (DM) patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Cilostazol and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Apr 2009to Feb 2014
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus with high risk of macrovascular complications; high risk is one or more as follows:
- Hypertension (≧ 140/90 or anti-hypertensive therapy)
- Hypercholesterolemia (LDL-C > 130 mg/dL or anti-hyperlipidemic therapy)
- TG > 200 mg/dL
- Non proliferative retinopathy or macular edema
- Microalbuminuria or macroalbuminuria
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- Smoker
- Patients on no anti PLT drug history
- Patients who are agree with this research
Who cannot join
- Type 1 diabetes mellitus
- Macrovascular complication history
- Uncontrolled hypertension, unstable angina history
- Congestive heart failure
- Bleeding tendency
- Chronic liver disease (ALT > 100 or AST > 100) or Chronic renal disease creatinine > 3.0 mg/dl)
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- Anemia (hemoglobin < 10 mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3)
- Pregnant or lactation women
- Plan to be revascularized in 4 weeks
- Plan to go to surgery or invasive intervention in 4 weeks
- Plan to need to admission for acute cardiovascular disease in 4 weeks
- Contraindication of this medication
- Other anti-PLT drug therapy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Inha University Hospital
Incheon
Hallym University Hospital
Pyungcheon
Hallym University Hospital
Seoul
Korea University Guro Hospital
Seoul
Kyung hee University Medical Center
Seoul
Ajou University Hospital
Suwon
About this study
Official title: Multi-Center, Randomized, Open Label Study of the Efficacy of Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events With Korean Type 2 DM Patients
This multi-center, randomized controlled study aims to evaluate the efficacy of Cilostazol versus Aspirin for primary prevention of atherosclerotic events with Korean type 2 Diabetes Mellitus (DM) patients.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Cilostazol, Aspirin
- Keywords
- Cilostazol versus Aspirin, Anti-PLT drug, Primary Prevention of Atherosclerotic Events, Type 2 DM, Intima media thickness (IMT)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CilostazolDrug
Also called Pletaal
Cilostazol 200 mg (50 mg 2T twice per day)
AspirinDrug
100 mg once a day
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Active comparator | Aspirin 100 mg once a day Receives: Drug: Aspirin |
| Cilostazol | Active comparator | Cilostazol 200 mg (50 mg 2T twice per day) Receives: Drug: Cilostazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal and mean intima media thickness (IMT) of both common carotid artery of the cilostazol group in comparison with the aspirin group
Measured: every 6 months following randomization, for 48 months
Secondary outcomes (4)
Events of the ischemic heart disease
Measured: every 12 months following randomization, for 48 months
Events of cerebrovascular disease
Measured: every 12 months following randomization, for 48 months
Events of peripheral vascular disease
Measured: every 12 months following randomization, for 48 months
Events of hemorrhagic vascular complication
Measured: every 12 months following randomization, for 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Collaborators
- Ajou University School of Medicine, Kyunghee University Medical Center, Korea University Guro Hospital, Inha University Hospital, Inje University, Hallym University Medical Center
- Investigators
- Yongsoo Park, M.D. Ph.D, Principal investigator, Department of Internal Medicine, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886574
- Sponsor's protocol ID
- HY-2009-11
- Acronym
- CAPPA
- Status last verified
- May 2010
- First submitted
- 22 Apr 2009
- Last updated
- 4 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Randomized, Open Label Study of the Efficacy of Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events With Korean Type 2 DM Patients
- ClinicalTrials.gov ID
- NCT00886574
- Acronym / sponsor ID
- CAPPA / HY-2009-11
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Cilostazol versus Aspirin, Anti-PLT drug, Primary Prevention of Atherosclerotic Events, Type 2 DM, Intima media thickness (IMT)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Collaborators
- Ajou University School of Medicine, Kyunghee University Medical Center, Korea University Guro Hospital, Inha University Hospital, Inje University, Hallym University Medical Center
- Study start
- Apr 2009
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 23 Apr 2009 (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.
This multi-center, randomized controlled study aims to evaluate the efficacy of Cilostazol versus Aspirin for primary prevention of atherosclerotic events with Korean type 2 Diabetes Mellitus (DM) patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Active comparator | Drug: AspirinAspirin 100 mg once a day |
| Cilostazol | Active comparator | Drug: CilostazolCilostazol 200 mg (50 mg 2T twice per day) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Type 2 diabetes mellitus with high risk of macrovascular complications; high risk is one or more as follows:
- Patients on no anti PLT drug history
- Patients who are agree with this research
Key exclusion criteria (13 listed)
- Type 1 diabetes mellitus
- Macrovascular complication history
- Uncontrolled hypertension, unstable angina history
- Congestive heart failure
- Bleeding tendency
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 200 mg (50 mg 2T twice per day) | Drug | Cilostazol |
| Aspirin100 mg once a day | Drug | Aspirin |
Primary outcome
Maximal and mean intima media thickness (IMT) of both common carotid artery of the cilostazol group in comparison with the aspirin group
Time frame: every 6 months following randomization, for 48 months
4 secondary outcomes
Events of the ischemic heart disease
Time frame: every 12 months following randomization, for 48 months
Events of cerebrovascular disease
Time frame: every 12 months following randomization, for 48 months
Events of peripheral vascular disease
Time frame: every 12 months following randomization, for 48 months
Events of hemorrhagic vascular complication
Time frame: every 12 months following randomization, for 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2010.
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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.
Yongsoo Park, M.D. Ph.D principal investigator
Department of Internal Medicine, Hanyang University
6 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 Type 2 Diabetes Mellitus, run by Hanyang University at 6 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 9 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 4 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Results are not available in the source record.
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?
Maximal and mean intima media thickness (IMT) of both common carotid artery of the cilostazol group in comparison with the aspirin group (time frame: every 6 months following randomization, for 48 months). 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 4 Jun 2010.