Type 2 Diabetes MellitusPhase 4NCT03248401
Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
A Phase 4 study testing Cilostazol and Aspirin in people with Type 2 Diabetes Mellitus and Carotid Atherosclerosis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
To investigate the effect of cilostazol compared with aspirin on carotid atherosclerosis in patients with type 2 diabetes mellitus Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Carotid Atherosclerosis
- What is being tested?
- Cilostazol and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Sep 2016to 31 Dec 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 30 and 80 years
- Patients with type 2 diabetes on treatment (HbA1c 6.0-11.0%)
- Carotid plaque on 3D ultrasound
Who cannot join
- Acute bleeding or bleeding tendency
- Diagnosed with heart failure
- Suggestive of ischemia on ECG
- Uncontrolled hypertension
- Recently diagnosed with peptic ulcer disease
- Taking other antiplatelet agents
Show all 9Show fewer
- Hypersensitivity to salicylic acid
- Aspirin induced asthma
- Severe kidney, liver, heart disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Effect of Cilostazol, a Phosphodiesterase 3 Inhibitor, on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
To investigate the effect of cilostazol compared with aspirin on carotid atherosclerosis in patients with type 2 diabetes mellitus
- Conditions
- Type 2 Diabetes Mellitus, Carotid Atherosclerosis
- Being tested
- Cilostazol, Aspirin
- Medical subject headings
- Diabetes Mellitus, Type 2, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CilostazolDrug
Cilostazol 200 mg/day
AspirinDrug
Aspirin 100 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol group | Experimental | Cilostazol 200 mg or maximal tolerate dose Receives: Drug: Cilostazol |
| Aspirin group | Active comparator | Aspirin 100 mg Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of carotid artery atherosclerosis
Plaque composition
Measured: 6 months
Secondary outcomes (3)
Change of carotid artery atherosclerosis 1
Changes in carotid intima-media thickness after treatment
Measured: 6 months
Change of carotid artery atherosclerosis 2
Changes in carotid artery stenosis after treatment
Measured: 6 months
Change of carotid artery atherosclerosis 3
Plaque volume in carotid artery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start26 Sep 2016
- Primary completion21 Oct 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248401
- Sponsor's protocol ID
- Cilostazol_Carotid a. plaque
- Status last verified
- Apr 2020
- First submitted
- 9 Aug 2017
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Katakami N, Kim YS, Kawamori R, Yamasaki Y. The phosphodiesterase inhibitor cilostazol induces regression of carotid atherosclerosis in subjects with type 2 diabetes mellitus: principal results of the Diabetic Atherosclerosis Prevention by Cilostazol (DAPC) study: a randomized trial. Circulation. 2010 Jun 15;121(23):2584-91. doi: 10.1161/CIRCULATIONAHA.109.892414. Epub 2010 Jun 1.
PubMed 20516379Huh JH, Seok H, Lee BW, Kang ES, Lee HC, Cha BS. Effect of cilostazol on carotid intima-media thickness in type 2 diabetic patients without cardiovascular event. Endocrine. 2014 Sep;47(1):138-45. doi: 10.1007/s12020-013-0120-y. Epub 2014 Jan 1.
PubMed 24381128Lee DH, Chun EJ, Moon JH, Yun HM, Lim S. Effect of cilostazol on carotid plaque volume measured by three-dimensional ultrasonography in patients with type 2 diabetes: The FANCY study. Diabetes Obes Metab. 2020 Dec;22(12):2257-2266. doi: 10.1111/dom.14147. Epub 2020 Sep 17.
PubMed 32700396
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cilostazol, a Phosphodiesterase 3 Inhibitor, on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03248401
- Acronym / sponsor ID
- Cilostazol_Carotid a. plaque
- Conditions
- Type 2 Diabetes Mellitus, Carotid Atherosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 26 Sep 2016 (actual)
- Primary completion
- 21 Oct 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 14 Aug 2017 (actual)
- 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.
To investigate the effect of cilostazol compared with aspirin on carotid atherosclerosis in patients with type 2 diabetes mellitus
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 |
|---|---|---|
| Cilostazol group | Experimental | Drug: CilostazolCilostazol 200 mg or maximal tolerate dose |
| Aspirin group | Active comparator | Drug: AspirinAspirin 100 mg |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 30 and 80 years
- Patients with type 2 diabetes on treatment (HbA1c 6.0-11.0%)
- Carotid plaque on 3D ultrasound
Key exclusion criteria (9 listed)
- Acute bleeding or bleeding tendency
- Diagnosed with heart failure
- Suggestive of ischemia on ECG
- Uncontrolled hypertension
- Recently diagnosed with peptic ulcer disease
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 |
|---|---|---|
| CilostazolCilostazol 200 mg/day | Drug | Cilostazol group |
| AspirinAspirin 100 mg/day | Drug | Aspirin group |
Primary outcome
Change of carotid artery atherosclerosis
Time frame: 6 months
Plaque composition
3 secondary outcomes
Change of carotid artery atherosclerosis 1
Time frame: 6 months
Change of carotid artery atherosclerosis 2
Time frame: 6 months
Change of carotid artery atherosclerosis 3
Time frame: 6 months
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 8 Apr 2020.
- Background: PubMed 20516379Katakami N, Kim YS, Kawamori R, Yamasaki Y. The phosphodiesterase inhibitor cilostazol induces regression of carotid atherosclerosis in subjects with type 2 diabetes mellitus: principal results of the Diabetic Atherosclerosis Prevention by Cilostazol (DAPC) study: a randomized trial. Circulation. 2010 Jun 15;121(23):2584-91. doi: 10.1161/CIRCULATIONAHA.109.892414. Epub 2010 Jun 1.
- Background: PubMed 24381128Huh JH, Seok H, Lee BW, Kang ES, Lee HC, Cha BS. Effect of cilostazol on carotid intima-media thickness in type 2 diabetic patients without cardiovascular event. Endocrine. 2014 Sep;47(1):138-45. doi: 10.1007/s12020-013-0120-y. Epub 2014 Jan 1.
- Derived from this study: PubMed 32700396Lee DH, Chun EJ, Moon JH, Yun HM, Lim S. Effect of cilostazol on carotid plaque volume measured by three-dimensional ultrasonography in patients with type 2 diabetes: The FANCY study. Diabetes Obes Metab. 2020 Dec;22(12):2257-2266. doi: 10.1111/dom.14147. Epub 2020 Sep 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 and Carotid Atherosclerosis, run by Seoul National University Bundang Hospital at 1 site 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 9 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 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change of carotid artery atherosclerosis (time frame: 6 months). 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 NCT03248401, which also lists 3 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 8 Apr 2020.