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Type 2 Diabetes MellitusPhase 4NCT02933788

Effect of aSpirin Versus CilOstazol for Inhibition of Antiplatelet aggRegaTion in Type 2 DM Patients

A Phase 4 study testing Cilostazol and Acetylsalicylic acid in people with Type 2 Diabetes Mellitus, run by Kangbuk Samsung Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study evaluates the more suitable treatment for the prevention of vascular complications in diabetes patents who were at high cardiovascular risk group by comparing the platelet aggregation inhibitory effect of aspirin and cilostazol. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Cilostazol and Acetylsalicylic acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
No sites listed yet
Study dates
Oct 2016to Dec 2018
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Who have one more following risk factor:
  • Family history of cardiovascular disease
  • Hypertension
  • Smoking History
  • Dyslipidemia
  • Albuminuria
Show all 9Show fewer
  • Who do not have high risk of bleeding
  • Who stop taking Cilostazol or Aspirin before randomized period 1months or
  • Who have never taken the drugs

Who cannot join

  • Type 1 diabetes mellitus, gestational diabetes
  • Who with history of macrovascular complication including cardiovascular disease, cerebrovascular disease and peripheral vascular disease

Trial locations and contacts

No sites are listed yet.

Ji Hyun Kim, Fellow contact

+2-2001-8503

kjhys0527@hanmail.net

Cheol Young Park, Professor contact

+2-2001-1550

cydoctor@chol.com

About this study

This study evaluates the more suitable treatment for the prevention of vascular complications in diabetes patents who were at high cardiovascular risk group by comparing the platelet aggregation inhibitory effect of aspirin and cilostazol.

Read the detailed description

Diabetes is a dangerous disease with high risk of vascular complications. Thus, to prevent these vascular complication, antithrombotic drug may be administered. Representative antithrombotic agents are aspirin and cilostazol. However, recent studies suggested that aspirin did not have sufficient effect to prevent vascular complications of diabetes. For that reason, it have been reported that antithrombotic effects of aspirin were falling in diabetes patients, so-called 'aspirin resistance.

On the other hand, cilostazol used as the control drug inhibits atherosclerosis in diabetes patients in the studies of Asia including Korea, and it is effective to inhibit the risk of various cardiovascular disease. Therefore, cilostazol is likely to use drugs as substitute for aspirin therapy.

Being tested
Cilostazol, Acetylsalicylic acid
Keywords
cardiovascular disease, atherosclerosis
Medical subject headings
Diabetes Mellitus, Type 2, Cardiovascular Diseases, Atherosclerosis

What participants receive

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

  • CilostazolDrug

    Also called Pletal

    Cilostazol sustained release capsule is new drugs developed by Otsuka Korea. This drugs have platelet aggregation inhibiting action, peripheral vasodilating action and endothelial function improving action.

  • Acetylsalicylic acidDrug

    Also called Aspirin

    Aspirin may prevent coronary thrombosis in patients with cardiovascular event risk factors, such as ischemic heart disease family history, hypertension, diabetes mellitus, dyslipidemia and obesity.

Study groups in NCT02933788
Study groupRoleWhat they receive
Cilostazol groupExperimentalCilostazol Cilostazol 200mg tablet by mouth, once daily for 14 days
Receives: Drug: Cilostazol
Aspirin groupActive comparatorAcetylsalicylic acid Acetylsalicylic acid 100mg tablet by mouth, once daily for 14 days
Receives: Drug: Acetylsalicylic acid

What is being measured

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

  1. platelet reactivity testing

    Blood sampling is collected at baseline and after taking each drugs 14 days, in the fasting state . The rate of Aspirin reaction units(ARU) change compared baseline is measured through Verify Now. The rate of platelet aggregation(seconds) dut to collagen, epinephrine was compared through the platelet function testing-100.

    1. Verify Now(ARU): It is a test developed to monitor the platelet aggregation inhibitory effects of anti-platelet drugs which used to prevent thrombosis and relapse it. By measuring the light transmission change, it outputs result to the aspirin response units(ARU)
    2. Platelet function testing-100: platelet function analyser The cartridge membrane is coated by collagen as initial matrix for platelet adhesion. When platelet adhere to the collagen, it takes place the first physical stimulation. Then, another membrane component, Adenosine diphosphate induces platelet aggregation. The analysis equipment is measuring CT(closing time) in seconds.

    Measured: Change from Baseline 'platelet reactivity testing(Aspirin reaction units and platelet function testing-100) at 14 days

Secondary outcomes (1)

  1. Observation of Clinical laboratory data(total cholesterol, HDL, LDL and triglyceride

    The rate of lipid profile(total cholesterol, HDL, LDL and triglyceride) change which is cardiovascular risk factors and diabetes mellitus complication indicators change are measured at baseline and after taking each drugs for 14 days. Thus, the effect of each drugs preventing complication in patients with diabetes mellitus may be analyzed.

    • total cholesterol(mg/dL)/ HDL(mg/dL)/ LDL(mg/dL)/ triglyceride(mg/dL)/ hsCRP(mg/dL)/ cluster of designation antigen 40(mg/dL)/ Dipeptidyl peptidase-4 enzyme activity(uM/ml)/ total and active glucagon like peptide-1(pmol/l)

    Measured: Change from baseline "total cholesterol, HDL, LDL and triglyceride, hsCRP, cluster of designation antigen 40, ligand, Dipeptidyl peptidase-4 enzyme activity, total and active glucagon like peptide-1' at 14 days.

Timeline

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

  1. First posted14 Oct 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2018 (estimated)

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02933788
Sponsor's protocol ID
ESCORT_DM
Status last verified
Oct 2016
First submitted
18 Sep 2016
Last updated
14 Oct 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Global status report on noncommunicable diseases 2010

  • Emerging Risk Factors Collaboration; Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, Ingelsson E, Lawlor DA, Selvin E, Stampfer M, Stehouwer CD, Lewington S, Pennells L, Thompson A, Sattar N, White IR, Ray KK, Danesh J. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010 Jun 26;375(9733):2215-22. doi: 10.1016/S0140-6736(10)60484-9.

    PubMed 20609967

  • American Diabetes Association. Standards of medical care in diabetes-2015 abridged for primary care providers. Clin Diabetes. 2015 Apr;33(2):97-111. doi: 10.2337/diaclin.33.2.97. No abstract available.

    PubMed 25897193

  • Ogawa H, Nakayama M, Morimoto T, Uemura S, Kanauchi M, Doi N, Jinnouchi H, Sugiyama S, Saito Y; Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial Investigators. Low-dose aspirin for primary prevention of atherosclerotic events in patients with type 2 diabetes: a randomized controlled trial. JAMA. 2008 Nov 12;300(18):2134-41. doi: 10.1001/jama.2008.623. Epub 2008 Nov 9.

    PubMed 18997198

  • Kim JD, Park CY, Ahn KJ, Cho JH, Choi KM, Kang JG, Kim JH, Lee KY, Lee BW, Mok JO, Moon MK, Park JY, Park SW. Non-HDL cholesterol is an independent risk factor for aspirin resistance in obese patients with type 2 diabetes. Atherosclerosis. 2014 May;234(1):146-51. doi: 10.1016/j.atherosclerosis.2014.01.015. Epub 2014 Feb 12.

    PubMed 24657383

  • Cohen HW, Crandall JP, Hailpern SM, Billett HH. Aspirin resistance associated with HbA1c and obesity in diabetic patients. J Diabetes Complications. 2008 May-Jun;22(3):224-8. doi: 10.1016/j.jdiacomp.2007.05.002. Epub 2008 Apr 16.

    PubMed 18413227

  • Araki S, Matsuno H, Haneda M, Koya D, Kanno Y, Kume S, Isshiki K, Araki H, Ugi S, Kawai H, Kashiwagi A, Uzu T, Maegawa H. Cilostazol attenuates spontaneous microaggregation of platelets in type 2 diabetic patients with insufficient platelet response to aspirin. Diabetes Care. 2013 Jul;36(7):e92-3. doi: 10.2337/dc12-2702. No abstract available.

    PubMed 23801816

  • Henn V, Slupsky JR, Grafe M, Anagnostopoulos I, Forster R, Muller-Berghaus G, Kroczek RA. CD40 ligand on activated platelets triggers an inflammatory reaction of endothelial cells. Nature. 1998 Feb 5;391(6667):591-4. doi: 10.1038/35393.

    PubMed 9468137

  • Davi G, Catalano I, Averna M, Notarbartolo A, Strano A, Ciabattoni G, Patrono C. Thromboxane biosynthesis and platelet function in type II diabetes mellitus. N Engl J Med. 1990 Jun 21;322(25):1769-74. doi: 10.1056/NEJM199006213222503.

    PubMed 2345567

  • Hong S, Lee WJ, Park CY. Comparative Study of Ex Vivo Antiplatelet Activity of Aspirin and Cilostazol in Patients with Diabetes and High Risk of Cardiovascular Disease. Endocrinol Metab (Seoul). 2022 Apr;37(2):233-242. doi: 10.3803/EnM.2021.1353. Epub 2022 Apr 6.

    PubMed 35381686

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cilostazol and Acetylsalicylic acid in people with Type 2 Diabetes Mellitus, run by Kangbuk Samsung Hospital.

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 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: status not confirmed, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Ji Hyun Kim, Fellow (+2-2001-8503, kjhys0527@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

platelet reactivity testing (time frame: Change from Baseline 'platelet reactivity testing(Aspirin reaction units and platelet function testing-100) at 14 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 NCT02933788, which also lists 10 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 14 Oct 2016.

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