Effect of aSpirin Versus CilOstazol for Inhibition of Antiplatelet aggRegaTion in Type 2 DM Patients
1 other identifier
interventional
116
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 type-2-diabetes-mellitus
Started Oct 2016
Typical duration for phase_4 type-2-diabetes-mellitus
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedFirst Posted
Study publicly available on registry
October 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 14, 2016
October 1, 2016
2 months
September 18, 2016
October 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Change from Baseline 'platelet reactivity testing(Aspirin reaction units and platelet function testing-100) at 14 days
Secondary Outcomes (1)
Observation of Clinical laboratory data(total cholesterol, HDL, LDL and triglyceride
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.
Study Arms (2)
Cilostazol group
EXPERIMENTALCilostazol Cilostazol 200mg tablet by mouth, once daily for 14 days
Aspirin group
ACTIVE COMPARATORAcetylsalicylic acid Acetylsalicylic acid 100mg tablet by mouth, once daily for 14 days
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Who have one more following risk factor:
- Family history of cardiovascular disease
- Hypertension
- Smoking History
- Dyslipidemia
- Albuminuria
- 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
You may not qualify if:
- Type 1 diabetes mellitus, gestational diabetes
- Who with history of macrovascular complication including cardiovascular disease, cerebrovascular disease and peripheral vascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kangbuk Samsung Hospitallead
- Asan Medical Centercollaborator
Related Publications (10)
Global status report on noncommunicable diseases 2010
BACKGROUNDEmerging 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.
PMID: 20609967BACKGROUNDAmerican 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.
PMID: 25897193BACKGROUNDOgawa 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.
PMID: 18997198BACKGROUNDKim 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.
PMID: 24657383BACKGROUNDCohen 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.
PMID: 18413227BACKGROUNDAraki 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.
PMID: 23801816BACKGROUNDHenn 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.
PMID: 9468137BACKGROUNDDavi 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.
PMID: 2345567BACKGROUNDHong 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.
PMID: 35381686DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheol Young Park, Professor
Kanbuk Samsung Diabetes Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fellowship
Study Record Dates
First Submitted
September 18, 2016
First Posted
October 14, 2016
Study Start
October 1, 2016
Primary Completion
December 1, 2016
Study Completion
December 1, 2018
Last Updated
October 14, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share