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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02933788
• Other study ID #: ESCORT_DM
• Status: Not yet recruiting
• Phase: Phase 4
• First received: September 18, 2016
• Last updated: October 12, 2016
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2016
• Source: Kangbuk Samsung Hospital
• Contact: Ji Hyun Kim, Fellow
• Phone: +2-2001-8503
• Email: kjhys0527[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 116
• Est. completion date: December 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Type 1 diabetes mellitus, gestational diabetes

• Who with history of macrovascular complication including cardiovascular disease, cerebrovascular disease and peripheral vascular disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Cilostazol
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 acid
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital	Asan Medical Center

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

Davì 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. — View Citation

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. Erratum in: Lancet. 2010 Sep 18;376(9745):958. Hillage, H L [corrected to Hillege, H L]. — View Citation

Global status report on noncommunicable diseases 2010

Henn V, Slupsky JR, Gräfe M, Anagnostopoulos I, Förster R, Müller-Berghaus G, Kroczek RA. CD40 ligand on activated platelets triggers an inflammatory reaction of endothelial cells. Nature. 1998 Feb 5;391(6667):591-4. — View Citation

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. — View Citation

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. Erratum in: JAMA. 2009 May 13;301(18):1882. JAMA. 2012 Nov 14;308(18):1861. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.; 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); 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	Yes
Secondary	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)	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.	Yes

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