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

October 12, 2016 updated by: Ji Hyun Kim, Kangbuk Samsung Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

116

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Cheol Young Park, Professor
  • Phone Number: +2-2001-1550
  • Email: cydoctor@chol.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cilostazol group
Cilostazol Cilostazol 200mg tablet by mouth, once daily for 14 days
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.
Other Names:
  • Pletal
ACTIVE_COMPARATOR: Aspirin group
Acetylsalicylic acid Acetylsalicylic acid 100mg tablet by mouth, once daily for 14 days
Drug: 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.
Other Names:
  • Aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
platelet reactivity testing
Time Frame: Change from Baseline 'platelet reactivity testing(Aspirin reaction units and platelet function testing-100) at 14 days

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observation of Clinical laboratory data(total cholesterol, HDL, LDL and triglyceride
Time Frame: 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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kangbuk Samsung Hospital

Collaborators

Asan Medical Center

Investigators

  • Principal Investigator: Cheol Young Park, Professor, Kanbuk Samsung Diabetes Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

September 18, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (ESTIMATE)

October 14, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESCORT_DM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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