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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cilostazol group

Cilostazol Cilostazol 200mg tablet by mouth, once daily for 14 days

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

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 group

Acetylsalicylic acid Acetylsalicylic acid 100mg tablet by mouth, once daily for 14 days

Group Type ACTIVE_COMPARATOR

Acetylsalicylic acid

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Pletal Aspirin

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No