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

Kangbuk Samsung Hospital

Status and phase: Unknown; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Cilostazol; Drug: Acetylsalicylic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02933788

ESCORT_DM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Cilostazol group

Experimental group

Description:

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

Treatment:

Drug: Cilostazol

Aspirin group

Active Comparator group

Description:

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

Treatment:

Drug: Acetylsalicylic acid