Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Carotid Atherosclerosis; Type 2 Diabetes Mellitus

Treatments: Drug: Cilostazol; Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT03248401

Cilostazol_Carotid a. plaque

Details and patient eligibility

About

To investigate the effect of cilostazol compared with aspirin on carotid atherosclerosis in patients with type 2 diabetes mellitus

Enrollment: 50 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 30 and 80 years
• Patients with type 2 diabetes on treatment (HbA1c 6.0-11.0%)
• Carotid plaque on 3D ultrasound

Exclusion criteria

• Acute bleeding or bleeding tendency
• Diagnosed with heart failure
• Suggestive of ischemia on ECG
• Uncontrolled hypertension
• Recently diagnosed with peptic ulcer disease
• Taking other antiplatelet agents
• Hypersensitivity to salicylic acid
• Aspirin induced asthma
• Severe kidney, liver, heart disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Cilostazol group

Experimental group

Description:

Cilostazol 200 mg or maximal tolerate dose

Treatment:

Drug: Cilostazol

Aspirin group

Active Comparator group

Description:

Aspirin 100 mg

Treatment:

Drug: Aspirin