Effect of Cilostazol on Coronary Artery Stenosis and Plaque Characteristics in Patients With T2DM

Phase 3

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Cilostazol; Drug: Aspirin

• Registration Number: NCT02266030
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

This is a prospective interventional study to assess the effect of cilostazol compared with aspirin in Korean T2DM patients with atherosclerosis.

Detailed Description

Type 2 diabetes has been increased exponentially, arousing serious economic, social and health repercussions. Also, macrovascular complications of diabetes such as myocardial infarct or stroke have been increased. Individuals with diabetes have a greater risk of cardiovascular disease (CVD), approximately two to four times than that of those without diabetes. Currently, the U.S. Food and Drug Administration requires demonstration that new anti-hyperglycemic agents do not increase CV risk. The comprehensive and multifactorial management in type 2 diabetes, which includes control of hypertension, dyslipidemia and obesity, is known to significantly reduce the risk of CVD as shown in Steno-2 study. However, most anti-diabetic agents currently used in clinical practice do not seem to provide enough CV protection.

This is a prospective interventional study to assess the effect of cilostazol compared with aspirin in Korean T2DM patients with atherosclerosis. T2DM patients who have coronary artery stenosis by MDCT at least 3 months prior to this investigation will be enrolled.

Considering drop out due to adverse events or follow up loss, sufficient patients will be enrolled. Their medical record will be reviewed and relevant clinical and laboratory findings will be collected.

Cardiac computed tomography (CT) was introduced in the early 1990s. However, electron-beam CT (EBCT) only provided information on simple coronary artery calcium score (CAC). Recently, MDCT has been introduced, which can evaluate coronary arteries comprehensively. MDCT images can provide measurements of CAC, the degree of stenosis, and the characteristics of plaque including its potential vulnerability. These findings of MDCT have been reported to be in good agreement with intravascular ultrasound.

All scans are analyzed independently by two experienced investigators using a 3D workstation, who are blinded to the clinical information (Brilliance; Philips Medical Systems). After independent evaluations are made, a consensus interpretation is arrived at regarding the final MDCT diagnosis. Each lesion is identified using a multiplanar reconstruction technique and maximum intensity projection of the short axis, in two-chamber and four-chamber views. Image quality is evaluated on a per-segment basis and classified. Plaque characteristics on a per-segment basis are analyzed according to the modified American Heart Association classification.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2014-10-11
• Study First Submitted QC: 2014-10-11
• Study First Posted: 2014-10-16
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-05
• Last Update Posted: 2017-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Type 2 diabetes with HbA1c ≥ 6.0% at screening visit
• Male or female between 30 and 80 years of age
• Coronary artery stenosis: 25-75% without no evidence of acute coronary syndrome
• No history of previous myocardial infarction
• Estimated GFR ≥ 60 ml/min/1.73m²

Exclusion Criteria

• SBP/DBP> 160/110
• Congestive heart failure
• Allegy to radiocontrast dye
• Allegy to aspirin or cilostazol
• Acute bleeding
• History of ulcer bleeding
• GOT/GPT > 100/100
• Other antiplatlet medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cilostazol	Cilostazol	Cilostazol 100-200 mg qd
Aspirin	Aspirin	Asprin 100mg qd for active comparator

Primary Outcome Measures

Name	Time	Method
Coronary artery stenosis	one year	Severity of coronary artery stenosis (%)

Secondary Outcome Measures

Name	Time	Method
Plaque characteristics	one year	Calcified plaque
Main vessel involvement	one year	Left main and/or proximal LAD stenosis
Coronary artery calcium (CAC) score	one year	Agatston score for CAC
Glucose homeostasis	one year	Changes in fasting glucose concentration
Lipid metabolism	one year	Changes in HDL-concentration concentration
Multivessel involvement	one year	Multivessel involvement in coronary arteries

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Bundang-gu, Korea, Republic of