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

Effect of Cilostazol on Coronary Artery Stenosis and Plaque Characteristics in Patients With Type 2 Diabetes Mellitus

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02266030
Acronym
ESCAPE
Enrollment
100
Registered
2014-10-16
Start date
2011-02-28
Completion date
2016-11-30
Last updated
2017-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

DRUGCilostazol

Pletaal as an active drug

DRUGAspirin

Aspirin as an active comparator

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Coronary artery stenosisone yearSeverity of coronary artery stenosis (%)

Secondary

MeasureTime frameDescription
Main vessel involvementone yearLeft main and/or proximal LAD stenosis
Coronary artery calcium (CAC) scoreone yearAgatston score for CAC
Glucose homeostasisone yearChanges in HbA1c
Lipid metabolismone yearChanges in TG concentration
Plaque characteristicsone yearNoncalified plaque
Multivessel involvementone yearMultivessel involvement in coronary arteries

Other

MeasureTime frameDescription
Heart rateone yearFrequence of heart beat per min
Bleeding riskone yearAny type of bleeding
Headacheone yearAny type of headache

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026