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

Coronary Artery Disease Clinical Trial

— ESCAPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02266030
• Other study ID #: B-1010/114-005
• Status: Completed
• Phase: Phase 3
• First received: October 11, 2014
• Last updated: October 5, 2017
• Start date: February 2011
• Est. completion date: November 2016

Study information

• Verified date: October 2017
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Stenosis
• Myocardial Ischemia

Intervention

Drug:
• Cilostazol
Pletaal as an active drug
• Aspirin
Aspirin as an active comparator

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Bundang-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bleeding risk	Any type of bleeding	one year
Other	Headache	Any type of headache	one year
Other	Heart rate	Frequence of heart beat per min	one year
Primary	Coronary artery stenosis	Severity of coronary artery stenosis (%)	one year
Secondary	Plaque characteristics	Noncalified plaque	one year
Secondary	Plaque characteristics	Mixed plaque	one year
Secondary	Plaque characteristics	Calcified plaque	one year
Secondary	Multivessel involvement	Multivessel involvement in coronary arteries	one year
Secondary	Main vessel involvement	Left main and/or proximal LAD stenosis	one year
Secondary	Coronary artery calcium (CAC) score	Agatston score for CAC	one year
Secondary	Glucose homeostasis	Changes in HbA1c	one year
Secondary	Glucose homeostasis	Changes in fasting glucose concentration	one year
Secondary	Lipid metabolism	Changes in TG concentration	one year
Secondary	Lipid metabolism	Changes in HDL-concentration concentration	one year