Effect of Cilostazol on Coronary Artery Stenosis and Plaque Characteristics in Patients With T2DM (ESCAPE)
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|ClinicalTrials.gov Identifier: NCT02266030|
Recruitment Status : Completed
First Posted : October 16, 2014
Last Update Posted : October 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Cilostazol Drug: Aspirin||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Cilostazol on Coronary Artery Stenosis and Plaque Characteristics in Patients With Type 2 Diabetes Mellitus|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
Cilostazol 100-200 mg qd
Pletaal as an active drug
Other Name: Pletaal
Active Comparator: Aspirin
Asprin 100mg qd for active comparator
Aspirin as an active comparator
- Coronary artery stenosis [ Time Frame: one year ]Severity of coronary artery stenosis (%)
- Plaque characteristics [ Time Frame: one year ]Noncalified plaque
- Plaque characteristics [ Time Frame: one year ]Mixed plaque
- Plaque characteristics [ Time Frame: one year ]Calcified plaque
- Multivessel involvement [ Time Frame: one year ]Multivessel involvement in coronary arteries
- Main vessel involvement [ Time Frame: one year ]Left main and/or proximal LAD stenosis
- Coronary artery calcium (CAC) score [ Time Frame: one year ]Agatston score for CAC
- Glucose homeostasis [ Time Frame: one year ]Changes in HbA1c
- Glucose homeostasis [ Time Frame: one year ]Changes in fasting glucose concentration
- Lipid metabolism [ Time Frame: one year ]Changes in TG concentration
- Lipid metabolism [ Time Frame: one year ]Changes in HDL-concentration concentration
- Bleeding risk [ Time Frame: one year ]Any type of bleeding
- Headache [ Time Frame: one year ]Any type of headache
- Heart rate [ Time Frame: one year ]Frequence of heart beat per min
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266030
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam, Bundang-gu, Korea, Republic of, 463-707|
|Principal Investigator:||Soo Lim, MD, PhD||SNUBH|