Clinical trial NCT02266030: Effect of Cilostazol on Coronary Artery Stenosis and Plaque Characteristics in Patients With T2DM
Official title: Effect of Cilostazol on Coronary Artery Stenosis and Plaque Characteristics in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2014-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Coronary artery stenosis
timeFrame: one year
Secondary outcomes:
measure: Plaque characteristics
timeFrame: one year
measure: Plaque characteristics
timeFrame: one year
measure: Plaque characteristics
timeFrame: one year
measure: Multivessel involvement
timeFrame: one year
measure: Main vessel involvement
timeFrame: one year
measure: Coronary artery calcium (CAC) score
timeFrame: one year
measure: Glucose homeostasis
timeFrame: one year
measure: Glucose homeostasis
timeFrame: one year
measure: Lipid metabolism
timeFrame: one year
measure: Lipid metabolism
timeFrame: one year
Other outcomes:
measure: Bleeding risk
timeFrame: one year
measure: Headache
timeFrame: one year
measure: Heart rate
timeFrame: one year
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Bundang-gu
Study officials:
affiliation: SNUBH
name: Soo Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: