DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Seoul National University Bundang Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Effect of Cilostazol on Coronary Artery Stenosis and Plaque Characteristics Assessed by Multidetector-row Cardiac Computed Tomography

Intervention: Cilostazol (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Seoul National University Bundang Hospital

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Coronary artery stenosis

Secondary outcome:

Plaque characteristics

Coronary artery calcium (CAC) score

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

Minimum age: 30 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Seoul National University Bundang Hospital, Seongnam, Bundang-gu 463-707, Korea, Republic of; Recruiting
Soo Lim, Email: limsoo@snu.ac.kr
Additional Information

Starting date: February 2011
Last updated: October 11, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017