Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on Coronary Artery Disease
Overview
This is a prospective interventional study to assess the effect of sarpogrelate compared with aspirin in Korean type 2 diabetic patients with atherosclerosis.
Full Title of Study: “Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on Progression of Coronary Artery Disease”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: February 2016
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 cardiovascular 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 cardiovascular protection.
Interventions
- Drug: Sarpogrelate
- Sarpogrelate
- Drug: Aspirin
- Aspirin
Arms, Groups and Cohorts
- Experimental: Sarpogrelate + Aspirin
- Sarpogrelate as an active drug
- Active Comparator: Aspirin alone
- Aspirin as an active comparator
Clinical Trial Outcome Measures
Primary Measures
- Coronary artery disease assessed by cardiac computed tomography angiography
- Time Frame: 6 months
Secondary Measures
- Coronary artery calcium score assessed by cardiac computed tomography angiography
- Time Frame: 6 months
- Coronary artery stenosis assessed by cardiac computed tomography angiography
- Time Frame: 6 months
- Changes of plaque size assessed by cardiac computed tomography angiography
- Time Frame: 6 months
- Changes of plaque composition assessed by cardiac computed tomography angiography
- Time Frame: 6 months
- Changes of Ankle-branchial index
- Time Frame: 6 months
- Changes of pulse wave velocity
- Time Frame: 6 months
- Glucose metabolism assessed by glycated hemoglobin
- Time Frame: 6 months
- Lipid metabolism assessed by triglyceride and high density lipoprotein-cholesterol
- Time Frame: 6 months
Participating in This Clinical Trial
Inclusion Criteria
- Type 2 diabetes with HbA1c ≥ 6.5% at screening visit – Male or female between 30 and 80 years of age – Coronary artery stenosis: 10-75% without no evidence of acute coronary syndrome – No history of previous myocardial infarction Exclusion Criteria:
- Systolic blood pressure / diastolic blood pressure > 160/110 mmHg – Congestive heart failure – Allergy to radiocontrast dye – Allergy to aspirin or sarpogrelate – Acute bleeding – History of ulcer bleeding – GOT/GPT > 100/100 – Other antiplatelet medication
Gender Eligibility: All
Minimum Age: 30 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Seoul National University Bundang Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Soo Lim, Associate Professor – Seoul National University Bundang Hospital
- Overall Official(s)
- Soo Lim, MD, PhD, Principal Investigator, SNUBH
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.