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

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