Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on Coronary Artery Disease (SAGE-CAD)

Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on Progression of Coronary Artery Disease

This is a prospective interventional study to assess the effect of sarpogrelate compared with aspirin in Korean type 2 diabetic patients with atherosclerosis.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Aspirin; Drug: Sarpogrelate

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Seongnam, Gyeonggi, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sarpogrelate + Aspirin; Sarpogrelate as an active drug	Drug: Aspirin; Aspirin; Other Names: Aspirin protect or Astrix; Drug: Sarpogrelate; Sarpogrelate; Other Names: Anplag
Active Comparator: Aspirin alone; Aspirin as an active comparator	Drug: Aspirin; Aspirin; Other Names: Aspirin protect or Astrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Coronary artery disease assessed by cardiac computed tomography angiography	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Coronary artery calcium score assessed by cardiac computed tomography angiography	6 months
Coronary artery stenosis assessed by cardiac computed tomography angiography	6 months
Changes of plaque size assessed by cardiac computed tomography angiography	6 months
Changes of plaque composition assessed by cardiac computed tomography angiography	6 months
Changes of Ankle-branchial index	6 months
Changes of pulse wave velocity	6 months
Glucose metabolism assessed by glycated hemoglobin	6 months
Lipid metabolism assessed by triglyceride and high density lipoprotein-cholesterol	6 months

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Soo Lim, MD, PhD, SNUBH

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: November 12, 2015
• First Submitted That Met QC Criteria: November 16, 2015
• First Posted (Estimate): November 18, 2015

Study Record Updates

• Last Update Posted (Estimate): May 3, 2016
• Last Update Submitted That Met QC Criteria: May 2, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Serotonin Agents; Serotonin Antagonists; Aspirin; Sarpogrelate
• Other Study ID Numbers: B-1111/139-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO