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

May 2, 2016 updated by: Soo Lim, Seoul National University Bundang Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Soo Lim, MD, PhD, SNUBH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • B-1111/139-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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