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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sarpogrelate
Aspirin
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sarpogrelate + Aspirin

Aspirin alone

Arm Description

Sarpogrelate as an active drug

Aspirin as an active comparator

Outcomes

Primary Outcome Measures

Coronary artery disease assessed by cardiac computed tomography angiography

Secondary Outcome Measures

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

Full Information

First Posted
November 12, 2015
Last Updated
May 2, 2016
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02607436
Brief Title
Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on Coronary Artery Disease
Acronym
SAGE-CAD
Official Title
Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on Progression of Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sarpogrelate + Aspirin
Arm Type
Experimental
Arm Description
Sarpogrelate as an active drug
Arm Title
Aspirin alone
Arm Type
Active Comparator
Arm Description
Aspirin as an active comparator
Intervention Type
Drug
Intervention Name(s)
Sarpogrelate
Other Intervention Name(s)
Anplag
Intervention Description
Sarpogrelate
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Aspirin protect or Astrix
Intervention Description
Aspirin
Primary Outcome Measure Information:
Title
Coronary artery disease assessed by cardiac computed tomography angiography
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Coronary artery calcium score assessed by cardiac computed tomography angiography
Time Frame
6 months
Title
Coronary artery stenosis assessed by cardiac computed tomography angiography
Time Frame
6 months
Title
Changes of plaque size assessed by cardiac computed tomography angiography
Time Frame
6 months
Title
Changes of plaque composition assessed by cardiac computed tomography angiography
Time Frame
6 months
Title
Changes of Ankle-branchial index
Time Frame
6 months
Title
Changes of pulse wave velocity
Time Frame
6 months
Title
Glucose metabolism assessed by glycated hemoglobin
Time Frame
6 months
Title
Lipid metabolism assessed by triglyceride and high density lipoprotein-cholesterol
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo Lim, MD, PhD
Organizational Affiliation
SNUBH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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