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Completed

NCT Number: NCT02607436

Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on 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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sarpogrelate

Drug

Sarpogrelate

Other names: Anplag

Aspirin

Drug

Aspirin

Other names: Aspirin protect or Astrix

Primary outcomes

  1. Coronary artery disease assessed by cardiac computed tomography angiography

    Time frame: 6 months

Secondary outcomes

  1. Coronary artery calcium score assessed by cardiac computed tomography angiography

    Time frame: 6 months

  2. Coronary artery stenosis assessed by cardiac computed tomography angiography

    Time frame: 6 months

  3. Changes of plaque size assessed by cardiac computed tomography angiography

    Time frame: 6 months

  4. Changes of plaque composition assessed by cardiac computed tomography angiography

    Time frame: 6 months

  5. Changes of Ankle-branchial index

    Time frame: 6 months

  6. Changes of pulse wave velocity

    Time frame: 6 months

  7. Glucose metabolism assessed by glycated hemoglobin

    Time frame: 6 months

  8. Lipid metabolism assessed by triglyceride and high density lipoprotein-cholesterol

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Acronym: SAGE-CAD

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 18, 2015
Registry last updated
May 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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