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

Coronary Artery Disease Clinical Trial

— SAGE-CAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02607436
• Other study ID #: B-1111/139-007
• Status: Completed
• Phase: Phase 4
• First received: November 12, 2015
• Last updated: May 2, 2016
• Start date: July 2015
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Sarpogrelate
Sarpogrelate
• Aspirin
Aspirin

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary artery disease assessed by cardiac computed tomography angiography		6 months	No
Secondary	Coronary artery calcium score assessed by cardiac computed tomography angiography		6 months	No
Secondary	Coronary artery stenosis assessed by cardiac computed tomography angiography		6 months	No
Secondary	Changes of plaque size assessed by cardiac computed tomography angiography		6 months	No
Secondary	Changes of plaque composition assessed by cardiac computed tomography angiography		6 months	No
Secondary	Changes of Ankle-branchial index		6 months	No
Secondary	Changes of pulse wave velocity		6 months	No
Secondary	Glucose metabolism assessed by glycated hemoglobin		6 months	No
Secondary	Lipid metabolism assessed by triglyceride and high density lipoprotein-cholesterol		6 months	No