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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Aspirin; Drug: Sarpogrelate

Study type: Interventional

Funder types: Other

Identifiers

NCT02607436

B-1111/139-007

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Sarpogrelate + Aspirin

Experimental group

Description:

Sarpogrelate as an active drug

Treatment:

Drug: Sarpogrelate

Drug: Aspirin

Aspirin alone

Active Comparator group

Description:

Aspirin as an active comparator

Treatment:

Drug: Aspirin