Clinical trial NCT02607436: Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on Coronary Artery Disease
Official title: Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on Progression of Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2015-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Coronary artery disease assessed by cardiac computed tomography angiography
timeFrame: 6 months
Secondary outcomes:
measure: Coronary artery calcium score assessed by cardiac computed tomography angiography
timeFrame: 6 months
measure: Coronary artery stenosis assessed by cardiac computed tomography angiography
timeFrame: 6 months
measure: Changes of plaque size assessed by cardiac computed tomography angiography
timeFrame: 6 months
measure: Changes of plaque composition assessed by cardiac computed tomography angiography
timeFrame: 6 months
measure: Changes of Ankle-branchial index
timeFrame: 6 months
measure: Changes of pulse wave velocity
timeFrame: 6 months
measure: Glucose metabolism assessed by glycated hemoglobin
timeFrame: 6 months
measure: Lipid metabolism assessed by triglyceride and high density lipoprotein-cholesterol
timeFrame: 6 months
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: SNUBH
name: Soo Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: