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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02607436
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Sarpogrelate Drug: Aspirin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on Progression of Coronary Artery Disease
Study Start Date : July 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sarpogrelate + Aspirin
Sarpogrelate as an active drug
Drug: Sarpogrelate
Sarpogrelate
Other Name: Anplag

Drug: Aspirin
Aspirin
Other Name: Aspirin protect or Astrix

Active Comparator: Aspirin alone
Aspirin as an active comparator
Drug: Aspirin
Aspirin
Other Name: Aspirin protect or Astrix




Primary Outcome Measures :
  1. Coronary artery disease assessed by cardiac computed tomography angiography [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607436


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Soo Lim, MD, PhD SNUBH

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Responsible Party: Soo Lim, Associate Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02607436    
Other Study ID Numbers: B-1111/139-007
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Sarpogrelate
Serotonin
Serotonin Antagonists
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents