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The Effect of Sarpogrelate and High Dose Statin on the Reduction of Coronary Spasm

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ClinicalTrials.gov Identifier: NCT01674686
Recruitment Status : Recruiting
First Posted : August 29, 2012
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Hyeon-Cheol Gwon, Samsung Medical Center

Brief Summary:
The aim of the study was to to evaluate the effect of sarpogrelate, a selective serotonin receptor antagonist, and high dose statin on the reduction of coronary spasm in the patients with variant angina.

Condition or disease Intervention/treatment Phase
Variant Angina Drug: Sarpogrelate Drug: Atorvastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective, Single-center, Randomized Study to Evaluate the Effect of Sarpogrelate, a Selective Serotonin Receptor Antagonist, and High Dose Statin on the Reduction of Coronary Spasm in the Patients With Variant Angina
Actual Study Start Date : August 1, 2012
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018


Arm Intervention/treatment
Experimental: A
Sarpogrelate versus placebo
Drug: Sarpogrelate
Sarpogrelate 100mg twice a day

Experimental: B
Atorvastatin 80mg versus no statin or simvastatin 20 mg if LDL > 130 mg/dl
Drug: Atorvastatin
Atorvastatin 80mg daily




Primary Outcome Measures :
  1. Ergonovine provocation test 12months later [ Time Frame: 1 year later ]

Secondary Outcome Measures :
  1. C-reactive protein lever 12months later [ Time Frame: 1 year ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical history of chest pain compatible with variant angina; morning chest pain aggravated by cold exposure.
  • Angiographically proven coronary spasm; TIMI flow < 3 by spontaneous coronary spasm or intracoronary ergonovine spasm provocation test.

Exclusion Criteria:

  • Cardiac arrest by coronary spasm
  • Left main coronary spasm
  • Significant fixed coronary artery stenosis; Diameter stenosis > 70% in the major epicardial artery by coronary angiography
  • Left ventricular ejection fraction < 30%
  • Coagulation disorders or bleeding tendency (Platelet count < 50k, PT INR > 2.0)
  • Significant liver disease (AST or ALT > 100 U/ml)
  • Renal failure (S-Cr > 2.0 mg/dl)
  • hypersensitivity for statin
  • Pregnancy

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): NCT01674686


Contacts
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Contact: Hyeon-Cheol Gwon, MD,PhD 82-2-3410-3419 hcgwon@skku.edu
Contact: Jeong Hoon Yang, MD 82-2-3410-3419 jhysmc@gmail.com

Locations
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Korea, Republic of
Hyoen-Cheol Gwon, MD,PhD Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Hyoen-Cheol Gwon, MD,PhD    82-2-3410-3418    hcgwon@skku.edu   
Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: Hyeon-Cheol Gwon, professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01674686     History of Changes
Other Study ID Numbers: 2011-12-069
First Posted: August 29, 2012    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Keywords provided by Hyeon-Cheol Gwon, Samsung Medical Center:
Vasospasm
Sarpogrelate
Statin

Additional relevant MeSH terms:
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Angina Pectoris, Variant
Coronary Vasospasm
Angina, Unstable
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Coronary Disease
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Sarpogrelate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors
Fibrinolytic Agents
Fibrin Modulating Agents
Platelet Aggregation Inhibitors
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs