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Efficacy Study of Atorvastatin to Treat Variant Angina (ESAVA)

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ClinicalTrials.gov Identifier: NCT00620204
Recruitment Status : Unknown
Verified April 2009 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : February 21, 2008
Last Update Posted : April 6, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
The objective of this study is to evaluate effect of statin treatment for vasospastic angina.

Condition or disease Intervention/treatment Phase
Angina Pectoris, Variant Drug: atorvastatin Phase 4

Detailed Description:

Vasospastic angina is presented by myocardial ischemia with spasm of coronary artery accompanying chest pain or discomfort. The precise mechanisms have not been established, but a reduction in NO (nitric oxide) production, an imbalance between endothelium-derived relaxing and contracting factors,or an injury of endothelium have been suggested.

Impaired FMD(flow mediated endothelium-dependent vasodilation) in the brachial artery was demonstrated in vasospastic angina,and improvement of endothelial dysfunction with treatment of statin is documented in several studies.

So, we expect that statin treatment for vasospastic angina provide additional therapeutic effects via improvement of endothelial dysfunction.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy Study of Atorvastatin to Treat Variant Angina
Study Start Date : January 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2010


Arms and Interventions

Arm Intervention/treatment
Experimental: A
Atorvastatin group
Drug: atorvastatin
atorvastatin 40mg qd for 1 year
Other Name: Lipitor®
No Intervention: B
Control group


Outcome Measures

Primary Outcome Measures :
  1. Ergonovine provocation test 24hrs later after admission [ Time Frame: 1 year later ]

Secondary Outcome Measures :
  1. Chest pain with EKG change during admission for 24hrs at 12mo. later (All medications are withheld for 48hrs. before admission) [ Time Frame: 1year later ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Vasospastic angina or spontaneous spasm during coronary angiography (Vasospastic angina is defined as Thrombolysis In Myocardial Infarction (TIMI) flow grade 0-2 noted in intracoronary ergonovine provocation test and development of chest pain or EKG change; Spontaneous spasm is defined as TIMI flow grade 0-2 of coronary artery without ergonovine injection)
  • Normal or insignificant lesion (diameter stenosis <50%) on coronary angiography

Exclusion Criteria:

  • Elevated liver enzyme: serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
  • Significant lesion( diameter stenosis ≥50%) documented in coronary angiography
  • Pregnancy
  • Prior percutaneous coronary intervention or coronary artery bypass surgery
  • Previous statin use
  • Impaired renal function with serum creatinine ≥ 2.0 mg/dl
  • Severe left ventricular dysfunction ( LVEF ≤ 30% on echocardiography)
  • Myopathy
Contacts and Locations

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): NCT00620204


Contacts
Contact: Hyun-chul Gwon, MD,PhD 82-2-3410-3418 hcgwon@smc.samsung.co.kr

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Hyun-chul Gwon, MD,PhD Samsung Medical Center
More Information

Responsible Party: HC Gwon, MD,PhD / Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00620204     History of Changes
Other Study ID Numbers: 2008-01-018
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: April 6, 2009
Last Verified: April 2009

Keywords provided by Samsung Medical Center:
atorvastatin
Angina Pectoris, Variant
endothelial dysfunction

Additional relevant MeSH terms:
Angina Pectoris
Angina Pectoris, Variant
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms
Angina, Unstable
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors