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Efficacy Study of Atorvastatin to Treat Variant Angina (ESAVA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by Samsung Medical Center.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: February 21, 2008
Last Update Posted: April 6, 2009
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.
Information provided by:
Samsung Medical Center
The objective of this study is to evaluate effect of statin treatment for vasospastic angina.

Condition Intervention Phase
Angina Pectoris, Variant Drug: atorvastatin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy Study of Atorvastatin to Treat Variant Angina

Resource links provided by NLM:

Further study details as provided by Samsung Medical Center:

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

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

Estimated Enrollment: 136
Study Start Date: January 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Atorvastatin group
Drug: atorvastatin
atorvastatin 40mg qd for 1 year
Other Name: Lipitor®
No Intervention: B
Control group

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.


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

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

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

Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
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 Submitted: February 10, 2008
First Posted: February 21, 2008
Last Update Posted: April 6, 2009
Last Verified: April 2009

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

Additional relevant MeSH terms:
Angina Pectoris
Angina Pectoris, Variant
Chest 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
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors