Efficacy Study of Atorvastatin to Treat Variant Angina (ESAVA)

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. 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
Information provided by:
Samsung Medical Center

February 10, 2008
February 21, 2008
April 6, 2009
January 2008
December 2009   (Final data collection date for primary outcome measure)
Ergonovine provocation test 24hrs later after admission [ Time Frame: 1 year later ]
Same as current
Complete list of historical versions of study NCT00620204 on Archive Site
Chest pain with EKG change during admission for 24hrs at 12mo. later (All medications are withheld for 48hrs. before admission) [ Time Frame: 1year later ]
Same as current
Not Provided
Not Provided
Efficacy Study of Atorvastatin to Treat Variant Angina
Efficacy Study of Atorvastatin to Treat Variant Angina
The objective of this study is to evaluate effect of statin treatment for vasospastic angina.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Angina Pectoris, Variant
Drug: atorvastatin
atorvastatin 40mg qd for 1 year
Other Name: Lipitor®
  • Experimental: A
    Atorvastatin group
    Intervention: Drug: atorvastatin
  • No Intervention: B
    Control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2010
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
Not Provided
Not Provided
HC Gwon, MD,PhD / Professor, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Hyun-chul Gwon, MD,PhD Samsung Medical Center
Samsung Medical Center
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP