Efficacy Study of Atorvastatin to Treat Variant Angina (ESAVA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00620204
First received: February 10, 2008
Last updated: April 2, 2009
Last verified: April 2009

February 10, 2008
April 2, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00620204 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
136
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
Both
Not Provided
No
Contact: Hyun-chul Gwon, MD,PhD 82-2-3410-3418 hcgwon@smc.samsung.co.kr
Korea, Republic of
 
NCT00620204
2008-01-018
No
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