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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
History of Changes
  Purpose

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: Open Label
Primary Purpose: Treatment
Official Title: Efficacy Study of Atorvastatin to Treat Variant Angina

Resource links provided by NLM:

MedlinePlus related topics: Angina
U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Ergonovine provocation test 24hrs later after admission [ Time Frame: 1 year later ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: HC Gwon, MD,PhD / Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00620204     History of Changes
Other Study ID Numbers: 2008-01-018
Study First Received: February 10, 2008
Last Updated: April 2, 2009
Health Authority: South Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 21, 2013