Efficacy Study of Atorvastatin to Treat Variant Angina (ESAVA)

Samsung Medical Center

Status and phase: Unknown; Phase 4

Conditions: Angina Pectoris, Variant

Treatments: Drug: atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00620204

2008-01-018

Details and patient eligibility

About

The objective of this study is to evaluate effect of statin treatment for vasospastic angina.

Full 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.

Enrollment: 136 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

136 participants in 2 patient groups

A

Experimental group

Description:

Atorvastatin group

Treatment:

Drug: atorvastatin

B

No Intervention group

Description:

Control group