Efficacy Study of Atorvastatin to Treat Variant Angina

Phase 4

• Conditions: Angina Pectoris, Variant
• Interventions: Drug: atorvastatin

• Registration Number: NCT00620204
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-10
• Study First Submitted QC: 2008-02-10
• Study First Posted: 2008-02-21
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-02
• Last Update Posted: 2009-04-06
• Primary Completion: 2009-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	atorvastatin	Atorvastatin group

Primary Outcome Measures

Name	Time	Method
Ergonovine provocation test 24hrs later after admission	1 year later

Secondary Outcome Measures

Name	Time	Method
Chest pain with EKG change during admission for 24hrs at 12mo. later (All medications are withheld for 48hrs. before admission)	1year later

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of