Efficacy Study of Atorvastatin to Treat Variant Angina

Phase 4UnknownNCT00620204

Samsung Medical Center136 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

136

Conditions

Angina Pectoris, Variant

Interventions

atorvastatinDRUG

atorvastatin 40mg qd for 1 year

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Ergonovine provocation test 24hrs later after admission

Time frame: 1 year later

Secondary Outcomes

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

Time frame: 1year later

Central Contacts

Hyun-chul Gwon, MD,PhD

CONTACT

82-2-3410-3418 hcgwon@smc.samsung.co.kr

Data from ClinicalTrials.gov

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