Angina Pectoris, Variant
Conditions
Keywords
atorvastatin, Angina Pectoris, Variant, endothelial dysfunction
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.
Interventions
DRUGatorvastatin
atorvastatin 40mg qd for 1 year
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ergonovine provocation test 24hrs later after admission | 1 year later |
Secondary
| Measure | Time frame |
|---|---|
| Chest pain with EKG change during admission for 24hrs at 12mo. later (All medications are withheld for 48hrs. before admission) | 1year later |
Countries
South Korea
Contacts
Primary ContactHyun-chul Gwon, MD,PhD
Outcome results
None listed