Efficacy Study of Atorvastatin to Treat Variant Angina

Study Overview
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Brief Summary
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The objective of this study is to evaluate effect of statin treatment for vasospastic angina.

Detailed Description
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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.

Official Title
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Efficacy Study of Atorvastatin to Treat Variant Angina

Conditions
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Angina Pectoris, Variant

Intervention / Treatment
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* Drug: atorvastatin


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Atorvastatin group | Drug: atorvastatin<br>* atorvastatin 40mg qd for 1 year<br>* Other names: Lipitor®;|
| No Intervention: B<br>Control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ergonovine provocation test 24hrs later after admission |  | 1 year later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest pain with EKG change during admission for 24hrs at 12mo. later (All medications are withheld for 48hrs. before admission) |  | 1year later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atorvastatin, Angina Pectoris, Variant, endothelial dysfunction