Status:
UNKNOWN
Efficacy Study of Atorvastatin to Treat Variant Angina
Lead Sponsor:
Samsung Medical Center
Conditions:
Angina Pectoris, Variant
Eligibility:
All Genders
Phase:
PHASE4
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 (nit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00620204
Start Date
January 1 2008
End Date
December 1 2010
Last Update
April 6 2009
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea