Efficacy Study of Atorvastatin to Treat Variant Angina

Angina Pectoris, Variant Clinical Trial

— ESAVA  

Official title:

Efficacy Study of Atorvastatin to Treat Variant Angina

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00620204
• Other study ID #: 2008-01-018
• Status: Recruiting
• Phase: Phase 4
• First received: February 10, 2008
• Last updated: April 2, 2009
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: April 2009
• Source: Samsung Medical Center
• Contact: Hyun-chul Gwon, MD,PhD
• Phone: 82-2-3410-3418
• Email: hcgwon[@]smc.samsung.co.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Angina Pectoris, Variant

Intervention

Drug:
• atorvastatin
atorvastatin 40mg qd for 1 year

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ergonovine provocation test 24hrs later after admission		1 year later	No
Secondary	Chest pain with EKG change during admission for 24hrs at 12mo. later (All medications are withheld for 48hrs. before admission)		1year later	No