Efficacy Study of Atorvastatin to Treat Variant Angina - Full Text View

Sponsored by:	Samsung Medical Center
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00620204

Purpose

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

Condition	Intervention	Phase
Angina Pectoris, Variant	Drug: atorvastatin	Phase IV

MedlinePlus related topics: Angina

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Efficacy Study of Atorvastatin to Treat Variant Angina

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

Ergonovine provocation test 24hrs later after admission [ Time Frame: 1 year later ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Chest pain with EKG change during admission for 24hrs at 12mo. later (All medications are withheld for 48hrs. before admission) [ Time Frame: 1year later ] [ Designated as safety issue: No ]

Estimated Enrollment:	136
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Atorvastatin group	Drug: atorvastatin atorvastatin 40mg qd for 1 year
B: No Intervention Control group

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620204

Contacts

Contact: Hyun-chul Gwon, MD,PhD

82-2-3410-3418

hcgwon@smc.samsung.co.kr

Locations

Korea, Republic of
Samsung Medical Center	Recruiting
Seoul, Korea, Republic of

Sponsors and Collaborators

Samsung Medical Center

Investigators

Principal Investigator:

Hyun-chul Gwon, MD,PhD

Samsung Medical Center

More Information

Responsible Party:	Samsung Medical Center ( HC Gwon, MD,PhD / Professor )
Study ID Numbers:	2008-01-018
Study First Received:	February 10, 2008
Last Updated:	February 10, 2008
ClinicalTrials.gov Identifier:	NCT00620204
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:

atorvastatin
Angina Pectoris, Variant
endothelial dysfunction

Study placed in the following topic categories:

Signs and Symptoms
Heart Diseases
Angina Pectoris, Variant
Myocardial Ischemia
Prinzmetal's variant angina
Vascular Diseases

Angina Pectoris
Pain
Ischemia
Angina, Unstable
Atorvastatin
Chest Pain

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009