search
Back to results

Efficacy Study of Atorvastatin to Treat Variant Angina (ESAVA)

Primary Purpose

Angina Pectoris, Variant

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
atorvastatin
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angina Pectoris, Variant focused on measuring atorvastatin, Angina Pectoris, Variant, endothelial dysfunction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A

B

Arm Description

Atorvastatin group

Control group

Outcomes

Primary Outcome Measures

Ergonovine provocation test 24hrs later after admission

Secondary Outcome Measures

Chest pain with EKG change during admission for 24hrs at 12mo. later (All medications are withheld for 48hrs. before admission)

Full Information

First Posted
February 10, 2008
Last Updated
April 2, 2009
Sponsor
Samsung Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00620204
Brief Title
Efficacy Study of Atorvastatin to Treat Variant Angina
Acronym
ESAVA
Official Title
Efficacy Study of Atorvastatin to Treat Variant Angina
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris, Variant
Keywords
atorvastatin, Angina Pectoris, Variant, endothelial dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Atorvastatin group
Arm Title
B
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Other Intervention Name(s)
Lipitor®
Intervention Description
atorvastatin 40mg qd for 1 year
Primary Outcome Measure Information:
Title
Ergonovine provocation test 24hrs later after admission
Time Frame
1 year later
Secondary Outcome Measure Information:
Title
Chest pain with EKG change during admission for 24hrs at 12mo. later (All medications are withheld for 48hrs. before admission)
Time Frame
1year later

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun-chul Gwon, MD,PhD
Phone
82-2-3410-3418
Email
hcgwon@smc.samsung.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun-chul Gwon, MD,PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of Atorvastatin to Treat Variant Angina

We'll reach out to this number within 24 hrs