Efficacy Study of Atorvastatin to Treat Variant Angina
ESAVA
1 other identifier
interventional
136
1 country
1
Brief Summary
The objective of this study is to evaluate effect of statin treatment for vasospastic angina.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 10, 2008
CompletedFirst Posted
Study publicly available on registry
February 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedApril 6, 2009
April 1, 2009
1.9 years
February 10, 2008
April 2, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ergonovine provocation test 24hrs later after admission
1 year later
Secondary Outcomes (1)
Chest pain with EKG change during admission for 24hrs at 12mo. later (All medications are withheld for 48hrs. before admission)
1year later
Study Arms (2)
A
EXPERIMENTALAtorvastatin group
B
NO INTERVENTIONControl group
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyun-chul Gwon, MD,PhD
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 10, 2008
First Posted
February 21, 2008
Study Start
January 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2010
Last Updated
April 6, 2009
Record last verified: 2009-04