Status:
UNKNOWN
ANti-Oxidant in Variant Angina (ANOVA) Trial
Lead Sponsor:
Seoul National University Hospital
Conditions:
Variant Angina
Eligibility:
All Genders
30+ years
Phase:
PHASE4
Brief Summary
Purpose Objectives 1. To evaluate the anti-oxidant effect of long-term Vitamin C+E therapy on coronary vasospasm improvement. 2. To evaluate the anti-oxidant effect of long-term statin therapy on cor...
Detailed Description
Study Design: Prospective, open label, Four-arm, randomized single-center trial to test the effect long-term Vitamin C+E and Statin therapy on vasospasm improvement and regression of atheroma in patie...
Eligibility Criteria
Inclusion
- Subject must be at least 30 years of age.
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the Vitamin C+E or Statin or Dual, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- Subject must have symptoms that are consistent with vasospastic angina with planned Coronary angiography and Provocation test.
Exclusion
- Patient who has organic coronary stenosis in main coronary branch at least 50% luminal narrowing after intracoronary nitroglycerin injection
- Patient who has continuously taken Vitamin C or Vitamin E or Statin within 3months before Admission
- Creatinine level ≥ 2.0mg/dL or dependence on dialysis.
- Severe hepatic dysfunction (AST and ALT: 3 times upper normal reference values).
- Active Myopathy or elevated Creatine kinase enzyme level (3 times upper normal reference values).
- History of Severe hepatic dysfunction or Rhabdomyolysis due to statin side effect
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- History of Urolithiasis
- Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2021
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03228238
Start Date
September 1 2014
End Date
February 28 2021
Last Update
July 24 2017
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea