Stopped: The study was terminated early due to slow recruitment and the Principal Investigator's retirement.
South Korea320 participantsStarted 2014-09-01
Plain-language 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 coronary vasospasm improvement.
3. To evaluate the effect of long-term Vitamin C+E and statin therapy on regression of atheroma in target coronary vessels via intravascular ultrasound.
4. To find out the role of vascular endothelium in variant angina via evaluating long-term Vitamin C+E and statin therapy on improvement in vascular endothelial function by assessing brachial arterial expansion capability.
5. To find out the role of vascular endothelium in variant angina via evaluating long-term Vitamin C+E and statin therapy on improvement in arterial stiffness by assessing pulse wave velocity(PWV)
Who can participate
Age range30 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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.