Variant Angina Clinical Trial
Official title:
Effects of Long-term Vitamin C+E and Statin Therapy on Vasospasm Improvement and Regression of Atheroma in Patients With Variant Angina
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)
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 patients with variant angina.
After provocation test, patients will be classified into three groups.(See below)
1. Negative group : Patients who have symptoms that are consistent with vasospastic angina
but only show luminal narrowing less than 50% on coronary angiography during provocation
test.
2. Mild Spastic group : Patients who have symptoms that are consistent with vasospastic
angina and show luminal narrowing over 50% to less than 90% on coronary angiography
during provocation test.
3. Severe Spastic group : Patients who have symptoms that are consistent with vasospastic
angina and show luminal narrowing over 90% on coronary angiography during provocation
test.
In each group (except for patient in Negative group), patients will be randomized in a two by
two factorial manner according to the study drug therapy (Vitamin C+E vs. no Vitamin C+E)
(Statin vs. no Statin) As a result, patients in each group(except for patient in Negative
group) will be randomized to 4 treatment subgroups, which are
1. Control subgroup : Standard medication for Variant angina only
2. Vitamin subgroup : Standard medication + Vitamin C+E
3. Statin subgroup : Standard medication + Statin
4. Dual subgroup : Standard medication + Vitamin C+E + Statin
Patients in Negative group will be prescribed only for standard medication for variant
angina.
Patient Enrollment: Recruiting 300 patients(100 patients for each group, as 25 patients for
each subgroups) from September 2014 through February 2021 at single center in Korea(Seoul
National University Hospital)
Patient Follow-Up: Clinical follow-up will occur at 1, and 6 months, and at 2, 4, and 6
years. Investigator or designee may conduct follow-up as telephone contacts or office visits.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 2 | |
| Recruiting |
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Phase 4 |