ANti-Oxidant in Variant Angina (ANOVA) Trial
Effects of Long-term Vitamin C+E and Statin Therapy on Vasospasm Improvement and Regression of Atheroma in Patients With Variant Angina
Sponsor: Seoul National University Hospital
Terminated
The study was terminated early due to slow recruitment and the Principal Investigator's retirement.
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See all terminations from Seoul National University Hospital
A observational or N/A phase clinical study on Variant Angina, this trial is terminated or withdrawn. The trial is conducted by Seoul National University Hospital and has accumulated 8 data snapshots since 2014. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)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...
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 Flow
Change History
8 versions recorded-
Apr 28, 2026 — Present [daily]
Terminated
Status: Unknown → Terminated · Phase: PHASE4 → None
-
Sep 2025 — Apr 2026 [monthly]
Unknown PHASE4
-
Sep 2024 — Sep 2025 [monthly]
Unknown PHASE4
-
Jul 2024 — Sep 2024 [monthly]
Unknown PHASE4
Status: Unknown Status → Unknown
-
Oct 2021 — Jul 2024 [monthly]
Unknown Status PHASE4
Status: Recruiting → Unknown Status
▶ Show 3 earlier versions
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Jan 2021 — Oct 2021 [monthly]
Recruiting PHASE4
-
Jun 2018 — Jan 2021 [monthly]
Recruiting PHASE4
-
Aug 2017 — Jun 2018 [monthly]
Recruiting PHASE4
First recorded
Sep 2014
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility 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)
Contact Information
- Seoul National University Hospital
For direct contact, visit the study record on ClinicalTrials.gov .