deltatrials
Terminated INTERVENTIONAL NCT03228238

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

Conditions Variant Angina
Updated 8 times since 2017 Last updated: Apr 22, 2026 Started: Sep 1, 2014 Primary completion: Jun 1, 2024 Completion: Jun 1, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The study was terminated early due to slow recruitment and the Principal Investigator's retirement.

A observational or N/A phase clinical study on Variant Angina, this trial is terminated or withdrawn.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

~Aug 2017 – ~Jun 2018 · 10 months · monthly snapshotRecruiting~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotRecruiting~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotRecruiting~Oct 2021 – ~Jul 2024 · 33 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotUnknown~Sep 2025 – ~Apr 2026 · 8 months · monthly snapshotUnknownApr 28, 2026 – present · 2 months · daily APITerminated

Change History

8 versions recorded
  1. Apr 28, 2026 — Present [daily]

    Terminated

    Status: UnknownTerminated · Phase: PHASE4None

  2. Sep 2025 — Apr 2026 [monthly]

    Unknown PHASE4

  3. Sep 2024 — Sep 2025 [monthly]

    Unknown PHASE4

  4. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE4

    Status: Unknown StatusUnknown

  5. Oct 2021 — Jul 2024 [monthly]

    Unknown Status PHASE4

    Status: RecruitingUnknown Status

Show 3 earlier versions
  1. Jan 2021 — Oct 2021 [monthly]

    Recruiting PHASE4

  2. Jun 2018 — Jan 2021 [monthly]

    Recruiting PHASE4

  3. 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

Sponsor contact:
  • Seoul National University Hospital
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations