ANti-Oxidant in Variant Angina (ANOVA) Trial

NCT03228238 | Terminated Phase 4

• 1 other identifier: ANOVA
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose Objectives

1. 1.To evaluate the anti-oxidant effect of long-term Vitamin C+E therapy on coronary vasospasm improvement.
2. 2.To evaluate the anti-oxidant effect of long-term statin therapy on coronary vasospasm improvement.
3. 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. 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. 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)

Conditions

Variant Angina

Outcome Measures

Primary Outcomes (4)

• Vasospasm at 6months

  Severity of vasospasm in Vitamin subgroup, Statin subgroup, and Dual subgroup compared to control subgroup.

  at 6 months

• Vasospasm at 2 years

  Severity of vasospasm in Vitamin subgroup, Statin subgroup, and Dual subgroup compared to control subgroup.

  at 2 years

• Vasospasm at 4 years

  Severity of vasospasm in Vitamin subgroup, Statin subgroup, and Dual subgroup compared to control subgroup.

  at 4 years

• Vasospasm at 6 years

  Severity of vasospasm in Vitamin subgroup, Statin subgroup, and Dual subgroup compared to control subgroup.

  at 6 years

Secondary Outcomes (7)

• Changes from baseline in Vasospasm

  at 6 months, and at 2, 4, and 6 years follow up period

• Composed improvement of Vascular endothelial function(Brachial arterial expansion capability)

  at 6 months, and at 2, 4, and 6 years follow up period

• Improvement of Vascular endothelial function(Brachial arterial expansion capability)

  at 6 months, and at 2, 4, and 6 years follow up period

• Comparative analysis of improvement of Vascular endothelial function(Brachial arterial expansion capability)

  at 6 months, and at 2, 4, and 6 years follow up period

• Composed improvement of Arterial stiffness(Pulse wave velocity(PWV))

  at 6 months, and at 2, 4, and 6 years follow up period

Study Arms (4)

Dual subgroup

EXPERIMENTAL

Standard medication for variant angina plus Vitamin C+E plus Statin Vitamin C and Vitamin E : Ascorbic acid Tablet 1g / Tocopherol Capsule 400IU Statin : Atorvastatin calcium 10mg

Drug: Vitamin C and Vitamin E; Drug: Statin; Drug: Standard medication for variant angina

Statin subgroup

EXPERIMENTAL

Standard medication for variant angina plus Statin Statin : Atorvastatin calcium 10mg

Drug: Statin; Drug: Standard medication for variant angina

Vitamin subgroup

EXPERIMENTAL

Standard medication for variant angina plus Vitamin C+E Vitamin C and Vitamin E : Ascorbic acid Tablet 1g / Tocopherol Capsule 400IU

Drug: Vitamin C and Vitamin E; Drug: Standard medication for variant angina

Control group

ACTIVE COMPARATOR

Control subgroup : Standard medication for Variant angina only

Drug: Standard medication for variant angina

Interventions

Vitamin C and Vitamin E DRUG

Ascorbic acid Tablet 1g and Tocopherol Capsule 400IU

Also known as: Ascorbic acid and Tocopherol

Dual subgroup; Vitamin subgroup

Statin DRUG

Atorvastatin calcium 10mg

Also known as: Atorvastatin

Dual subgroup; Statin subgroup

Standard medication for variant angina DRUG

Calcium Channel blocker or NG

Also known as: Calcium Channel blocker or NG

Control group; Dual subgroup; Statin subgroup; Vitamin subgroup

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Angina Pectoris, Variant

Interventions

Ascorbic Acid; Vitamin E; Tocopherols; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Calcium Channel Blockers

Condition Hierarchy (Ancestors)

Angina, Unstable; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Cardiovascular Agents

Study Officials

• Hyo-Soo Kim, Kim

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiac Catheterization Laboratory & Coronary Intervention

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 24, 2017
• Study Start: September 1, 2014
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

KR (1)