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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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)

Detailed description

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.

Conditions

• Variant Angina

Interventions

Type	Name	Description
DRUG	Vitamin C and Vitamin E	Ascorbic acid Tablet 1g and Tocopherol Capsule 400IU
DRUG	Statin	Atorvastatin calcium 10mg
DRUG	Standard medication for variant angina	Calcium Channel blocker or NG

Timeline

• Start date: 2014-09-01
• Primary completion: 2020-09-01
• Completion: 2021-02-28
• First posted: 2017-07-24
• Last updated: 2017-07-24

Locations

1 site across 1 country: South Korea