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The study was terminated early due to slow recruitment and the Principal Investigator's retirement.
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Purpose Objectives
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)
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Statin subgroup | Experimental | Standard medication for variant angina plus Statin Statin : Atorvastatin calcium 10mg |
|
| Vitamin subgroup | Experimental | Standard medication for variant angina plus Vitamin C+E Vitamin C and Vitamin E : Ascorbic acid Tablet 1g / Tocopherol Capsule 400IU |
|
| Control group | Active Comparator | Control subgroup : Standard medication for Variant angina only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C and Vitamin E | Drug | Ascorbic acid Tablet 1g and Tocopherol Capsule 400IU |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in Vasospasm | Changes of Vasospasm in Control subgroup, Vitamin subgroup, Statin subgroup, and Dual subgroup compared to baseline vasospasm assessed by provocation test. | at 6 months, and at 2, 4, and 6 years follow up period |
| Composed improvement of Vascular endothelial function(Brachial arterial expansion capability) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyo-Soo Kim, Kim | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000788 | Angina Pectoris, Variant |
| ID | Term |
|---|---|
| D000789 | Angina, Unstable |
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D014810 | Vitamin E |
| D024505 | Tocopherols |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| D000069059 | Atorvastatin |
| D002121 | Calcium Channel Blockers |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Statin | Drug | Atorvastatin calcium 10mg |
|
|
| Standard medication for variant angina | Drug | Calcium Channel blocker or NG |
|
|
in Vitamin subgroup, Statin subgroup, and Dual subgroup compared to control subgroup |
| at 6 months, and at 2, 4, and 6 years follow up period |
| Improvement of Vascular endothelial function(Brachial arterial expansion capability) | in Vitamin subgroup, Statin subgroup, and Dual subgroup compared to baseline endothelial function test results | 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) | in Vitamin subgroup, Statin subgroup, and Dual subgroup | at 6 months, and at 2, 4, and 6 years follow up period |
| Composed improvement of Arterial stiffness(Pulse wave velocity(PWV)) | in Vitamin subgroup, Statin subgroup, and Dual subgroup compared to control subgroup | at 6 months, and at 2, 4, and 6 years follow up period |
| Improvement of Arterial stiffness(Pulse wave velocity(PWV)) | in Vitamin subgroup, Statin subgroup, and Dual subgroup compared to baseline endothelial function test results | at 6 months, and at 2, 4, and 6 years follow up period |
| Comparative analysis of improvement of Arterial stiffness(Pulse wave velocity(PWV)) | in Vitamin subgroup, Statin subgroup, and Dual subgroup | at 6 months, and at 2, 4, and 6 years follow up period |
| D002318 |
| Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D049990 | Membrane Transport Modulators |
| D000077264 | Calcium-Regulating Hormones and Agents |
| D045505 | Physiological Effects of Drugs |
| D002317 | Cardiovascular Agents |