Effect of Homocysteine-Lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-Dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease

Study Overview
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Brief Summary
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Endothelial dysfunction is an early marker of atherosclerosis and is found in patients (pts) with coronary (CAD) and peripheral artery disease (PAD). Statin-therapy has been shown to improve endothelial function in pts with CAD or PAD by reducing LDL-cholesterol and inflammatory markers. B-group vitamin-supplements have variable been reported to have positive or neutral effects on endothelial function. Therefore, we want to compare the effect of rosuvastatin and B-group vitamin supplementation on endothelial function of the forearm resistance vessels in pts with cardiovascular disease.

Detailed Description
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Study design: 36 pts with CAD or PAD are randomly assigned to either rosuvastatin 10mg/d or vitamin supplementation with folic acid 1mg, vitamin B12 0.4mg and B6 10mg/d for 6 weeks in a double-blinded design. After 6 weeks all pts receive rosuvastatin and vitamin supplementation in combination for additional 6 weeks.

Official Title
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Effect of Homocysteine-Lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-Dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease

Conditions
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Cardiovascular Disease, Endothelial Dysfunction

Intervention / Treatment
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* Drug: folic acid, vitamin B12 and B6 and rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CAD or PAD (>50% luminal stenosis), previous myocardial infarction or bypass surgery >3 month ago history of percutaneous coronary intervention (PTCA or stenting) confirmed consent Exclusion Criteria: myocardial infarction or acute coronary syndrome or bypass surgery <3 month ago ongoing treatment with statins ongoing vitamin supplementation with folic acid and B vitamins <18 years active smokers uncontrolled arterial hypertension renal insufficiency atrial fibrillation liver disease NYHA class >2 familial hypercholesterolemia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: R<br>Rosuvastatin treatment for 6 weeks and after that combined treatment with rosuvastatin and vitamin supplementation for additional 6 weeks | Drug: folic acid, vitamin B12 and B6 and rosuvastatin<br>* Vitamin supplementation with folic acid 1mg/d, vitamin B12 0.4mg/d and B6 10mg/d po for 6 weeks alone vs. rosuvastatin 10mg/d for 6 weeks alone and thereafter combined treatment for 6 weeks<br>* Other names: Crestor;|
| Active Comparator: V<br>Vitamin supplementation with folic acid, vitamin B12 and B6 for 6 weeks and after that combined treatment with vitamin supplementation and rosuvastatin | Drug: folic acid, vitamin B12 and B6 and rosuvastatin<br>* Vitamin supplementation with folic acid 1mg/d, vitamin B12 0.4mg/d and B6 10mg/d po for 6 weeks alone vs. rosuvastatin 10mg/d for 6 weeks alone and thereafter combined treatment for 6 weeks<br>* Other names: Crestor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow mediated dilatation (FMD) |  | after 6 weeks of randomized treatment and after 6 weeks of combined treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in biochemistry parameters |  | after 6 weeks of randomized treatment and after 6 weeks of combined treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelial function, flow mediated dilatation, rosuvastatin, folic acid, B vitamins