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
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ClinicalTrials.gov Identifier: NCT00693589 |
Recruitment Status :
Completed
First Posted : June 9, 2008
Last Update Posted : June 9, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cardiovascular Disease Endothelial Dysfunction | Drug: folic acid, vitamin B12 and B6 and rosuvastatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 Start Date : | January 2005 |
Actual Primary Completion Date : | February 2007 |
Actual Study Completion Date : | April 2007 |

Arm | Intervention/treatment |
---|---|
Active Comparator: R
Rosuvastatin treatment for 6 weeks and after that combined treatment with rosuvastatin and vitamin supplementation for additional 6 weeks
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Drug: folic acid, vitamin B12 and B6 and rosuvastatin
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
Other Name: Crestor |
Active Comparator: V
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
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
Other Name: Crestor |
- Flow mediated dilatation (FMD) [ Time Frame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment ]
- changes in biochemistry parameters [ Time Frame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693589
Study Director: | Kerstin Wustmann, MD | Cardiology, Inselspital, University hospital Bern | |
Study Chair: | Yves Allemann, MD | Cardiology, Inselspital, University hospital Bern |
Responsible Party: | Allemann, Y., MD, Cardiology, Inselspital Berne |
ClinicalTrials.gov Identifier: | NCT00693589 |
Other Study ID Numbers: |
KEK-Nr. 115/03 |
First Posted: | June 9, 2008 Key Record Dates |
Last Update Posted: | June 9, 2008 |
Last Verified: | June 2008 |
endothelial function flow mediated dilatation rosuvastatin folic acid B vitamins |
Cardiovascular Diseases Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Folic Acid Vitamin B 12 Hydroxocobalamin Rosuvastatin Calcium Vitamins |
Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Hematinics Vitamin B Complex |