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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00693589
First Posted: June 9, 2008
Last Update Posted: June 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Inselspital, Berne
  Purpose
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.

Condition Intervention Phase
Cardiovascular Disease Endothelial Dysfunction Drug: folic acid, vitamin B12 and B6 and rosuvastatin Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Flow mediated dilatation (FMD) [ Time Frame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment ]

Secondary Outcome Measures:
  • changes in biochemistry parameters [ Time Frame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment ]

Enrollment: 36
Study Start Date: January 2005
Study Completion Date: April 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: R
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
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

Detailed Description:
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.
  Eligibility

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

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
  Contacts and Locations
Information from the National Library of Medicine

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


Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Study Director: Kerstin Wustmann, MD Cardiology, Inselspital, University hospital Bern
Study Chair: Yves Allemann, MD Cardiology, Inselspital, University hospital Bern
  More Information

Responsible Party: Allemann, Y., MD, Cardiology, Inselspital Berne
ClinicalTrials.gov Identifier: NCT00693589     History of Changes
Other Study ID Numbers: KEK-Nr. 115/03
First Submitted: June 5, 2008
First Posted: June 9, 2008
Last Update Posted: June 9, 2008
Last Verified: June 2008

Keywords provided by University Hospital Inselspital, Berne:
endothelial function
flow mediated dilatation
rosuvastatin
folic acid
B vitamins

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vitamins
Folic Acid
Vitamin B 12
Hydroxocobalamin
Vitamin B 6
Pyridoxal
Pyridoxine
Rosuvastatin Calcium
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Hematinics