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 - Full Text View

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: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: B Vitamins Coronary Artery Disease Folic Acid Heart Diseases

Drug Information available for: Pyridoxine hydrochloride Folic acid Pyridoxine Cyanocobalamin Vitamin B Complex Cobalamin Hydroxocobalamin Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

changes in biochemistry parameters [ Time Frame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment ] [ Designated as safety issue: No ]


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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	June 5, 2008
Last Updated:	June 6, 2008
Health Authority:	Switzerland: Swissmedic

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 Vitamin B 12 Hydroxocobalamin Folic Acid Vitamin B 6 Pyridoxal	Pyridoxine Vitamin B Complex Rosuvastatin Calcium Micronutrients Growth Substances Physiological Effects of Drugs Hematinics Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents

ClinicalTrials.gov processed this record on September 26, 2016