Status:
COMPLETED
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
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Cardiovascular Disease
Endothelial Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 endotheli...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00693589
Start Date
January 1 2005
End Date
April 1 2007
Last Update
November 7 2024
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