Clinical Trial: Comparison of Phenprocoumon and Acetylsalicylic Acid (ASA)
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Prospective Comparison of Phenprocoumon (Marcumar) and Acetylsalicylic Acid (ASA)With Regard to the Progress of Valvular and Coronary Calcification
Brief Summary: In this open, prospective, non-randomised, parallel group, unicentric pilot-study will be compared the progress of valvular and coronary calcification with regard to the therapy with either acetyl-salicylic acid or phenprocoumon. The progress of calcification is documented by comparison of cardial stratified computed tomography. It is supposed that treatment with phenprocumon leads to increased coronary and valvular calcification as well to decreased blood levels of carboxylated matrix-GLA-protein
Detailed Summary:
Patients will be allocated to two groups with either
- anticoagulation with phenprocoumon (needed for at least 1 year)
- therapy with ASA
Both treatment groups should include to 50% patients with a glomerular filtration rate (GFR) < 60 ml/min and > 15 ml/min.
All patients will undergo a screening procedure with evaluation of calcium regulating proteins, echocardiography and stratified computed tomography of the heart. Medical check up's are planned after 1,3,6, 12 and 18 months.
Prior investigations concern diastolic ventricular function under long lasting therapy with phenprocoumon and the influence of long lasting therapy with phenprocoumon in patients suffering from aortic valve sclerosis.
Sponsor: RWTH Aachen University
Current Primary Outcome: Progression of coronary and valvular calcification confirmed by computed tomography [ Time Frame: 18 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Measurement of inhibitors of calcification and biomarkers for inflammation (blood samples), evaluation of the haemodynamic progress as well as dyastolic dysfunction (echocardiography) [ Time Frame: 18 months ]
Original Secondary Outcome: Same as current
Information By: RWTH Aachen University
Dates:
Date Received: October 29, 2008
Date Started: February 2008
Date Completion:
Last Updated: September 22, 2015
Last Verified: September 2015
