Comparison of Phenprocoumon and Acetylsalicylic Acid (ASA)
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
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective Comparison of Phenprocoumon (Marcumar) and Acetylsalicylic Acid (ASA)With Regard to the Progress of Valvular and Coronary Calcification|
- Progression of coronary and valvular calcification confirmed by computed tomography [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Biomarkers for inflammation, measuring of inhibitors of calcification
|Study Start Date:||February 2008|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
patients with required new anticoagulation with phenprocoumon 1/2 of them with a GFR< 60 ml/min and >15 ml/min
patients with required therapy with ASS, 1/2 of them with a GFR <60 ml/min and >15 ml/min
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782743
|Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine|
|Aachen, NRW, Germany, 52074|
|Principal Investigator:||Ralf Koos, MD||RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine|