Comparison of Phenprocoumon and Acetylsalicylic Acid (ASA)

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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Prospective Comparison of Phenprocoumon (Marcumar) and Acetylsalicylic Acid (ASA)With Regard to the Progress of Valvular and Coronary Calcification

Conditions
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Valvular Calcification, Coronary Calcification

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 60 patients with new onset of anticoagulation therapy with phenprocoumon for the expectant duration of at least one year BMI 19-27 kg/qm Mental ability and capacity to understand and follow the instructions of the investigator Written informed consent Exclusion Criteria: Patients not fulfilling the inclusion criteria or with: renal failure grade IV or V acute cardial or pulmonary decompensation women of childbearing age, pregnant or breastfeeding women psychiatric diseases life expectancy < 1 year acute lifethreatening situations participation in other studies persons in dependency from the sponsor or working with the sponsor

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>patients with required new anticoagulation with phenprocoumon 1/2 of them with a GFR< 60 ml/min and >15 ml/min | |
| 2<br>patients with required therapy with ASS, 1/2 of them with a GFR <60 ml/min and >15 ml/min | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of coronary and valvular calcification confirmed by computed tomography |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of inhibitors of calcification and biomarkers for inflammation (blood samples), evaluation of the haemodynamic progress as well as dyastolic dysfunction (echocardiography) |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phenprocoumon, anticoagulation, acetylic salicylic acid, Need for new anticoagulation treatment