Comparison of Phenprocoumon and Acetylsalicylic Acid (ASA)

RWTH Aachen University157 enrolled

Overview

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

Patients will be allocated to two groups with either 1. anticoagulation with phenprocoumon (needed for at least 1 year) 2. 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.

Study Type

OBSERVATIONAL

Enrollment

157

Conditions

Valvular Calcification Coronary Calcification

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine

Aachen, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

Progression of coronary and valvular calcification confirmed by computed tomography

Time frame: 18 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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