Comparison of Phenprocoumon and Acetylsalicylic Acid (ASA)

Completed

• Conditions: Valvular Calcification; Coronary Calcification

• Registration Number: NCT00782743
• Lead Sponsor: RWTH Aachen University

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 Description

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 Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-10-29
• Study First Submitted QC: 2008-10-29
• Study First Posted: 2008-10-31
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression of coronary and valvular calcification confirmed by computed tomography	18 months

Secondary Outcome Measures

Name	Time	Method
Measurement of inhibitors of calcification and biomarkers for inflammation (blood samples), evaluation of the haemodynamic progress as well as dyastolic dysfunction (echocardiography)	18 months

Trial Locations

Locations (1)

Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine; 🇩🇪 Aachen, NRW, Germany