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Completed

NCT Number: NCT00782743

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

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Key information

Conditions

Valvular Calcification Coronary Calcification

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Progression of coronary and valvular calcification confirmed by computed tomography

    Time frame: 18 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Oct 31, 2008
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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