Clinical trial NCT00782743: Comparison of Phenprocoumon and Acetylsalicylic Acid (ASA)
Official title: Prospective Comparison of Phenprocoumon (Marcumar) and Acetylsalicylic Acid (ASA)With Regard to the Progress of Valvular and Coronary Calcification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Valvular Calcification
Coronary Calcification
Keywords: phenprocoumon
anticoagulation
acetylic salicylic acid
Need for new anticoagulation treatment
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2008-10-31
Enrollment: 157
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with required therapy with either ASS or phenprocoumon

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression of coronary and valvular calcification confirmed by computed tomography
timeFrame: 18 months
Secondary outcomes:
measure: Measurement of inhibitors of calcification and biomarkers for inflammation (blood samples), evaluation of the haemodynamic progress as well as dyastolic dysfunction (echocardiography)
timeFrame: 18 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
state: NRW
Study officials:
affiliation: RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
name: Vincent Brandenburg, Prof.
role: PRINCIPAL_INVESTIGATOR
References: