Comparison of Phenprocoumon and Acetylsalicylic Acid (ASA)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00782743

Enrollment

157

Registered

2008-10-31

Start date

2008-02-29

Completion date

2015-08-31

Last updated

2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Calcification, Valvular Calcification

Keywords

phenprocoumon, anticoagulation, acetylic salicylic acid, Need for new anticoagulation treatment

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progression of coronary and valvular calcification confirmed by computed tomography	18 months

Secondary

Measure	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

Countries

Germany

Outcome results