Comparison of Phenprocoumon and Acetylsalicylic Acid (ASA)
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|ClinicalTrials.gov Identifier: NCT00782743|
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : September 23, 2015
|Condition or disease|
|Valvular Calcification Coronary Calcification|
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.
|Study Type :||Observational|
|Actual Enrollment :||157 participants|
|Official Title:||Prospective Comparison of Phenprocoumon (Marcumar) and Acetylsalicylic Acid (ASA)With Regard to the Progress of Valvular and Coronary Calcification|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
patients with required new anticoagulation with phenprocoumon 1/2 of them with a GFR< 60 ml/min and >15 ml/min
patients with required therapy with ASS, 1/2 of them with a GFR <60 ml/min and >15 ml/min
- Progression of coronary and valvular calcification confirmed by computed tomography [ Time Frame: 18 months ]
- 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 ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00782743
|Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine|
|Aachen, NRW, Germany, 52074|
|Principal Investigator:||Vincent Brandenburg, Prof.||RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine|