Treatment with oral anti-coagulants prevents thromboembolic complications e.g at atrial fibrillation or artificial heart valves. Primary objective of the study is the prospective comparison of the coronary and valvular Calcification on patients with newly induced long-term tehrapy with Phenprocoumon versus a patient colletive with ASS-therapy of the same age.
Conditions
Interventions
Trade Name: Marcumar®
Pharmaceutical Form: Tablet
Trade Name: Aspirin® protect 100 mg
Pharmaceutical Form: Tablet
Sponsors
RWTH Aachen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Caucasian from 50 to 90 years - BMI from 19 to 27 kg/m² - (1) Patients with newly induced antcoagulation with Phenprocoumon, planned for at least 1 year. The most frequent indication for a Phenprocoumon thearpy are atrial fibrillation, heart valve replacement, and a strongly restricted LV function - or (2) control collective with the standard ASS therapy (100mg/d). The most frequent indication for this therapy is the coronary artery disease - persons, who are sui juris and mentally able to understand and follow the instructions of the study staff - signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: - renal insuffiency stage IV or V - acute cardiac or pulmonary decompensation - increased serum level of calcium - women of childbearing age or present pregenancy or lactation - psychiatric disease - individuals, who are accomodated in an instution on juridicial or official order - life expectancy <1 year - acute life-threatening condition of the patient - Individuals, who have a relationship of dependency to or work for the sponsor or the investigator - simultaneous participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is the comparison of coronary and valvular progression of calcification in the multi-slice CT at patients with Phenprocoumon therapy versus patients with ASS therapy. Therefore the main objective is the change of the coronary and valvular calcification score determined in CT in both groups after 18 months in comparison to the initial value. ;Secondary Objective: Important secondary objectives are the serum levels of calcification inhibitors (MGP, Fetuin, and OPG) and other markers of inflammation (hsCRP). These are correlated with the hemodynamic progression of a heart valve vitium and the progression of calcification. Furthermore, the valvular hemodynamic progression in echocardiography is compared in patients with Phenprocoumon therapy and patients with ASS therapy. Also, a comparison of the diastolic dysfunction in echocardiography in patients with Phenprocoumon and ASS therapy is done. In addition, the initial valvular and coronary calcification score schould be evaluated as predictor for subsequent cardial events as death, myocardial infarct or heart valve replacement. Morover a correlation of the progression of the calcification with the echocardiographic determined increase of a heart valve vitium is planned. ;Primary end point(s): Comparison;Timepoint(s) of evaluation of this end point: After last visit of last patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - comparison of serum levels of calcification inhibitors (MGP; Fetuin, OPG) and other markers of inflammation of both arms - correlation of these with the hemodynamc progression of heart valve vitium and the progression of calcification - comparison of the valvular hemodynamic progression in echocardigraphy in patients with phenprocoumon therapy versus patients with ASS therapy. - comparison of diastolic dysfunction in echocardiography in patients with phenprocoumon therapy versusu patients with ASS therapy - evaluation of the initial valvular and coronary calcification score as a predictor for subsequent cardiac events as death, myocardial infarct or artificial heart valves - correlation of the progression of the calcification with the increase of a heart valve vitium assigned with echocardiography;Timepoint(s) of evaluation of this end point: After last visit of last patient | — |
Countries
Germany
Contacts
Public ContactStudienzentrum
CTC-A
Outcome results
None listed