Comparison of Marcumar and ASS as to Progression of Heart Valve Calcificatio
- Conditions
- 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.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2007-001685-33-DE
- Lead Sponsor
- RWTH Aachen University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method