Prospective Comparison of Phenprocoumon (Marcumar) and Acetylsalicylic Acid (ASA)With Regard to the Progress of Valvular and Coronary Calcification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Progression of coronary and valvular calcification confirmed by computed tomography
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Progression of coronary and valvular calcification confirmed by computed tomography
时间窗: 18 months
次要结局
- Measurement of inhibitors of calcification and biomarkers for inflammation (blood samples), evaluation of the haemodynamic progress as well as dyastolic dysfunction (echocardiography)(18 months)