跳至主要内容
临床试验/EUCTR2007-001685-33-DE
EUCTR2007-001685-33-DE进行中(未招募)1 期

Prospective Comparison of Phenpocoumon (Marcumar) and Acetylsalicylic Acid (ASS) as to Progression of the Valvular and Coronary Calcification. - ASS-Marcumar

RWTH Aachen University0 个研究点目标入组 120 人开始时间: 2007年11月13日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
120

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •- 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

排除标准

  • •- 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

研究者

相似试验