/A
- Conditions
- coronary artery disease with a single coronary vessel requiring stent implantationMedDRA version: 9.1Level: LLTClassification code 10011089Term: Coronary artery stenosis
- Registration Number
- EUCTR2007-003026-14-AT
- Lead Sponsor
- KA Rudolfstiftung - 2. Medizinische Abteilung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
- coronary artery disease with a single coronary vessel requiring intervention
- patients of both sexes between 18 and 80 years of age
- stable angina pectoris
- regular sinus rhythm in electrocardiogram
- body weight = 55 kg and = 100 kg
- written 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- contraindication for the IMP
- coronary artery disease with more than one coronary vessels requiring intervention
- acute coronary syndrome defined as unstable angina pectoris, ST elevation
myocardial infarction (STEMI), and non-ST elevation myocardial infarction (STEMI)
- concomitant treatment with the following glycoprotein (GP) IIb/IIIa inhibitors:
Abciximab (ReoPro®), Ebtafibatid (Integrilin®), or Tirofiban (Agrastat®)
- pacemaker patient or patient with implanted cardiac defibrillator
- severe aortic stenosis and/or aortic insufficiency, severe mitral stenosis and/or
insufficiency
- serum creatinin > 1.5 mg/dl
- hypotonia (SBP = 100 mmHg measured in lying position)
- at least one of the following events within 3 months prior to enrolment date:
myocardial infarction, transient ischemic attack (TIA), prolonged ischemic neurological
deficit (PRIND), stroke
- cardiac ejection fraction < 35%
- NYHA class 3 or higher
- concomitant treatment with alpha receptor blocking agents within 6 months
prior to enrolment date
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: investigation of the effects of urapidil treatment on the therapeutic effects of PTCA and stent implantation;Secondary Objective: safety and tolerbility of urapidil;Primary end point(s): Primary variable is the cardiac ejection fraction as measured by trans-thoracic echocardiography (TTE) 180 days after stenting
- Secondary Outcome Measures
Name Time Method