coronary artery disease with a single coronary vessel requiring stent implantation MedDRA version: 9.1 Level: LLT Classification code 10011089 Term: Coronary artery stenosis
Conditions
Interventions
Trade Name: Ebrantil 25 mg-Ampullen
Pharmaceutical Form: Solution for injection
INN or Proposed INN: urapidil
CAS Number: 64887145
Other descriptive name: URAPIDIL HYDROCHLORIDE
Concentration unit: mg
Sponsors
KA Rudolfstiftung - 2. Medizinische Abteilung
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Austria
Outcome results
None listed