Coronary artery disease
Conditions
Interventions
Trade Name: Nitrolingual-Akut-Spray
Product Name: Nitroglycerin-Akut-Spray
Product Code: COIDA02
Pharmaceutical Form: Oromucosal spray
INN or Proposed INN: Glyceroltrinitrat
CAS Number: 007783-C720
Co
Sponsors
Park-Klinikum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Coronary artery disease, angina and exercise test 50 - 150 watts, patient motivated for rehabilitation, age above 18 years. 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: valvular heart disease, pacemaker, ICD, heart failure NYHA III - IV, LBBB, nitrates, malignant arrhythmias, unstable angina, left ventricular ejection fraction < 40%, digitalis-medication, pregnancy and nursing, child bearing women without contraception, patients with atrial fibrillation, systolic blood-pressure < 100 mmHg, intake of phosphodiesterase-inhibitors, patients with main-stem-stenosis or 2 - 3 vessel disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: better physical endurance documented by ergometry before and after 3-week-rehabilitation period: a placebo versus nitroglycerin study.;Secondary Objective: quality of life questionnairy, symptoms of angina, adverse events and serious adverse events.;Primary end point(s): time to angina threshold and time to ST-depression at ergometry | — |
Countries
Germany
Outcome results
None listed