Patients with coronary artery disease who suffer from myocardial malperfusion and continue to experience angina despite maximal medical and revascularization therapy are called "no-option" patients.
Conditions
Interventions
Trade Name: Revatio
Product Name: Revatio
Product Code: G04BE03
Pharmaceutical Form: Tablet
INN or Proposed INN: Sildenafil
CAS Number: 171599-83-0
Other descriptive name: SILDENAFIL CITRATE
Concentra
Sponsors
Medizinische Universität Wien, Klinik für Innere Medizin II, Abteilung für Kardiologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Stable angina pectoris 2) Evidence for myocardial ischemia according to the presence of one or more of the followings: - Typical angina during exercise test or - Significant reversible perfusion defects on dipyridamole myocardial radionuclide study 3) Coronary artery disease of at least one large epicardial coronary artery with =70% stenosis remaining from which new collaterals/vessels could be supplied 4) Coronary artery disease judged to be unsuitable for surgical or percutaneous revascularisation due to extensive atherosclerosis 5) Optimized anti-ischemic drug therapy (including beta-blocker therapy with at least 50% target dose) 6) Subject must be willing and able to give informed consent Eligible patients must fulfil all 6 inclusion criteria. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1) STEMI or NSTEMI within the past 3 months 2) Revascularisation procedures within the last 3 months 3) Severely reduced systolic left ventricular function EF 2.5mg/dl 6) Diabetes mellitus with proliferative retinopathy 7) Diagnosed or suspected cancer 8) Chronic inflammatory disease 9) Therapy with nitrates and nicorandil 10) Women who are pregnant or lactating 11) Patients with a total occluded vessel and reversible perfusion defects at the marginal zone of scare tissue if they have no additional stenosed vessels causing significant reversible perfusion defects. 12) Patients with a total occluded vessel and perfusion defect at rest despite evidence of vital myocardium, if they have no additional stenosed vessels causing significant reversible perfusion defects. Eligible patients must demonstrate none of the exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to prospectively investigate if intermittent Phosphodiesterase 5 inhibition for 15 weeks improves myocardial perfusion by angiogenesis in patients with therapy refractory myocardial ischemia due to coronary artery disease judged to be unsuitable for surgical or percutaneous revascularisation.;Secondary Objective: The aim of this study is to prospectively investigate if intermittent Phosphodiesterase 5 inhibition for 15 weeks improves myocardial perfusion by angiogenesis in patients with therapy refractory myocardial ischemia due to coronary artery disease judged to be unsuitable for surgical or percutaneous revascularisation.;Primary end point(s): Primary Endpoint: - Total exercise duration (bicycle exercise testing) ;Timepoint(s) of evaluation of this end point: baseline after 12 weeks of treatment 4 weeks after end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints: - Time to 1mm ST-segment depression (bicycle exercise testing) - Time to limiting angina (bicycle exercise testing) - Myocardial blood flow (PET) - Left ventricular ejection fraction (PET) - Mean angina frequency per week - Score Seattle Angina Questionnaire - Natriuretic peptides - Markers of angiogenesis ;Timepoint(s) of evaluation of this end point: baseline after 12 weeks of treatment 4 weeks after end of treatment | — |
Countries
Austria
Contacts
Public ContactRudolf Berger
Medizinische Universität Wien
Outcome results
None listed