Coronary vasospasm is an abrupt severe vasoconstriction of coronary arteries leading to myocardial ischemia and angina pectoris. The reason for the occurrence of coronary spasm and the cellular mechanism causing coronary spasm is still not elucidated. Thus, an appropriate medical therapy has not been established so far. In patients suffering from coronary vasospasm the possible anti-spastic effect of sildenafil is to be analysed with this study.
Conditions
Interventions
Trade Name: Viagra
Pharmaceutical Form: Tablet
INN or Proposed INN: Sildenafil
CAS Number: 171599-83-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceu
Sponsors
Prof. Sechtem, Department of Cardiology, Robert Bosch Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - agreement with this study - documentation of coronary vasospasm in a diagnostic intracoronary acetylcholine-testing 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 against Sildenafil - presence of coronary artery disease - cardiomyopathy - hepatic diseases - age < 50y
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Has Sildenafil the potency to inhibit the induction of coronary vasospasm?;Secondary Objective: Which degree of spasm inhibition can be achieved with Sildenafil?;Primary end point(s): Inhibition of coronary spasm induction with the use of intracoronary acetylcholine after taking Sildenafil | — |
Countries
Germany
Outcome results
None listed