Application of Sildenafil in patients with documented coronary vasospasm in order to explore the pathophysiology of coronary vasospasm and the therapeutic effects of Sildenafil in patients suffering from coronary spasm

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2006
INTERVENTION: 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‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: 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. PRIMARY OUTCOME: Main Objective: Has Sildenafil the potency to inhibit the induction of coronary vasospasm? Primary end point(s): Inhibition of coronary spasm induction with the use of intracoronary acetylcholine after taking Sildenafil Secondary Objective: Which degree of spasm inhibition can be achieved with Sildenafil? 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
Epistemonikos ID: d3b0ab9bfe2b694a0f24cdbafae5f62675e4e465
First added on: Jul 27, 2021