Therapeutic Effect of Sildenafil in Patients With Coronary Vasospasm

• Status: Withdrawn
• Trial end date: 2009-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This will be a prospective, phase IIIb, double-blind and randomized trial testing the effect of single dose sildenafil application in patients with coronary vasospasm compared to placebo application.

The target variable to be tested is the degree of coronary vasoconstriction in response to intracoronary ACh application (in addition to clinical chest pain) which will be imaged by coronary angiography and measured using quantitative coronary angiography software.

Main objective: Has sildenafil the potency to inhibit the induction of coronary vasospasm by intracoronary ACh-application in patients with proven coronary artery spasm?

Secondary objective: Which degree of coronary vasospasm inhibition can be achieved with sildenafil?

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Udo Sechtem
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• age ≥ 50y

• Framingham risk score < 10%

• no contraindication to sildenafil application

• clinical history of atypical angina pectoris

• exclusion of significant coronary artery disease (stenosis ≥ 50%) by coronary angiography

• documented coronary spasm by ACh-testing in at least one coronary artery segment

• written informed consent

Exclusion Criteria:

• existing contraindication to sildenafil application

• significant coronary artery disease (≥ 50%)

• valvular, inflammatory, dilative or other cardiomyopathies

• congestive heart failure (left ventricular ejection fraction < 60%) of any reason

• need for therapeutic treatment with nitrates or intake of any nitrates in the last 24h before coronary angiography

• participation in another clinical trial at the moment or in the last 30 days

• hypotonic blood pressure (<90/50mmHg)

• hepatic insufficiency (> Child-Pugh-classification A)

• renal insufficiency with a GFR < 60ml/min- pregnancy or lactation

• not able to consent