Status:
WITHDRAWN
Therapeutic Effect of Sildenafil in Patients With Coronary Vasospasm
Lead Sponsor:
Udo Sechtem
Conditions:
Coronary Vasospasm
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief 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. ...
Detailed Description
Coronary artery spasm is an abrupt severe vasoconstrictor response which may occur spontaneously in normal and diseased coronary arteries. It may result in myocardial ischemia and may be provoked by v...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00454714
Start Date
March 1 2007
End Date
December 31 2009
Last Update
April 12 2017
Active Locations (1)
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1
Robert-Bosch-Krankenhaus
Stuttgart, Germany, 70376