Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454714
Status:
WITHDRAWN
Last Update Posted:
2017-04-12
First Post:
2007-03-29
Brief Title:
Therapeutic Effect of Sildenafil in Patients With Coronary Vasospasm
Sponsor:
Udo Sechtem
Organization:
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Study Overview
Official Title:
Application of Sildenafil in Patients With Documented Coronary Vasospasm to Explore the Pathophysiology of Coronary Vasospasm and the Therapeutic Effect of Sildenafil in Patients Suffering From Coronary Vasospasm
Status:
WITHDRAWN
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study not started
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 various stimuli such as acetylcholine ACh Coronary vasospasm is involved in the pathogenesis of Prinzmetals angina acute myocardial infarction or sudden cardiac death due to ventricular arrythmias and chest pain symptoms associated with viral myocarditis
The precise cellular and molecular mechanisms of coronary vasospasm have not yet been elucidated The most often suggested but competing explanations for this disease are coronary endothelial dysfunction secondary to impaired nitric oxide production versus coronary smooth muscle cell hyperreactivity with or without additional endothelial dysfunction As the precise cellular mechanism is currently unknown a large group of people can currently not be treated appropriately despite the use of nitrates and calcium antagonists
Sildenafil is a phosphodiesterasePDE-5 inhibitor approved for the treatment of both erectile dysfunction and pulmonary hypertension PDE-5 has been shown to be also present and play an important vasomotor role in the coronary vessel wall Application of the inhibitor sildenafil has been shown to increase the resting coronary artery diameter Furthermore atherosclerotic coronary artery segments which vasoconstrict following intracoronary ACh-application vasodilate following the application of sildenafil when ACh-testing is repeated Other studies are also suggesting an improved endothelial function after sildenafil application for both the coronary and the peripheral vasculature
Taken together sildenafil is expected to have a positive effect on coronary vasomotility Whether sildenafil can totally prevent the occurrence of coronary vasospasm or at least decrease the severity of vasospasm has not been studied so far Thus the aim of this study is to analyse the possible anti-spastic effects of sildenafil in patients suffering from coronary vasospasm
The precise cellular and molecular mechanisms of coronary vasospasm have not yet been elucidated The most often suggested but competing explanations for this disease are coronary endothelial dysfunction secondary to impaired nitric oxide production versus coronary smooth muscle cell hyperreactivity with or without additional endothelial dysfunction As the precise cellular mechanism is currently unknown a large group of people can currently not be treated appropriately despite the use of nitrates and calcium antagonists
Sildenafil is a phosphodiesterasePDE-5 inhibitor approved for the treatment of both erectile dysfunction and pulmonary hypertension PDE-5 has been shown to be also present and play an important vasomotor role in the coronary vessel wall Application of the inhibitor sildenafil has been shown to increase the resting coronary artery diameter Furthermore atherosclerotic coronary artery segments which vasoconstrict following intracoronary ACh-application vasodilate following the application of sildenafil when ACh-testing is repeated Other studies are also suggesting an improved endothelial function after sildenafil application for both the coronary and the peripheral vasculature
Taken together sildenafil is expected to have a positive effect on coronary vasomotility Whether sildenafil can totally prevent the occurrence of coronary vasospasm or at least decrease the severity of vasospasm has not been studied so far Thus the aim of this study is to analyse the possible anti-spastic effects of sildenafil in patients suffering from coronary vasospasm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None