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Therapeutic Effect of Sildenafil in Patients With Coronary Vasospasm
This study is currently recruiting participants.
Verified by Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK), May 2008
First Received: March 29, 2007   Last Updated: May 29, 2008   History of Changes
Sponsored by: Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK)
Information provided by: Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK)
ClinicalTrials.gov Identifier: NCT00454714
  Purpose

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?


Condition Intervention Phase
Coronary Vasospasm
Drug: single dose Sildenafil
Drug: Single dose placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK):

Primary Outcome Measures:
  • Incidence of coronary vasospasm in spite of medical treatment [ Time Frame: After inclusion of last patient ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: March 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator
Sildenafil arm
Drug: single dose Sildenafil
Application of a single dose Sildenafil
B: Placebo Comparator
Placebo arm
Drug: Single dose placebo
Application of a single dose placebo

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 Prinzmetal's 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 phosphodiesterase(PDE)-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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454714

Locations
Germany
Robert-Bosch-Krankenhaus Recruiting
Stuttgart, Germany, 70376
Contact: Ali Yilmaz, MD     49-711-8101 ext 5587     ali.yilmaz@rbk.de    
Sponsors and Collaborators
Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK)
Investigators
Study Director: Udo Sechtem, MD Robert-Bosch-Krankenhaus Stuttgart
  More Information

No publications provided

Responsible Party: Division of Cardiology ( Robert Bosch Hospital )
Study ID Numbers: RBK091
Study First Received: March 29, 2007
Last Updated: May 29, 2008
ClinicalTrials.gov Identifier: NCT00454714     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:
Coronary Disease
Vasodilator Agents
Phosphodiesterase Inhibitors
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Coronary Vasospasm
Sildenafil
Cardiovascular Agents
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Vasodilator Agents
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Vascular Diseases
Coronary Vasospasm
Sildenafil
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Coronary Disease
Phosphodiesterase Inhibitors
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 02, 2009