Therapeutic Effect of Sildenafil in Patients With Coronary Vasospasm

NCT00454714 | Withdrawn Phase 3

• 1 other identifier: RBK091
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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?

Conditions

Coronary Vasospasm

Outcome Measures

Primary Outcomes (1)

• Incidence of coronary vasospasm in spite of medical treatment

  After inclusion of last patient

Study Arms (2)

A

ACTIVE COMPARATOR

Sildenafil arm

Drug: single dose Sildenafil

B

PLACEBO COMPARATOR

Placebo arm

Drug: Single dose placebo

Interventions

single dose Sildenafil DRUG

Application of a single dose Sildenafil

A

Single dose placebo DRUG

Application of a single dose placebo

B

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 50y
• Framingham risk score \< 10%
• no contraindication to sildenafil application
• clinical history of atypical angina pectoris
• documented coronary spasm by ACh-testing in at least one coronary artery segment
• written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Udo Sechtem: lead

Study Sites (1)

Robert-Bosch-Krankenhaus

Stuttgart, 70376, Germany

Location

MeSH Terms

Conditions

Coronary Vasospasm

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Udo Sechtem, MD

  Robert Bosch-Krankenhaus Stuttgart

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Udo Sechtem

Study Record Dates

• First Submitted: March 29, 2007
• First Posted: April 2, 2007
• Study Start: March 1, 2007
• Primary Completion: December 31, 2009
• Study Completion: December 31, 2009
• Last Updated: April 12, 2017

Record last verified: 2017-04

Locations

DE (1)