Safety Study of Sildenafil in Treatment of Cerebral Aneurysm Vasospasm

NCT00871065 | Withdrawn Phase 2 DMC

• 1 other identifier: 0165-08-FB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Rupture of a cerebral aneurysm is a serious medical condition that may result in permanent disability or even death just related to the aneurysm rupture itself. Patients who undergo successful surgical treatment of their aneurysm will rarely experience problems related to that specific aneurysm in the future. However, blood that is on the surface of the brain from the initial aneurysm rupture is very irritating to other blood vessels that it comes in contact with. When these blood vessels become irritated, they spasm and become narrower. This narrowing restricts blood flow through the vessel, and if severe can result in a stroke that is caused by inadequate blood flow through the vessel. Depending on location and severity, this condition of vessel spasm (cerebral vasospasm) may result in permanent disability or death. Treatment to prevent cerebral vasospasm decreases the risk of stroke. This research is trying to see if a medication that is FDA approved for the treatment of lung disease and sexual dysfunction can be used to prevent and/or treat cerebral vasospasm.

Conditions

Cerebral Vasospasm; Subarachnoid Hemorrhage

Keywords

Cerebral Vasospasm; Vasospasm; Subarachnoid Hemorrhage; Sildenafil citrate; Aneurysm; Intracranial aneurysm

Outcome Measures

Primary Outcomes (1)

• Onset of cerebral vasospasm

  Onset of cerebral vasospasm, defined as transcranial Doppler velocity exceeding 120 cm/sec.

  Daily measurements for 12 days

Secondary Outcomes (2)

• Long-term participant functional outcome

  6 months

• Long-term participant activities of daily living outc

  6 months

Study Arms (1)

Sildenafil Treatment of Cerebral Aneurysm Vasospasm

EXPERIMENTAL

Trial Arm (single arm study)

Drug: Sildenafil citrate

Interventions

Sildenafil citrate DRUG

20 mg tablet orally every 8 hours until Day 14 post-hemorrhage

Also known as: Viagra, Revatio

Sildenafil Treatment of Cerebral Aneurysm Vasospasm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subarachnoid Hemorrhage (Fisher Grade 3)
• Cerebral Aneurysm documented by computed tomography angiography (CTA)/magnetic resonance angiography (MRA)/Cerebral Angiogram
• Enrollment within 48 hours of symptom onset

You may not qualify if:

• Hypersensitivity to Sildenafil
• Pregnancy
• Age less than 19 years
• Concurrent use of nitrates or alpha-blockers
• Aneurysm related to an arteriovenous malformation
• Delayed enrollment past 48 hours
• Subarachnoid hemorrhage that is not Fisher Grade 3

Sponsors & Collaborators

• University of Nebraska: lead

MeSH Terms

Conditions

Vasospasm, Intracranial; Subarachnoid Hemorrhage; Aneurysm; Intracranial Aneurysm

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Arterial 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

• William E Thorell, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

• Guy A Music, MD

  University of Nebraska

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 30, 2009
• Study Start: July 1, 2008
• Primary Completion: February 25, 2009
• Study Completion: February 25, 2009
• Last Updated: August 15, 2023

Record last verified: 2023-08