Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452582
Status:
TERMINATED
Last Update Posted:
2011-03-16
First Post:
2007-03-26
Brief Title:
Sildenafil Viagra Treatment of Subacute Ischemic Stroke
Sponsor:
Henry Ford Health System
Organization:
Henry Ford Health System
Study Overview
Official Title:
Phase 1 Study of Sildenafil Viagra Treatment of Subacute Ischemic Stroke
Status:
TERMINATED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Failure to recruit in expected time period
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Stroke is the third leading cause of death in the United States and the leading cause of serious long-term disability Approximately 50 of the 750000 people affected by stroke each year have residual physical impairment Treatment options for recovery are limited at this time Sildenafil Viagra has demonstrated the capability of significantly improving recovery in several animal experiments of stroke This study is aiming to establish the safety of treatment with sildenafil in people with stroke with the ultimate aim of testing its usefulness to improve recovery
Detailed Description:
Stroke is the third leading cause of death and the leading cause of serious long-term disability in the United States Approximately 15-30 of stroke survivors are permanently disabled Twenty eight percent of stroke patients are under age 65 which results in a loss of work income While many restorative therapies are touted as promising for the treatment of ischemic stroke to date none are approved for this purpose Sildenafil Viagra a phosphodiesterase type 5 inhibitor has been shown to reduce mortality and improve the functional outcomes of young and aged rats when administered 24 hours and 7 days after stroke onset Such results are encouraging and warrant further investigation in human stroke
The specific aims of this study are to assess the safety of treating ischemic stroke patients with sildenafil Viagra and to evaluate their outcomes at day 90 This will be a phase I dose-escalation study with cohort sizes of 12 patients depending on the occurrence of serious adverse events A total enrollment of 120 patients is planned Patients who are between 4 and 7 days from stroke onset will receive 25 50 75 100 125 150 175 and 200 mg daily of sildenafil for a period of 14 days Of the 120 patients 24 will be randomly selected to receive standard treatment but will not receive sildenafil All patients and physicians will be aware of treatment assignment Evaluation of potential toxicity will be monitored throughout the course of treatment and during a formal visit at day 16 after initiation of treatment Plasma monitoring of vascular endothelial growth factor VEGF will be made prior to treatment at days 7 16 30 60 and 90 Measurements of NIHSS scores Rankin scores and Barthel indices will be made at days 30 60 and 90 Patients will also be assessed for color vision changes and sexual function during day 16 and day 90 visits There will be every other day phone calls to patients while on treatment The primary outcome measure will be death recurrent stroke and myocardial infarction during treatment Exploratory analysis will include functional outcomes as measured on the neurological scales and changes in VEGF levels in relation to clinical outcome
The long-term objective is to identify a safe and easily administered treatment that improves functional outcome in patients with ischemic stroke
The specific aims of this study are to assess the safety of treating ischemic stroke patients with sildenafil Viagra and to evaluate their outcomes at day 90 This will be a phase I dose-escalation study with cohort sizes of 12 patients depending on the occurrence of serious adverse events A total enrollment of 120 patients is planned Patients who are between 4 and 7 days from stroke onset will receive 25 50 75 100 125 150 175 and 200 mg daily of sildenafil for a period of 14 days Of the 120 patients 24 will be randomly selected to receive standard treatment but will not receive sildenafil All patients and physicians will be aware of treatment assignment Evaluation of potential toxicity will be monitored throughout the course of treatment and during a formal visit at day 16 after initiation of treatment Plasma monitoring of vascular endothelial growth factor VEGF will be made prior to treatment at days 7 16 30 60 and 90 Measurements of NIHSS scores Rankin scores and Barthel indices will be made at days 30 60 and 90 Patients will also be assessed for color vision changes and sexual function during day 16 and day 90 visits There will be every other day phone calls to patients while on treatment The primary outcome measure will be death recurrent stroke and myocardial infarction during treatment Exploratory analysis will include functional outcomes as measured on the neurological scales and changes in VEGF levels in relation to clinical outcome
The long-term objective is to identify a safe and easily administered treatment that improves functional outcome in patients with ischemic stroke
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