Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026039
Status:
COMPLETED
Last Update Posted:
2006-05-15
First Post:
2001-11-07
Brief Title:
Womens Estrogen for Stroke Trial WEST
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institute of Neurological Disorders and Stroke NINDS
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine if estrogen hormone replacement therapy reduces the risk of stroke or death in postmenopausal women who have already had stroke or a transient ischemic attack TIA
Detailed Description:
The researchers enrolled 664 postmenopausal women with an average age of 71 years who had experienced an ischemic stroke or a TIA within the previous 90 days Ischemic strokes and TIAs result from blockages in the vessels that supply blood to the brain Participants were given a number of initial assessments including the NIH Stroke Scale NIHSS of neurological impairment and the Barthel index of functional ability in activities of daily living In addition to the usual best care for patients who have had a stroke women in the trial received either oral estrogen estradiol 17-beta at the standard replacement dose of 1 mg daily or a matching placebo Patients were studied for an average of 28 years They stopped receiving the estrogen or placebo if they had a stroke
The researchers found that there was no significant difference in the incidence of stroke or death in the women who were randomly assigned to receive estrogen instead of placebo However they found that the incidence of death due to stroke was higher in the estrogen group and that the non-fatal strokes in that group were associated with slightly worse neurological and functional impairments at 1 month after stroke The risk of stroke within the first 6 months after enrollment in the study was also higher among women in the estrogen group There were no significant differences between treatment groups in the number of TIAs or non-fatal heart attacks However participants receiving estrogen were more likely to experience gynecologic complications particularly vaginal bleeding
The researchers found that there was no significant difference in the incidence of stroke or death in the women who were randomly assigned to receive estrogen instead of placebo However they found that the incidence of death due to stroke was higher in the estrogen group and that the non-fatal strokes in that group were associated with slightly worse neurological and functional impairments at 1 month after stroke The risk of stroke within the first 6 months after enrollment in the study was also higher among women in the estrogen group There were no significant differences between treatment groups in the number of TIAs or non-fatal heart attacks However participants receiving estrogen were more likely to experience gynecologic complications particularly vaginal bleeding
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: