Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109382
Status:
COMPLETED
Last Update Posted:
2008-04-08
First Post:
2005-04-27
Brief Title:
Fast Assessment of Stroke and Transient Ischemic Attack to Prevent Early Recurrence FASTER
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Fast Assessment of Stroke and Transient Ischemic Attack to Prevent Early Recurrence FASTER
Status:
COMPLETED
Status Verified Date:
2007-06
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:
Current management of patients with TIA transient ischemic attack or minor stroke includes the prompt investigation and treatment in the days and weeks after the event However new evidence shows patients are at the highest risk of stroke in the first few days after the TIA with 50 of strokes which happen in the three months following TIA occurring within 48-72 hours To date there is no evidence to guide physicians on how to safely reduce this risk
The FASTER trial is focusing on the initial period of high risk starting patients on stroke prevention treatments in the hours following a TIA or minor stroke The drugs to be tested have been shown to be effective in the similar setting of cardiology reducing recurrent cardiac events in patients with unstable angina when commenced with the same speed after an event
All patients will be on aspirin The trial will see if adding another drug clopidogrel has an additional benefit in reducing the number of strokes after TIA or minor stroke within three months of TIA or minor stroke It will also look if the very early introduction of simvastatin a cholesterol lowering therapy reduces stroke after TIA or minor stroke both by itself and in addition to clopidogrel The final aim of the trial is to ensure that these treatments are safe to be used in this population of patients
The FASTER trial is focusing on the initial period of high risk starting patients on stroke prevention treatments in the hours following a TIA or minor stroke The drugs to be tested have been shown to be effective in the similar setting of cardiology reducing recurrent cardiac events in patients with unstable angina when commenced with the same speed after an event
All patients will be on aspirin The trial will see if adding another drug clopidogrel has an additional benefit in reducing the number of strokes after TIA or minor stroke within three months of TIA or minor stroke It will also look if the very early introduction of simvastatin a cholesterol lowering therapy reduces stroke after TIA or minor stroke both by itself and in addition to clopidogrel The final aim of the trial is to ensure that these treatments are safe to be used in this population of patients
Detailed Description:
The Fast Assessment of Stroke and Transient ischemic attack to prevent Early Recurrence FASTER is a randomized clinical trial designed to investigate the effect of hyper-acute initiation of stroke prevention treatments in patients with a minor stroke or transient ischemic attack TIA
This group of individuals has been recognized as being at high risk of recurrent events Johnston et al 2000 were the first to suggest that the risk of stroke after TIA was front-loaded in the first few days This has been confirmed elsewhere with Lovett et al 2003 having shown in the Oxfordshire Community Stroke Project that the 7-day risk of recurrent stroke was 86 and a 30-day risk of 120 These findings are similarly found in the Oxford Vascular Study 80 and 115 respectively for a recurrent event Coull et al 2004 The NASCET North American Symptomatic Carotid Endarterectomy Trial study also supports the finding of high risk of early recurrent stroke 85 of patients with a hemispheric TIA suffered a recurrent stroke within one week rising to 20 at 90-days Eliasziw et al 2004 This data suggest that patients with carotid stenosis are at the highest risk of early recurrent stoke
Only one in four patients with acute ischemic stroke presenting within three hours of symptom onset are being treated with t-PA Barber et al 2001 The most common reason for exclusion from treatment is that a patients deficit will be too mild for treatment or will have completely resolved thereby not meriting the risks of treatment with tPA These are the patients that have a higher risk of early recurrence The clinical imperative is to identify hyper-acute treatment strategies to minimize that risk
FASTER is a double blind randomized controlled trial with a 2x2 factorial design with patients followed for 90-days Patients will be randomized within 24 hours of symptom onset to one of four possible treatment arms
Aspirin
Aspirin and Clopidogrel
Aspirin and Simvastatin
Aspirin and Clopidogrel and Simvastatin
Study Hypotheses
A A rapid commencement of clopidogrel plus aspirin within 24 hours of acute TIA or minor stroke is more effective than aspirin in reducing the 90-day risk of stroke by an absolute difference of 2
B A rapid commencement of simvastatin plus aspirin within 24 hours of acute TIA or minor stroke is more effective than aspirin in reducing the 90-day risk of stroke by an absolute difference of 2
C A rapid commencement of clopidogrel plus aspirin plus simvastatin within 24 hours of acute TIA or minor stroke is more effective than aspirin alone in reducing the 90-day risk of stroke by an absolute difference of 4
D The incidence of adverse events is not different among treatment groups
This group of individuals has been recognized as being at high risk of recurrent events Johnston et al 2000 were the first to suggest that the risk of stroke after TIA was front-loaded in the first few days This has been confirmed elsewhere with Lovett et al 2003 having shown in the Oxfordshire Community Stroke Project that the 7-day risk of recurrent stroke was 86 and a 30-day risk of 120 These findings are similarly found in the Oxford Vascular Study 80 and 115 respectively for a recurrent event Coull et al 2004 The NASCET North American Symptomatic Carotid Endarterectomy Trial study also supports the finding of high risk of early recurrent stroke 85 of patients with a hemispheric TIA suffered a recurrent stroke within one week rising to 20 at 90-days Eliasziw et al 2004 This data suggest that patients with carotid stenosis are at the highest risk of early recurrent stoke
Only one in four patients with acute ischemic stroke presenting within three hours of symptom onset are being treated with t-PA Barber et al 2001 The most common reason for exclusion from treatment is that a patients deficit will be too mild for treatment or will have completely resolved thereby not meriting the risks of treatment with tPA These are the patients that have a higher risk of early recurrence The clinical imperative is to identify hyper-acute treatment strategies to minimize that risk
FASTER is a double blind randomized controlled trial with a 2x2 factorial design with patients followed for 90-days Patients will be randomized within 24 hours of symptom onset to one of four possible treatment arms
Aspirin
Aspirin and Clopidogrel
Aspirin and Simvastatin
Aspirin and Clopidogrel and Simvastatin
Study Hypotheses
A A rapid commencement of clopidogrel plus aspirin within 24 hours of acute TIA or minor stroke is more effective than aspirin in reducing the 90-day risk of stroke by an absolute difference of 2
B A rapid commencement of simvastatin plus aspirin within 24 hours of acute TIA or minor stroke is more effective than aspirin in reducing the 90-day risk of stroke by an absolute difference of 2
C A rapid commencement of clopidogrel plus aspirin plus simvastatin within 24 hours of acute TIA or minor stroke is more effective than aspirin alone in reducing the 90-day risk of stroke by an absolute difference of 4
D The incidence of adverse events is not different among treatment groups
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