Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059306
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2003-04-23
Brief Title:
Secondary Prevention of Small Subcortical Strokes Trial
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Secondary Prevention of Small Subcortical Strokes SPS3 Trial
Status:
COMPLETED
Status Verified Date:
2013-04
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:
SPS3
Brief Summary:
The goal of this study is to learn if combination antiplatelet therapy aspirin and clopidogrel is more effective than aspirin alone for the prevention of recurrent stroke and cognitive decline and if intensive blood pressure control is associated with fewer recurrent strokes and cognitive decline
On July 21 2011 the DSMB recommended terminating the anti platelet arm of the study due to an imbalance of overall and major non-CNS hemorrhagic SAEs and total deaths in the investigational anti platelet combination of aspirin clopidogrel and an interim statistical analysis that demonstrated futility in the investigational anti platelet arm It was recommended that patients be continued on standard care of aspirin mono therapy until their study close-out visit Also recommended the continuation and completion of the plood pressure arm following the protocol
On July 21 2011 the DSMB recommended terminating the anti platelet arm of the study due to an imbalance of overall and major non-CNS hemorrhagic SAEs and total deaths in the investigational anti platelet combination of aspirin clopidogrel and an interim statistical analysis that demonstrated futility in the investigational anti platelet arm It was recommended that patients be continued on standard care of aspirin mono therapy until their study close-out visit Also recommended the continuation and completion of the plood pressure arm following the protocol
Detailed Description:
Stroke is damage to the brain caused by problems in the blood vessels Strokes often cause paralysis loss of sensation and speech and other problems A lacunar or small Subcortical stroke affects the inner part of the brain causing small pea sized areas of damage due to blockage of small blood vessels within the brain
This multi-center study will recruit 3000 participants 20 percent of whom will be Hispanic to find out if using aspirin and clopidogrel is more effective than using aspirin alone to prevent recurrent stroke in patients with lacunar stroke confirmed by MRI and if lowering a patients blood pressure below the usual limits will also help prevent recurrent stroke and maintain thinking ability Both aspirin and clopidogrel are widely-used for blood clotting and stroke prevention Investigators intend to find out if using the drugs together is more effective than using aspirin alone
Participants will be randomly assigned to one of 2 types of treatment either aspirin alone or the combination of aspirin and clopidogrel In addition participants will be assigned to one of 2 groups of blood pressure control The difference between the two groups is the target level of systolic blood pressure-either 130-149 or below 130 The goal of the blood pressure aspect of this trial is to find out if lowering blood pressure after stroke helps to prevent recurrent stroke and preserves cognition
This multi-center study will recruit 3000 participants 20 percent of whom will be Hispanic to find out if using aspirin and clopidogrel is more effective than using aspirin alone to prevent recurrent stroke in patients with lacunar stroke confirmed by MRI and if lowering a patients blood pressure below the usual limits will also help prevent recurrent stroke and maintain thinking ability Both aspirin and clopidogrel are widely-used for blood clotting and stroke prevention Investigators intend to find out if using the drugs together is more effective than using aspirin alone
Participants will be randomly assigned to one of 2 types of treatment either aspirin alone or the combination of aspirin and clopidogrel In addition participants will be assigned to one of 2 groups of blood pressure control The difference between the two groups is the target level of systolic blood pressure-either 130-149 or below 130 The goal of the blood pressure aspect of this trial is to find out if lowering blood pressure after stroke helps to prevent recurrent stroke and preserves cognition
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CRC | None | None | None |