Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000527
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
1999-10-27
Brief Title:
Recurrent Carotid Stenosis
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-12
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 whether recurrent stenosis following carotid endarterectomy could be reduced by pre- and post-operative oral administration of platelet-inhibiting drugs
Detailed Description:
BACKGROUND
Following endarterectomy platelets adhere and aggregate on the endarterectomized surface and release platelet-derived growth factor which induces smooth muscle cell migration and proliferation which may result in restenosis Many patients had been treated with aspirin and dipyridamole but not in a controlled trial The Recurrent Carotid Stenosis Study established whether antiplatelet therapy was beneficial in the prevention of recurrent carotid artery stenosis
DESIGN NARRATIVE
Randomized double-blind Eighty-three patients 90 endarterectomies were randomly assigned to receive 325 mg of oral aspirin plus 75 mg of dipyridamole beginning 12 hours pre-operatively followed by a second dose administered within eight hours after the operation and given three times daily thereafter for one year Eighty patients 85 endarterectomies received placebo After the adequacy of the surgical procedure was confirmed by intraoperative angiography restenosis at the endarterectomy sites was evaluated using serial duplex ultrasound before hospital discharge and at three-month intervals postoperatively for one year
Following endarterectomy platelets adhere and aggregate on the endarterectomized surface and release platelet-derived growth factor which induces smooth muscle cell migration and proliferation which may result in restenosis Many patients had been treated with aspirin and dipyridamole but not in a controlled trial The Recurrent Carotid Stenosis Study established whether antiplatelet therapy was beneficial in the prevention of recurrent carotid artery stenosis
DESIGN NARRATIVE
Randomized double-blind Eighty-three patients 90 endarterectomies were randomly assigned to receive 325 mg of oral aspirin plus 75 mg of dipyridamole beginning 12 hours pre-operatively followed by a second dose administered within eight hours after the operation and given three times daily thereafter for one year Eighty patients 85 endarterectomies received placebo After the adequacy of the surgical procedure was confirmed by intraoperative angiography restenosis at the endarterectomy sites was evaluated using serial duplex ultrasound before hospital discharge and at three-month intervals postoperatively for one year
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R37HL041619 | NIH | None | httpsreporternihgovquickSearchR37HL041619 |