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Recurrent Carotid Stenosis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000527
Enrollment
Unknown
Registered
1999-10-28
Start date
1986-08-31
Completion date
1998-11-30
Last updated
2013-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Carotid Stenosis, Cerebrovascular Disorders, Heart Diseases, Vascular Diseases

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.

Interventions

DRUGaspirin
DRUGdipyridamole

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Men and women who had recently undergone carotid endarterectomy.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026