Carotid Revascularization for Primary Prevention of Stroke (CREST-2)
Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Carotid Revascularization for Primary Prevention of Stroke|
- Stroke and death [ Time Frame: 4 years ] [ Designated as safety issue: No ]The primary outcome is the composite of stroke plus death within 30 days after randomization and ipsilateral stroke thereafter up to 4 years.
- Cognitive Function [ Time Frame: 4 years ] [ Designated as safety issue: No ]The assess if MEDICAL management differs from CAS, and differs from CEA, to maintain the level of cognitive function at the 4-year assessment.
- Major Stroke [ Time Frame: 4 years ] [ Designated as safety issue: No ]if there are treatment differences in the incidence of major stroke at 4-years among all arms of the study
- Effect modification [ Time Frame: 4 years ] [ Designated as safety issue: No ]Potential effect modification of the CAS or CEA versus MEDICAL differences, based on patient age, sex, severity of carotid stenosis, restenosis, risk factor level, and duration of asymptomatic period.
|Study Start Date:||October 2014|
|Estimated Primary Completion Date:||December 2020 (Final data collection date for primary outcome measure)|
Active Comparator: Carotid Endarterectomy (CEA)
|Procedure: Carotid endarterectomy|
Active Comparator: Carotid Stenting (CAS)
|Device: Carotid stenting|
No Intervention: Medical
Intensive medical management
Prevention of stroke involves managing and treating risk factors. Most strokes are caused when blood flow to a portion of the brain is blocked. One place this often happens is in the carotid artery. This blockage is called atherosclerosis or hardening of the arteries.
The purpose of this trial is to determine the best way to prevent strokes in people who have a high amount of blockage of their carotid artery but no stroke symptoms related to that blockage. Each eligible participant will be evaluated to determine which procedure(s) is best for him/her. All participants will receive intensive medical treatment. In addition, participants will be randomized to receive the selected procedure or not.
The trial will be conducted in the United States and Canada by physicians carefully selected on their ability to perform the procedures at low risk. Another key component of the trial is that important stroke risk factors, including hypertension, diabetes, high cholesterol, cigarette smoking, physical activity, and diet will be managed intensively. Participants will remain in the study for 4 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02089217
|Contact: CREST-2 Administrative Center||844-956-1826|
|Principal Investigator:||Thomas G. Brott, MD||Mayo Clinic Florida|
|Principal Investigator:||James F. Meschia, MD||Mayo Clinic Florida|
|Principal Investigator:||Brajesh K. Lal, MD||University of Maryland|
|Principal Investigator:||George Howard, DrPH||University of Alabama at Birmingham|