Trial Outcomes & Findings for Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes (NCT NCT02850081)
NCT ID: NCT02850081
Last Updated: 2026-05-07
Results Overview
Neurocognitive assessments ≥2SD worse than reference group in two or more cognitive domains or (b) ≥1.5SD worse than the reference group in all cognitive domains. Due to early study termination and limited sample size, the study was not adequately powered to support inferential statistical comparisons. Therefore, outcome data are presented descriptively without formal statistical testing.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
31 participants
Primary outcome timeframe
30 Days: 1) Pre-op vs. Post-CEA Day 1 (12-25 hrs post-op) and 2) Pre-op vs. Post-CEA Day 30
Results posted on
2026-05-07
Participant Flow
Participant milestones
| Measure |
Statin-naive [Arm 4] Randomized to Atorvastatin 80mg
Patients on no statin regimen will be randomized to atorvastatin 80mg before CEA.
|
Maximal Dose [Arm 1]
Patients on a pre-existing maximal dose of either Simvastatin (40mg) with/without currently taking amlodipine (Norvasc) and those on Simvastatin 20mg while currently on amlodipine; Atorvastatin (80mg), or Rosuvastatin (20mg) regimen will be observed for \~2 weeks before their CEA.
|
Sub-maximal Dose [Arm 2]
Participants on a pre-existing sub-maximal statin regimen were randomized to either continue their current dose with matching placebo or escalate to the maximal dose of their current statin for approximately 2 weeks prior to CEA
|
Statin-naive [Arm 3] Randomized to Atorvastatin 10mg
Patients on no statin regimen will be randomized to atorvastatin 10mg before CEA.
|
|---|---|---|---|---|
|
Overall Study
COMPLETED
|
2
|
12
|
6
|
2
|
|
Overall Study
STARTED
|
2
|
18
|
9
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
3
|
0
|
Reasons for withdrawal
| Measure |
Statin-naive [Arm 4] Randomized to Atorvastatin 80mg
Patients on no statin regimen will be randomized to atorvastatin 80mg before CEA.
|
Maximal Dose [Arm 1]
Patients on a pre-existing maximal dose of either Simvastatin (40mg) with/without currently taking amlodipine (Norvasc) and those on Simvastatin 20mg while currently on amlodipine; Atorvastatin (80mg), or Rosuvastatin (20mg) regimen will be observed for \~2 weeks before their CEA.
|
Sub-maximal Dose [Arm 2]
Participants on a pre-existing sub-maximal statin regimen were randomized to either continue their current dose with matching placebo or escalate to the maximal dose of their current statin for approximately 2 weeks prior to CEA
|
Statin-naive [Arm 3] Randomized to Atorvastatin 10mg
Patients on no statin regimen will be randomized to atorvastatin 10mg before CEA.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
6
|
3
|
0
|
Baseline Characteristics
All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
Baseline characteristics by cohort
| Measure |
Maximal Dose [Arm 1]
n=18 Participants
Patients on a pre-existing maximal dose of either Simvastatin (40mg) with/without currently taking amlodipine (Norvasc) and those on Simvastatin 20mg while currently on amlodipine; Atorvastatin (80mg), or Rosuvastatin (20mg) regimen will be observed for \~2 weeks before their CEA.
|
Sub-maximal Dose [Arm 2]
n=9 Participants
Participants on a pre-existing sub-maximal statin regimen were randomized to either continue their current dose with matching placebo or escalate to the maximal dose of their current statin for approximately 2 weeks prior to CEA
|
Statin-naive [Arm 3] Randomized to Atorvastatin 10mg
n=2 Participants
Patients on no statin regimen will be randomized to atorvastatin 10mg before CEA.
|
Statin-naive [Arm 4] Randomized to Atorvastatin 80mg
n=2 Participants
Patients on no statin regimen will be randomized to atorvastatin 80mg before CEA.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
0 - 7 years old
|
0 Participants
n=54 Participants • All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
|
0 Participants
n=60 Participants • All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
|
0 Participants
n=114 Participants • All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
|
0 Participants
n=318 Participants • All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
|
0 Participants
n=280 Participants • All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
|
|
Age, Customized
8 - 17 years old
|
0 Participants
n=54 Participants • All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
|
0 Participants
n=60 Participants • All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
|
0 Participants
n=114 Participants • All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
|
0 Participants
n=318 Participants • All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
|
0 Participants
n=280 Participants • All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
2 Participants
n=280 Participants
|
|
Age, Customized
18 - 65 years old
|
2 Participants
n=54 Participants • All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
|
2 Participants
n=60 Participants • All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
|
1 Participants
n=114 Participants • All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
|
2 Participants
n=318 Participants • All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
|
7 Participants
n=280 Participants • All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
|
|
Age, Customized
> 65 years old
|
16 Participants
n=54 Participants • All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
|
7 Participants
n=60 Participants • All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
|
1 Participants
n=114 Participants • All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
|
0 Participants
n=318 Participants • All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
|
24 Participants
n=280 Participants • All participants who initiated the assigned intervention and underwent carotid endarterectomy (CEA) were included in the baseline analysis. Participants who did not undergo CEA were excluded.
|
|
Sex: Female, Male
Female
|
5 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
7 Participants
n=280 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=54 Participants
|
8 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
2 Participants
n=318 Participants
|
24 Participants
n=280 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
0 Participants
n=280 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
3 Participants
n=280 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
0 Participants
n=280 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=54 Participants
|
8 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
2 Participants
n=318 Participants
|
25 Participants
n=280 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
0 Participants
n=280 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
1 Participants
n=280 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
2 Participants
n=280 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=54 Participants
|
9 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
2 Participants
n=318 Participants
|
29 Participants
n=280 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
0 Participants
n=280 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=54 Participants
|
9 participants
n=60 Participants
|
2 participants
n=114 Participants
|
2 participants
n=318 Participants
|
31 participants
n=280 Participants
|
PRIMARY outcome
Timeframe: 30 Days: 1) Pre-op vs. Post-CEA Day 1 (12-25 hrs post-op) and 2) Pre-op vs. Post-CEA Day 30Population: Participants who did not undergo CEA were not analyzed and therefore not included here.
Neurocognitive assessments ≥2SD worse than reference group in two or more cognitive domains or (b) ≥1.5SD worse than the reference group in all cognitive domains. Due to early study termination and limited sample size, the study was not adequately powered to support inferential statistical comparisons. Therefore, outcome data are presented descriptively without formal statistical testing.
Outcome measures
| Measure |
Sub-maximal Dose [Arm 2]
n=6 Participants
Participants on a pre-existing sub-maximal statin regimen were randomized to either continue their current dose with matching placebo or escalate to the maximal dose of their current statin for approximately 2 weeks prior to CEA
|
Statin Naive - ARM 3 [Atorvastatin 10mg]
n=2 Participants
Patients on no statin regimen will be randomized to atorvastatin 10mg before CEA.
|
Statin Naive - ARM 4 [Atorvastatin 80mg]
n=2 Participants
Patients on no statin regimen will be randomized to atorvastatin 80mg before CEA.
|
Observational - Maximal Dose - ARM 1
n=12 Participants
Patients on a pre-existing maximal dose of either Simvastatin (40mg) with/without currently taking amlodipine (Norvasc) and those on Simvastatin 20mg while currently on amlodipine; Atorvastatin (80mg), or Rosuvastatin (20mg) regimen will be observed for \~2 weeks before their CEA.
|
|---|---|---|---|---|
|
Prevalence of eCD
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants who did not undergo CEA were not analyzed and therefore not included here.
Data will be collected by follow up phone call. Due to early study termination and limited sample size, the study was not adequately powered to support inferential statistical comparisons. Therefore, outcome data are presented descriptively without formal statistical testing.
Outcome measures
| Measure |
Sub-maximal Dose [Arm 2]
n=6 Participants
Participants on a pre-existing sub-maximal statin regimen were randomized to either continue their current dose with matching placebo or escalate to the maximal dose of their current statin for approximately 2 weeks prior to CEA
|
Statin Naive - ARM 3 [Atorvastatin 10mg]
n=2 Participants
Patients on no statin regimen will be randomized to atorvastatin 10mg before CEA.
|
Statin Naive - ARM 4 [Atorvastatin 80mg]
n=2 Participants
Patients on no statin regimen will be randomized to atorvastatin 80mg before CEA.
|
Observational - Maximal Dose - ARM 1
n=12 Participants
Patients on a pre-existing maximal dose of either Simvastatin (40mg) with/without currently taking amlodipine (Norvasc) and those on Simvastatin 20mg while currently on amlodipine; Atorvastatin (80mg), or Rosuvastatin (20mg) regimen will be observed for \~2 weeks before their CEA.
|
|---|---|---|---|---|
|
Prevalence of Early Mortality
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Maximal Dose [Arm 1]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sub-maximal Dose [Arm 2]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Statin Naive - ARM 3 [Atorvastatin 10mg]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Statin Naive - ARM 4 [Atorvastatin 80mg]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place