Trial Outcomes & Findings for Pilot Study of Atorvastatin for Orthopedic Surgery Patients (NCT NCT02197065)
NCT ID: NCT02197065
Last Updated: 2017-07-02
Results Overview
The percentage of orthopedic patients with a ≥ 10 pg/mL rise in high-sensitivity cardiac troponin I (hs-cTnI) from baseline pre-operatively to post-operative day (POD)2
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
change from preoperative to postoperative day 2
Results posted on
2017-07-02
Participant Flow
Participant milestones
| Measure |
Atorvastatin
Atorvastatin 40mg daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
Atorvastatin: Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45
|
Sugar Pill
Sugar pill (placebo) daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of Atorvastatin for Orthopedic Surgery Patients
Baseline characteristics by cohort
| Measure |
Atorvastatin
n=10 Participants
Atorvastatin 40mg daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
Atorvastatin: Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45
|
Sugar Pill
n=10 Participants
Sugar pill (placebo) daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
Placebo
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 years
n=99 Participants
|
75 years
n=107 Participants
|
73 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Orthopedic procedure
Knee arthroplasty
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Orthopedic procedure
Hip arthroplasty
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Orthopedic procedure
Hip fracture repair
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: change from preoperative to postoperative day 2Population: 20 orthopedic surgery patients.
The percentage of orthopedic patients with a ≥ 10 pg/mL rise in high-sensitivity cardiac troponin I (hs-cTnI) from baseline pre-operatively to post-operative day (POD)2
Outcome measures
| Measure |
All Patients
n=20 Participants
All patients in the study
|
Sugar Pill
Sugar pill (placebo) daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
Placebo
|
|---|---|---|
|
Percentage of All Enrolled Patients With a Peri-operative Rise in High-sensitivity Cardiac Troponin I
|
20 percentage of patients
|
—
|
PRIMARY outcome
Timeframe: Change from preoperative to post-operative day 2The change in the level of hs-CRP from baseline to POD2 in 20 orthopedic patients randomized (1:1) to atorvastatin 40mg versus placebo.
Outcome measures
| Measure |
All Patients
n=10 Participants
All patients in the study
|
Sugar Pill
n=10 Participants
Sugar pill (placebo) daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
Placebo
|
|---|---|---|
|
Peri-operative Rise in High Sensitivity C-reactive Protein (Hs-CRP)
|
98.95 mg/L
Interval 63.8 to 151.4
|
85.95 mg/L
Interval 52.85 to 124.9
|
SECONDARY outcome
Timeframe: Change from preoperative to postoperative day 2Population: 16 arthroplasty patients
The change in the level of IL-6 from baseline to POD2 in 16 arthroplasty patients randomized (1:1) to atorvastatin 40mg versus placebo.
Outcome measures
| Measure |
All Patients
n=8 Participants
All patients in the study
|
Sugar Pill
n=8 Participants
Sugar pill (placebo) daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
Placebo
|
|---|---|---|
|
Peri-operative Rise in Interleukin-6 (IL-6) Levels
|
1.28 pg/mL
Interval 0.09 to 1.58
|
0.98 pg/mL
Interval 0.53 to 1.45
|
Adverse Events
Atorvastatin
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atorvastatin
n=10 participants at risk
Atorvastatin 40mg daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
Atorvastatin: Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45
|
Sugar Pill
n=10 participants at risk
Sugar pill (placebo) daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
Placebo
|
|---|---|---|
|
Vascular disorders
deep vein thrombosis
|
10.0%
1/10 • Number of events 1 • 90 days
|
0.00%
0/10 • 90 days
|
|
Cardiac disorders
Hypertension
|
10.0%
1/10 • Number of events 1 • 90 days
|
0.00%
0/10 • 90 days
|
|
Infections and infestations
bacteremia
|
0.00%
0/10 • 90 days
|
10.0%
1/10 • Number of events 1 • 90 days
|
|
Nervous system disorders
delirium
|
0.00%
0/10 • 90 days
|
10.0%
1/10 • Number of events 1 • 90 days
|
|
Metabolism and nutrition disorders
alcohol withdrawal
|
0.00%
0/10 • 90 days
|
10.0%
1/10 • Number of events 1 • 90 days
|
|
Cardiac disorders
fluid overload
|
0.00%
0/10 • 90 days
|
10.0%
1/10 • Number of events 1 • 90 days
|
Other adverse events
| Measure |
Atorvastatin
n=10 participants at risk
Atorvastatin 40mg daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
Atorvastatin: Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45
|
Sugar Pill
n=10 participants at risk
Sugar pill (placebo) daily starting at least 4 hours prior to hip fracture surgery, or 4 days prior to hip or knee arthroplasty, and continued until postoperative day 45.
Placebo
|
|---|---|---|
|
Infections and infestations
Infection
|
30.0%
3/10 • Number of events 4 • 90 days
|
20.0%
2/10 • Number of events 2 • 90 days
|
|
Nervous system disorders
delirium
|
20.0%
2/10 • Number of events 2 • 90 days
|
20.0%
2/10 • Number of events 2 • 90 days
|
|
Cardiac disorders
Hypertension
|
10.0%
1/10 • Number of events 1 • 90 days
|
10.0%
1/10 • Number of events 1 • 90 days
|
|
Cardiac disorders
Bradycardia
|
10.0%
1/10 • Number of events 1 • 90 days
|
0.00%
0/10 • 90 days
|
|
Nervous system disorders
neuropathy
|
0.00%
0/10 • 90 days
|
10.0%
1/10 • Number of events 1 • 90 days
|
|
Skin and subcutaneous tissue disorders
pruritis
|
0.00%
0/10 • 90 days
|
10.0%
1/10 • Number of events 1 • 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place