Hip FracturePhase 2POST-OP PilotNCT02197065
Pilot Study of Atorvastatin for Orthopedic Surgery Patients
A Phase 2 study testing Atorvastatin in people with Hip Fracture and Myocardial Ischemia, run by Hospital for Special Surgery, New York at 2 sites in United States.
Trial summary
Up to 35% of hip fracture patients have been shown to experience heart injury after surgery, and as many as 10% have a heart attack or die in the three months after surgery. Hip and knee arthroplasty patients are also at risk of cardiovascular complications. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Hip Fracture, Myocardial Ischemia, Inflammation
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to Jan 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Hip fracture or elective hip or knee arthroplasty
- Age 65 years or older
- Life expectancy > 3 months
Who cannot join
- Pathological hip fracture due to cancer
- Currently taking a statin, or took a statin within the last 30 days
- Previous statin intolerance
- Acute myocardial infarction or unstable angina
- History of myocardial infarction, acute coronary syndrome, angina, coronary/arterial re-vascularization
- Hip fracture patients with peripheral arterial disease
Show all 13Show fewer
- Hip fracture patients with history of stroke or transient ischemic attack.
- Muscle disorder
- Serious liver disease or alanine aminotransferase > 3x upper limit of normal
- Serious renal disease (creatinine clearance <30cc/min)
- Treatment with HIV protease inhibitor or Hepatitis C protease inhibitor
- Treatment with erythromycin, clarithromycin, niacin or azole antifungal agent
- Pregnant, planning to become pregnant, or breastfeeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hospital for Special Surgery
New York, New York, 10021
New York Presbyterian Hospital (Cornell)
New York, New York, 10065
About this study
Official title: The Post-Operative Statin for Thromboprophylaxis & Cardiovascular Outcomes Protection (POST-OP) Pilot Trial
Up to 35% of hip fracture patients have been shown to experience heart injury after surgery, and as many as 10% have a heart attack or die in the three months after surgery. Hip and knee arthroplasty patients are also at risk of cardiovascular complications. Patients who have these complications have higher levels of inflammation postoperatively. Statins (such as atorvastatin/Lipitor) lower cholesterol and also lessen inflammation. Both of these effects are important in preventing heart attacks. Statins have been shown to reduce the risk of heart attacks in non-surgical patients, and to protect from heart attacks in patients having heart surgery. Whether statins can prevent heart attacks in orthopedic patients is not known.
In this pilot study the investigators will treat 30 orthopedic surgery patients (hip fracture, hip or knee arthroplasty) with either atorvastatin or placebo (a capsule with no study drug). Patients will start the study drug prior to surgery and take it for 45 days after surgery. Neither the doctors nor the patients will know whether they are taking atorvastatin or placebo. The investigators will look for evidence of inflammation and heart injury after surgery. The investigators hypothesize that atorvastatin will lessen the degree of postoperative inflammation found in these patients. In this study, the investigators will use a very sensitive test of heart injury that can detect problems even when patients have no symptoms. The investigators hypothesize that this test will demonstrate silent heart injury in over 50% of the hip fracture patients and over 30% of arthroplasty patients in our study.
The results of this trial will help us to develop a larger study in 1000 hip fracture and joint replacement patients to determine whether atorvastatin protects orthopedic surgery patients from heart injury and other complications of surgery.
Read the detailed description
- Thirty statin-naïve patients ≥ 65 years of age admitted to New York Presbyterian Hospital or Hospital for Special Surgery with an acute hip fracture, or for elective hip or knee arthroplasty will be randomized in a 1:1 ratio to atorvastatin 40 mg daily or matching placebo.
- Atorvastatin will be initiated at least 4 hours prior to hip fracture surgery, or 4 days prior to arthroplasty, and will be continued until postoperative day (POD) 45.
- Patients will be assessed daily in the hospital for adverse events.
- Patients will be contacted by telephone weekly for four weeks after surgery and again on POD 45 and POD 90.
- Patients will mail back study medication bottles on POD 45 for pill counts to assess compliance.
- High sensitivity cardiac troponin I (hs-cTnI) will be measured pre-operatively (prior to atorvastatin therapy) and on POD 2.
- High sensitivity C-reactive protein (hs-CRP), and a panel of cytokines (IL-1β, IL-2, IL-2r, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-17, tumor necrosis factor (TNF)-α, interferon (IFN)-γ, and soluble (s)CD-40L) will be measured preoperatively and on POD 2.
- Conditions
- Hip Fracture, Myocardial Ischemia, Inflammation
- Being tested
- Atorvastatin, Placebo
- Keywords
- hip fracture, myocardial ischemia, statin, surgery, troponin, complication, arthroplasty, hip, knee, orthopedic, atorvastatin, cardiovascular
- Medical subject headings
- Hip Fractures, Myocardial Ischemia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor
Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | 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. Receives: Drug: Atorvastatin |
| Sugar pill | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of All Enrolled Patients With a Peri-operative Rise in High-sensitivity Cardiac Troponin I
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
Measured: change from preoperative to postoperative day 2
Peri-operative Rise in High Sensitivity C-reactive Protein (Hs-CRP)
The change in the level of hs-CRP from baseline to POD2 in 20 orthopedic patients randomized (1:1) to atorvastatin 40mg versus placebo.
Measured: Change from preoperative to post-operative day 2
Secondary outcomes (1)
Peri-operative Rise in Interleukin-6 (IL-6) Levels
The change in the level of IL-6 from baseline to POD2 in 16 arthroplasty patients randomized (1:1) to atorvastatin 40mg versus placebo.
Measured: Change from preoperative to postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, Washington University School of Medicine, University of Utah
- Responsible party
- Sponsor
- Investigators
- Anne R Bass, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197065
- Sponsor's protocol ID
- EPAR4398
- Other IDs
- UL1TR000457-06
- Acronym
- POST-OP Pilot
- Status last verified
- Apr 2017
- First submitted
- 21 Jul 2014
- Last updated
- 2 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bass AR, Szymonifka JD, Rondina MT, Bogardus M, Scott MG, Woller SC, Stevens SM, Eby C, Merritt K, Valle AGD, Moskowitz G, Flores E, Gage BF. Postoperative Myocardial Injury and Inflammation Is Not Blunted by a Trial of Atorvastatin in Orthopedic Surgery Patients. HSS J. 2018 Feb;14(1):67-76. doi: 10.1007/s11420-017-9577-1. Epub 2017 Oct 13.
PubMed 29398998
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Post-Operative Statin for Thromboprophylaxis & Cardiovascular Outcomes Protection (POST-OP) Pilot Trial
- ClinicalTrials.gov ID
- NCT02197065
- Acronym / sponsor ID
- POST-OP Pilot / EPAR4398
- Conditions
- Hip Fracture, Myocardial Ischemia, Inflammation
- Keywords
- hip fracture, myocardial ischemia, statin, surgery, troponin, complication, arthroplasty, hip
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, Washington University School of Medicine, University of Utah
- Study start
- Sep 2014 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Posted 2 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Up to 35% of hip fracture patients have been shown to experience heart injury after surgery, and as many as 10% have a heart attack or die in the three months after surgery. Hip and knee arthroplasty patients are also at risk of cardiovascular complications. Patients who have these complications have higher levels of inflammation postoperatively. Statins (such as atorvastatin/Lipitor) lower cholesterol and also lessen inflammation. Both of these effects are important in preventing heart attacks. Statins have been shown to reduce the risk of heart attacks in non-surgical patients, and to protect from heart attacks in patients having heart surgery. Whether statins can prevent heart attacks in orthopedic patients is not known.
In this pilot study the investigators will treat 30 orthopedic surgery patients (hip fracture, hip or knee arthroplasty) with either atorvastatin or placebo (a capsule with no study drug). Patients will start the study drug prior to surgery and take it for 45 days after surgery. Neither the doctors nor the patients will know whether they are taking atorvastatin or placebo. The investigators will look for evidence of inflammation and heart injury after surgery. The investigators hypothesize that atorvastatin will lessen the degree of postoperative inflammation found in these patients. In this study, the investigators will use a very sensitive test of heart injury that can detect problems even when patients have no symptoms. The investigators hypothesize that this test will demonstrate silent heart injury in over 50% of the hip fracture patients and over 30% of arthroplasty patients in our study.
The results of this trial will help us to develop a larger study in 1000 hip fracture and joint replacement patients to determine whether atorvastatin protects orthopedic surgery patients from heart injury and other complications of surgery.
Detailed description
- Thirty statin-naïve patients ≥ 65 years of age admitted to New York Presbyterian Hospital or Hospital for Special Surgery with an acute hip fracture, or for elective hip or knee arthroplasty will be randomized in a 1:1 ratio to atorvastatin 40 mg daily or matching placebo.
- Atorvastatin will be initiated at least 4 hours prior to hip fracture surgery, or 4 days prior to arthroplasty, and will be continued until postoperative day (POD) 45.
- Patients will be assessed daily in the hospital for adverse events.
- Patients will be contacted by telephone weekly for four weeks after surgery and again on POD 45 and POD 90.
- Patients will mail back study medication bottles on POD 45 for pill counts to assess compliance.
- High sensitivity cardiac troponin I (hs-cTnI) will be measured pre-operatively (prior to atorvastatin therapy) and on POD 2.
- High sensitivity C-reactive protein (hs-CRP), and a panel of cytokines (IL-1β, IL-2, IL-2r, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-17, tumor necrosis factor (TNF)-α, interferon (IFN)-γ, and soluble (s)CD-40L) will be measured preoperatively and on POD 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Drug: AtorvastatinAtorvastatin 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. |
| Sugar pill | Placebo comparator | Drug: PlaceboSugar 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. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Hip fracture or elective hip or knee arthroplasty
- Age 65 years or older
- Life expectancy > 3 months
Key exclusion criteria (13 listed)
- Pathological hip fracture due to cancer
- Currently taking a statin, or took a statin within the last 30 days
- Previous statin intolerance
- Acute myocardial infarction or unstable angina
- History of myocardial infarction, acute coronary syndrome, angina, coronary/arterial re-vascularization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: LipitorAtorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45 | Drug | Atorvastatin |
| Placebo | Drug | Sugar pill |
Primary outcome
Percentage of All Enrolled Patients With a Peri-operative Rise in High-sensitivity Cardiac Troponin I
Time frame: change from preoperative to postoperative day 2
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
Peri-operative Rise in High Sensitivity C-reactive Protein (Hs-CRP)
Time frame: Change from preoperative to post-operative day 2
The change in the level of hs-CRP from baseline to POD2 in 20 orthopedic patients randomized (1:1) to atorvastatin 40mg versus placebo.
1 secondary outcome
Peri-operative Rise in Interleukin-6 (IL-6) Levels
Time frame: Change from preoperative to postoperative day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29398998Bass AR, Szymonifka JD, Rondina MT, Bogardus M, Scott MG, Woller SC, Stevens SM, Eby C, Merritt K, Valle AGD, Moskowitz G, Flores E, Gage BF. Postoperative Myocardial Injury and Inflammation Is Not Blunted by a Trial of Atorvastatin in Orthopedic Surgery Patients. HSS J. 2018 Feb;14(1):67-76. doi: 10.1007/s11420-017-9577-1. Epub 2017 Oct 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne R Bass, MD principal investigator
Hospital for Special Surgery, New York
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin in people with Hip Fracture and Myocardial Ischemia, run by Hospital for Special Surgery, New York at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of All Enrolled Patients With a Peri-operative Rise in High-sensitivity Cardiac Troponin I (time frame: change from preoperative to postoperative day 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02197065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017; AzTrials last refreshed its copy on 7 Nov 2026.