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NCT02197065 · ClinicalTrials.gov registry record · Phase 2
Pilot Study of Atorvastatin for Orthopedic Surgery Patients
A Phase 2 study, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT02197065: Completed Phase 2 study, sponsored by Hospital for Special Surgery, New York.
NCT02197065 is a Phase 2 study that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02197065, a Phase 2 study, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG Atorvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-09 |
| Est. Completion | 2017-01 |
| Phase | Phase 2 |
What the finished NCT02197065 record still lists
NCT02197065 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02197065 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02197065 about?
NCT02197065 is a clinical study titled "Pilot Study of Atorvastatin for Orthopedic Surgery Patients". 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 hav...
What is the current status of trial NCT02197065?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2014-09. Estimated completion is 2017-01.
What interventions are being tested in trial NCT02197065?
The interventions under investigation include: Placebo (DRUG), Atorvastatin (DRUG).
Who is sponsoring clinical trial NCT02197065?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02197065's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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