Statin in Hip Fracture (STAFF)
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|ClinicalTrials.gov Identifier: NCT01494090|
Recruitment Status : Terminated (Decision of the Steering Committee. Recruitment more difficult and slower than expected.)
First Posted : December 16, 2011
Last Update Posted : September 20, 2012
Statins (or HMG-CoA reductase inhibitors) have largely proven their efficacy in the primary and secondary prevention of cardiovascular events. Many clinical and experimental studies support also a potential beneficial effect of statin therapy on venous thromboembolism (VTE). Patients with hip fracture are at high risk of VTE and cardiovascular events.
The aim of this study is to evaluate the efficacy and the tolerance of a statin (rosuvastatin) in hip fracture surgery on the occurrence of venous and atherothrombotic events and the global mortality at six months.
Subjects aged 60 years or over who are scheduled to undergo surgery for fracture of the upper portion of the femur (hip fracture) are eligible to participate to this multicentre, randomized, double-blind placebo controlled trial. They will receive either rosuvastatin (5 or 20 mg) or placebo for 6 months. The primary efficacy outcome is the incidence of an adjudicated composite of non fatal VTE, acute coronary syndrome, non fatal stroke, other acute ischemic arterial event, or all-cause death.
Assuming a endpoint frequency of 20% in the control group, we calculated that 1200 patients will be required for the study to have 80% power to detect a 30% reduction in the relative risk with rosuvastatin (with a two-sided alpha level of 5%).
The investigators assumed that rosuvastatin could have a positive benefit-risk ratio in patients undergoing orthopaedic surgery for hip fracture, by reducing vascular events and global mortality at six months.
|Condition or disease||Intervention/treatment||Phase|
|Hip Fracture||Drug: Rosuvastatin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy and Safety of Rosuvastatin in the Prevention of Arterial and Venous Vascular Events and Mortality After Hip Fracture: A Multicenter Randomised, Double-blinded, Placebo Controlled Trial.|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||September 2012|
|Active Comparator: Rosuvastatin||
5 or 20 mg per day during 6 months
|Placebo Comparator: placebo||
5 or 20 mg per day during 6 months
- Occurence of Arterial and Venous Vascular Events and Mortality [ Time Frame: 6 months ]
- Nonfatal symptomatic thromboembolic venous desease
- Acute coronary syndrome
- Nonfatal ischemic stroke or transient ischemic attack
- Acute peripheral arterial ischemia
- Deaths from all causes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01494090
|Brest, University Hospital|
|Caen, University Hospital|
|Grenoble, University Hospital|
|APHP - Cochin Hospital|
|St-Etienne, University Hospital|
|Principal Investigator:||Dominique MOTTIER||University Hospital, Brest|