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Statin in Hip Fracture (STAFF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Rosuvastatin Drug: Rosuvastatin
5 or 20 mg per day during 6 months

Placebo Comparator: placebo Drug: Placebo
5 or 20 mg per day during 6 months

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 60 years old or older.
  • fracture of the femoral neck or of the trochanteric mass
  • undergoing surgery within 5 days for this fracture
  • Signed written informed consent

Exclusion Criteria:

  • contraindication to rosuvastatin:
  • active liver disease including unexplained and prolonged elevations of serum transaminases and any increase of serum transaminases beyond 3 times the upper limit of normal
  • severe renal impairment (creatinine clearance calculated by the formula MDRD <30 ml / min)
  • myopathy
  • use of cyclosporine
  • statin therapy ongoing at the admission for fracture
  • curative anticoagulant therapy ongoing at the admission and expected to be maintained after the intervention
  • Patients considered by the investigator to be unable to participate to the study
  • Refuse to participate

Information from the National Library of Medicine

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 identifier (NCT number): NCT01494090

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Brest, University Hospital
Brest, France
Caen, University Hospital
Caen, France
Grenoble, University Hospital
Grenoble, France
APHP - Cochin Hospital
Paris, France
Quimper Hospital
Quimper, France
St-Etienne, University Hospital
St-Etienne, France
Sponsors and Collaborators
University Hospital, Brest
Ministry of Health, France
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Principal Investigator: Dominique MOTTIER University Hospital, Brest

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Responsible Party: University Hospital, Brest Identifier: NCT01494090     History of Changes
Other Study ID Numbers: RB 10-094 STAFF
First Posted: December 16, 2011    Key Record Dates
Last Update Posted: September 20, 2012
Last Verified: September 2012

Keywords provided by University Hospital, Brest:
Venous thromboembolism
Hip fracture
Cardiovascular events

Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors