Clinical trial NCT01494090: Statin in Hip Fracture
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hip Fracture
Keywords: Venous thromboembolism
Hip fracture
Cardiovascular events
Statin
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2011-12-16
Enrollment: 36
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurence of Arterial and Venous Vascular Events and Mortality
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest, University Hospital
city: Caen
country: France
facility: Caen, University Hospital
city: Grenoble
country: France
facility: Grenoble, University Hospital
city: Paris
country: France
facility: APHP - Cochin Hospital
city: Quimper
country: France
facility: Quimper Hospital
city: St-Etienne
country: France
facility: St-Etienne, University Hospital
Study officials:
affiliation: University Hospital, Brest
name: Dominique MOTTIER
role: PRINCIPAL_INVESTIGATOR
References: