Statin in Hip Fracture

Hip Fracture Clinical Trial

— STAFF  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01494090
• Other study ID #: RB 10-094 STAFF
• Status: Terminated
• Phase: Phase 3
• First received: December 15, 2011
• Last updated: September 19, 2012
• Start date: August 2011
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: September 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Drug:
• Rosuvastatin
5 or 20 mg per day during 6 months
• Placebo
5 or 20 mg per day during 6 months

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Brest	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of Arterial and Venous Vascular Events and Mortality	Nonfatal symptomatic thromboembolic venous desease; Acute coronary syndrome; Nonfatal ischemic stroke or transient ischemic attack; Acute peripheral arterial ischemia; Deaths from all causes	6 months	Yes