Statin in Hip Fracture

Phase 3

Terminated

• Conditions: Hip Fracture
• Interventions: Drug: Placebo; Drug: Rosuvastatin

• Registration Number: NCT01494090
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-16
• Primary Completion: 2012-03
• Status Verified: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-19
• Last Update Posted: 2012-09-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	-
Rosuvastatin	Rosuvastatin	-

Primary Outcome Measures

Name	Time	Method
Occurence of Arterial and Venous Vascular Events and Mortality	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

Trial Locations

Locations (6)

APHP - Cochin Hospital; 🇫🇷 Paris, France

Brest, University Hospital; 🇫🇷 Brest, France

Caen, University Hospital; 🇫🇷 Caen, France

Grenoble, University Hospital; 🇫🇷 Grenoble, France

Quimper Hospital; 🇫🇷 Quimper, France

St-Etienne, University Hospital; 🇫🇷 St-Etienne, France