Statin in Hip Fracture

NCT ID: NCT01494090

Last Updated: 2012-09-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-09-30

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.

Conditions

Hip Fracture

Keywords

Venous thromboembolism; Hip fracture; Cardiovascular events; Statin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Rosuvastatin

Group Type: ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type: DRUG

5 or 20 mg per day during 6 months

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

5 or 20 mg per day during 6 months

Interventions

Rosuvastatin

5 or 20 mg per day during 6 months

Intervention Type: DRUG

Placebo

5 or 20 mg per day during 6 months

Intervention Type: DRUG

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominique MOTTIER

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Brest

Locations

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

Saint-Etienne, , France

Countries

France

Other Identifiers

RB 10-094 STAFF

Identifier Type: -

Identifier Source: org_study_id