Statin in Hip Fracture

NCT01494090 | Terminated Phase 3 DMC

• 1 other identifier: RB 10-094 STAFF
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Rosuvastatin

ACTIVE COMPARATOR

Drug: Rosuvastatin

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Rosuvastatin DRUG

5 or 20 mg per day during 6 months

Rosuvastatin

Placebo DRUG

5 or 20 mg per day during 6 months

placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead
• Ministry of Health, France: collaborator

Study Sites (6)

Brest, University Hospital

Brest, France

Location

Caen, University Hospital

Caen, France

Location

Grenoble, University Hospital

Grenoble, France

Location

APHP - Cochin Hospital

Paris, France

Location

Quimper Hospital

Quimper, France

Location

St-Etienne, University Hospital

Saint-Etienne, France

Location

MeSH Terms

Conditions

Hip Fractures; Venous Thromboembolism

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dominique MOTTIER

  University Hospital, Brest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 16, 2011
• Study Start: August 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 20, 2012

Record last verified: 2012-09

Locations

FR (6)