Statin in Hip Fracture (STAFF)

This study has been terminated.
(Decision of the Steering Committee. Recruitment more difficult and slower than expected.)
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01494090
First received: December 15, 2011
Last updated: September 19, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Hip Fracture
Drug: Rosuvastatin
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • Occurence of Arterial and Venous Vascular Events and Mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    • Nonfatal symptomatic thromboembolic venous desease
    • Acute coronary syndrome
    • Nonfatal ischemic stroke or transient ischemic attack
    • Acute peripheral arterial ischemia
    • Deaths from all causes


Enrollment: 36
Study Start Date: August 2011
Study Completion Date: September 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rosuvastatin Drug: Rosuvastatin
5 or 20 mg per day during 6 months
Placebo Comparator: placebo Drug: Placebo
5 or 20 mg per day during 6 months

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494090

Locations
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, France
Sponsors and Collaborators
University Hospital, Brest
Ministry of Health, France
Investigators
Principal Investigator: Dominique MOTTIER University Hospital, Brest
  More Information

No publications provided

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01494090     History of Changes
Other Study ID Numbers: RB 10-094 STAFF
Study First Received: December 15, 2011
Last Updated: September 19, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Brest:
Venous thromboembolism
Hip fracture
Cardiovascular events
Statin

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014