Study to Evaluate the Mortality Reduction of Enoxaparin in Hospitalized Acutely Ill Medical Receiving Enoxaparin (LIFENOX)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00622648
First received: February 14, 2008
Last updated: December 27, 2010
Last verified: December 2010
  Purpose

The primary objective:

  • To demonstrate in patients hospitalized for an acute medical illness that enoxaparin with Graduated Elastic Stockings is superior to enoxaparin-placebo with Graduated Elastic Stockings on overall mortality at day 30 after randomization.

The secondary objective:

  • To compare, in patients hospitalized for an acute medical illness, enoxaparin with Graduated Elastic Stockings versus enoxaparin placebo with Graduated Elastic Stockings on overall mortality at day 90 after randomization.
  • To evaluate the safety of enoxaparin VTE prophylaxis in patients hospitalized for acute medical illness with respect to major hemorrhage, total bleedings, heparin induced thrombocytopenia, adverse events and serious adverse events .

Condition Intervention Phase
Acute Illness
Drug: Enoxaparin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: International, Multi-center, Randomized, Double Blind Study to Compare the Overall Mortality in Acutely Ill Medical Patients Treated With Enoxaparin Versus Placebo in Addition to Graduated Elastic Stockings

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Death rate with all causes mortality [ Time Frame: At day 30 ] [ Designated as safety issue: No ]
  • Hemorrhages [ Time Frame: Occuring until day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: Between randomization and day 90 ] [ Designated as safety issue: No ]
  • Adverse events, serious adverse events [ Time Frame: During the entire observation period (from informed consent signature until Day 90) ] [ Designated as safety issue: No ]

Enrollment: 8329
Study Start Date: January 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Enoxaparin: 40 mg once daily for 6 to 14 days (10 ± 4 days)
Drug: Enoxaparin
40 mg once daily for 6 to 14 days (10 ± 4 days)
Placebo Comparator: B
Enoxaparin placebo 40mg once daily for 6 to 14 days (10 ± 4 days)
Drug: Placebo
Enoxaparin placebo 40mg once daily for 6 to 14 days (10 ± 4 days)

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

List of inclusion and exclusion criteria

Inclusion Criteria:

  • Hospitalization within 48 hours prior randomization for at least one of the following medical acute medical illness:

    • Acute decompensation of heart failure
    • Severe systemic infection and at least one of the following:

      • Chronic pulmonary diseases (COPD, pulmonary fibrosis, pulmonary restrictive syndrome…)
      • Obesity (BMI ≥ 30kg/m2)
      • Personal history of VTE
      • Age ≥ 60 years
    • Active cancer (defined as being histologically confirmed with an initial diagnosis or recurrence or metastasis within the past 6 months) excluding planned hospitalization for chemotherapy
  • Anticipated duration of hospitalization at least 6 days
  • Health status:

    • ASA Health status score ≤ 3 (American Society of Anesthesiologists)
    • ECOG ≤ 2 in cancer patient
  • Anticipated life expectancy > 1 week

Exclusion criteria:

  • Major surgery or major trauma within the previous 6 weeks (orthopedic or trauma surgery to the lower extremities, gastrointestinal tract, urological, chest, gynecological surgery)
  • Need for any ventilatory support (with intubation required)
  • Symptomatic VTE at enrollment
  • Multi organ failure
  • Evidence of an active bleeding disorder
  • Contraindication to anticoagulation:

    • Coagulopathy (acquired or inherited)
    • Neurosurgery within the past day 30
    • History of cerebral hemorrhage at any time
    • Known bacterial endocarditis
    • Uncontrolled arterial hypertension (systolic BP > 200 mmHg or diastolic BP > 110 mm Hg) at 2 successive readings
    • Haemostatic abnormalities: baseline platelet count <50,000/mm3, activated partial thromboplastin time (aPTT) 1.5x the upper limit of normal, or International Normalized Ratio (INR) > 1.5
    • Indication for thrombolytic therapy
    • Need for a curative treatment of anticoagulant therapy (low molecular weight heparin, unfractionated heparin, oral anticoagulant therapy)
    • Receiving LMWH or UFH at prophylactic doses for more than 72 hours prior to inclusion (patients receiving LMWH or UFH at prophylactic doses for 72 hours or less prior to entry may be included in the study)
    • Oral anticoagulant therapy within 72 hours prior to inclusion
  • Cerebrovascular accident at inclusion and within 10 days prior study inclusion
  • Prosthetic heart valves
  • Confirmed cerebral metastases
  • Known hypersensitivity to heparin or LMWH, or pork-derived products
  • History of documented episode of heparin, or LMWH induced thrombocytopenia, and/or thrombosis (HIT, HAT, or HITTS)
  • Participating in another clinical trial within the previous 30 days (patients with cancer included in a cancer treatment protocol are authorized to participate)
  • Persistent renal failure (defined as a documented value of calculated creatinine clearance < 30 mL/min on at least 2 occasions ³3 days prior to entry into the study)
  • Known or suspected severe anemia of unexplained cause considered clinically relevant by investigator
  • Spinal or epidural analgesia or lumbar puncture within the preceding 24 hours
  • Unlikely to be compliant (e.g. alcohol, drug abuse)
  • Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling to be tested for pregnancy (pregnancy status should be checked by serum or urine pregnancy testing prior to exposure to the investigational product)
  • Refusal or inability to give informed consent to participate in the study
  • Inability to be followed-up after discharge until day 90 after randomization

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  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: NCT00622648

Locations
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
China
Sanofi-Aventis Administrative Office
Shanghai, China
Hong Kong
Sanofi-Aventis Administrative Office
Hong Kong, Hong Kong
India
Sanofi-Aventis Administrative Office
Mumbai, India
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Malaysia
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Mexico
Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
Philippines
Sanofi-Aventis Administrative Office
Makati City, Philippines
Tunisia
Sanofi-Aventis Administrative Office
Megrine, Tunisia
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Bruno DESLANDES Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Trial Transparency Team, Sanofi-aventis
ClinicalTrials.gov Identifier: NCT00622648     History of Changes
Other Study ID Numbers: ENOXA_C_01249
Study First Received: February 14, 2008
Last Updated: December 27, 2010
Health Authority: Malaysia: Ministry of Health

Keywords provided by Sanofi:
Medical prevention therapy

ClinicalTrials.gov processed this record on October 01, 2014