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EXCLAIM:Extended Prophylaxis for Venous ThromboEmbolism (VTE) in Acutely Ill Medical Patients With Prolonged Immobilization

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00077753
First received: February 12, 2004
Last updated: January 10, 2011
Last verified: January 2011
  Purpose

Primary objective:

  • To demonstrate the superiority of extended VTE prophylaxis with enoxaparin 40mg sc qd for 28 ± 4 days, compared to placebo, both following 10 ± 4 days of initial treatment with enoxaparin 40mg sc qd

Secondary objectives:

  • To assess the reduction in mortality rate at the end of the double-blind treatment period, at 3 (90 ± 10 days) and at 6 (180 ± 10 days) months from the time of entry to the study, in patients on extended prophylaxis
  • To assess the incidence of VTE at 3 months (90 ± 10 days) from the time of randomization to the study
  • To evaluate the safety of extended enoxaparin VTE prophylaxis in acutely ill medical patients with prolonged immobilization. Safety evaluation includes:

    • Major and minor hemorrhage
    • Heparin induced thrombocytopenia
    • Serious adverse events
  • To assess differences in levels of health-care utilization and cost between patients receiving extended VTE prophylaxis versus those receiving placebo.

Condition Intervention Phase
Venous Thromboembolism
Drug: enoxaparin sodium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Double-Blind, Placebo-Controlled, Parallel, Multicenter Study on Extended VTE Prophylaxis in Acutely Ill Medical Patients With Prolonged Immobilization

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • During double blind treatment : Cumulative occurrence of VTE assessed by ultrasound for all patients at 28±4 days after randomization (or earlier if symptomatic VTE) and/or V/Q lung scan for symptomatic patients ; Major hemorrhagic complications.

Secondary Outcome Measures:
  • Occurrence of VTE between Day 1 and Day 90±10, Mortality at the end of Double-Blind Treatment, at 3 and 6 months
  • Minor plus major hemorrhagic complications during Double-Blind Treatment.

Estimated Enrollment: 4726
Study Start Date: February 2002
Study Completion Date: February 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion criteria:

  • Recent immobilization ≤ 3 days
  • Level 1 mobility patients who are ≥ 40 years of age with acute medical illness or acute exacerbation of chronic medical illness
  • Level 2 mobility patients who

    • are >75 yrs of age
    • are ≥ 40 years of age and have a history of VTE (deep venous thrombosis or pulmonary embolism)
    • are ≥ 40 years of age and have a baseline diagnosis of cancer (active cancer or history of cancer)

Anticipated decreased level of mobility of 5 ± 2 days with a level of activity 1 and 2 at the time of study entry and likely to continue at a lower than pre-morbid activity level after the initial 5 ± 2 day period. PATIENTS DO NOT HAVE TO BE HOSPITALIZED IN ORDER TO BE INCLUDED IN THE STUDY.(Definition of decreased level of mobility: _Level 1:bed rest or sedentary patients _Level 2:level 1 with bathroom privileges)

  • Presence of at least one of the following medical conditions:

    • Heart Failure, NYHA class III and IV

      • Class III : Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitationdyspnea, or anginal pain.
      • Class IV : Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
    • Acute respiratory insufficiency
    • Other acute medical conditions such as:

      • Acute ischemic stroke, any territory, with an appropriate neuroradiologic (head CT scan or brain MRI scan) providing results consistent with non hemorrhagic stroke
      • acute infection without septic shock
      • acute rheumatic disorders
      • active episode of inflammatory bowel disease
      • active cancer defined as history of histologically or cytologically confirmed cancer in patients who are not candidates for debulking or curative intent surgery at study entry
      • Any other acute medical illness or exacerbation of chronic medical illness resulting in clinically significant reduction in mobility as compared to premorbid level.

Exclusion criteria:

  • Women who are breastfeeding, pregnant or of childbearing age and not using medically acceptable effective contraception
  • Patients with any evidence of an active bleeding disorder
  • Contraindication to anticoagulation
  • Major surgery within the previous 3 months
  • Patients who have had spinal or epidural analgesia or lumbar puncture within the preceding 24 hours
  • Known hypersensitivity to heparin, or LMWH, or pork derived products
  • A documented previous episode of heparin-induced or LMWH induced thrombocytopenia and/or thrombosis (HIT, HAT, or HITTS)
  • Patients who have taken part in another clinical trial within the previous thirty days
  • Patients with a persistent renal failure. The patient's creatinine level must be less than the creatinine level per gender/age/weight. This will replace the calculated creatinine clearance
  • Known or suspected severe anemia of unexplained cause considered clinically relevant by investigator
  • Patients with prosthetic heart valves
  • Patients with known cerebral metastases
  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: NCT00077753

  Show 20 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Luc Sagnard Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00077753     History of Changes
Other Study ID Numbers: XRP4563C_3501
Study First Received: February 12, 2004
Last Updated: January 10, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014