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

January 10, 2011 updated by: Sanofi

A Double-Blind, Placebo-Controlled, Parallel, Multicenter Study on Extended VTE Prophylaxis in Acutely Ill Medical Patients With Prolonged Immobilization

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

4726

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Sanofi-Aventis
  • Australia
      • North Ryde, Australia
        • Sanofi-Aventis
  • Austria
      • Vienna, Austria
        • Sanofi-Aventis
  • Belgium
      • Brussels, Belgium
        • Sanofi-Aventis
  • Brazil
      • Sao Paulo, Brazil
        • Sanofi-Aventis
  • Canada
      • Laval, Canada
        • Sanofi-Aventis
  • Colombia
      • Bogota, Colombia
        • Sanofi-Aventis
  • France
      • Paris, France
        • Sanofi-Aventis
  • Germany
      • Berlin, Germany
        • Sanofi-Aventis
  • India
      • Mumbai, India
        • Sanofi-Aventis
  • Israel
      • Natanya, Israel
        • Sanofi-Aventis
  • Italy
      • Milan, Italy
        • Sanofi-Aventis
  • Mexico
      • Mexico, Mexico
        • Sanofi-Aventis
  • Poland
      • Warsaw, Poland
        • Sanofi-Aventis
  • Russian Federation
      • Moscow, Russian Federation
        • Sanofi-Aventis
  • South Africa
      • Johannesburg, South Africa
        • Sanofi-Aventis
  • Spain
      • Barcelona, Spain
        • Sanofi-Aventis
  • Tunisia
      • Megrine, Tunisia
        • Sanofi-Aventis
  • United Kingdom
      • Guildford, United Kingdom
        • Sanofi-Aventis
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Luc Sagnard, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

February 12, 2004

First Submitted That Met QC Criteria

February 13, 2004

First Posted (Estimate)

February 16, 2004

Study Record Updates

Last Update Posted (Estimate)

January 11, 2011

Last Update Submitted That Met QC Criteria

January 10, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XRP4563C_3501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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