EXCLAIM:Extended Prophylaxis for Venous ThromboEmbolism (VTE) in Acutely Ill Medical Patients With Prolonged Immobilization
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Venous Thromboembolism
Intervention: enoxaparin sodium (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s): Luc Sagnard, Study Director, Affiliation: Sanofi
Summary
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.
Clinical Details
Official title: A Double-Blind, Placebo-Controlled, Parallel, Multicenter Study on Extended VTE Prophylaxis in Acutely Ill Medical Patients With Prolonged Immobilization
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Primary outcome: 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: Occurrence of VTE between Day 1 and Day 90±10, Mortality at the end of Double-Blind Treatment, at 3 and 6 monthsMinor plus major hemorrhagic complications during Double-Blind Treatment.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Sanofi-Aventis, Buenos Aires, Argentina
Sanofi-Aventis, North Ryde, Australia
Sanofi-Aventis, Vienna, Austria
Sanofi-Aventis, Brussels, Belgium
Sanofi-Aventis, Sao Paulo, Brazil
Sanofi-Aventis, Laval, Canada
Sanofi-Aventis, Bogota, Colombia
Sanofi-Aventis, Paris, France
Sanofi-Aventis, Berlin, Germany
Sanofi-Aventis, Mumbai, India
Sanofi-Aventis, Natanya, Israel
Sanofi-Aventis, Milan, Italy
Sanofi-Aventis, Mexico, Mexico
Sanofi-Aventis, Warsaw, Poland
Sanofi-Aventis, Moscow, Russian Federation
Sanofi-Aventis, Johannesburg, South Africa
Sanofi-Aventis, Barcelona, Spain
Sanofi-Aventis, Megrine, Tunisia
Sanofi-Aventis, Guildford, United Kingdom
Sanofi-Aventis, Bridgewater, New Jersey, United States
Additional Information
Starting date: February 2002
Last updated: January 10, 2011
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