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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 months

Minor 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

Page last updated: August 23, 2015

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