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

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00077753
• Other study ID #: XRP4563C_3501
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2004
• Last updated: January 10, 2011
• Start date: February 2002
• Est. completion date: February 2007

Study information

• Verified date: January 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4726
• Est. completion date: February 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• enoxaparin sodium

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Colombia,  France,  Germany,  India,  Israel,  Italy,  Mexico,  Poland,  Russian Federation,  South Africa,  Spain,  Tunisia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Occurrence of VTE between Day 1 and Day 90±10, Mortality at the end of Double-Blind Treatment, at 3 and 6 months
Secondary	Minor plus major hemorrhagic complications during Double-Blind Treatment.