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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00077753




Registration number
NCT00077753
Ethics application status
Date submitted
12/02/2004
Date registered
16/02/2004
Date last updated
11/01/2011

Titles & IDs
Public title
EXCLAIM:Extended Prophylaxis for Venous ThromboEmbolism (VTE) in Acutely Ill Medical Patients With Prolonged Immobilization
Scientific title
A Double-Blind, Placebo-Controlled, Parallel, Multicenter Study on Extended VTE Prophylaxis in Acutely Ill Medical Patients With Prolonged Immobilization
Secondary ID [1] 0 0
XRP4563C_3501
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - enoxaparin sodium

Treatment: Drugs: enoxaparin sodium
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Occurrence of VTE between Day 1 and Day 90±10, Mortality at the end of Double-Blind Treatment, at 3 and 6 months
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Minor plus major hemorrhagic complications during Double-Blind Treatment.
Timepoint [2] 0 0

Eligibility
Key inclusion 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.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis - North Ryde
Recruitment postcode(s) [1] 0 0
- North Ryde
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Austria
State/province [3] 0 0
Vienna
Country [4] 0 0
Belgium
State/province [4] 0 0
Brussels
Country [5] 0 0
Brazil
State/province [5] 0 0
Sao Paulo
Country [6] 0 0
Canada
State/province [6] 0 0
Laval
Country [7] 0 0
Colombia
State/province [7] 0 0
Bogota
Country [8] 0 0
France
State/province [8] 0 0
Paris
Country [9] 0 0
Germany
State/province [9] 0 0
Berlin
Country [10] 0 0
India
State/province [10] 0 0
Mumbai
Country [11] 0 0
Israel
State/province [11] 0 0
Natanya
Country [12] 0 0
Italy
State/province [12] 0 0
Milan
Country [13] 0 0
Mexico
State/province [13] 0 0
Mexico
Country [14] 0 0
Poland
State/province [14] 0 0
Warsaw
Country [15] 0 0
Russian Federation
State/province [15] 0 0
Moscow
Country [16] 0 0
South Africa
State/province [16] 0 0
Johannesburg
Country [17] 0 0
Spain
State/province [17] 0 0
Barcelona
Country [18] 0 0
Tunisia
State/province [18] 0 0
Megrine
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Guildford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00077753
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Luc Sagnard
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00077753