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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/NCT00077805




Registration number
NCT00077805
Ethics application status
Date submitted
12/02/2004
Date registered
16/02/2004
Date last updated
11/01/2011

Titles & IDs
Public title
PREVAIL: PREvention of VTE After Acute Ischemic Stroke With LMWH Enoxaparin ( - VTE: Venous Thromboembolism - LMWH: Low Molecular Weight Heparin)
Scientific title
An Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Efficacy and Safety of Enoxaparin Versus Unfractionated Heparin in the Prevention of Venous Thromboembolism in Patients Following Acute Ischemic Stroke
Secondary ID [1] 0 0
XRP4563H_4001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Ischemic Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders
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
Cumulative occurrence of VTE events (deep-vein thrombosis, pulmonary embolism)
Timepoint [1] 0 0
10 ± 4 days following acute ischemic stroke
Secondary outcome [1] 0 0
cumulative VTE events
Timepoint [1] 0 0
at 30-day, 60-day and 90-day
Secondary outcome [2] 0 0
stroke recurrence, stroke progression, National Institute of Health Stroke Scale (NIHSS) scores
Timepoint [2] 0 0
during treatment and follow-up periods
Secondary outcome [3] 0 0
Modified Rankin Scale (MRS) scores
Timepoint [3] 0 0
at 30-day and 90-day follow-up
Secondary outcome [4] 0 0
major & minor hemorrhages
Timepoint [4] 0 0
from the inform consent signed up to the end of the study
Secondary outcome [5] 0 0
Treatment emergent adverse events (TEAE), serious adverse events (SAE), all-cause mortality
Timepoint [5] 0 0
from the inform consent signed up to the end of the study

Eligibility
Key inclusion criteria
Inclusion criteria:

- Acute ischemic stroke, any territory, with an appropriate neuroradiologic study (head
CT scan or brain MRI scan) providing results consistent with non hemorrhagic stroke

- Onset of symptoms of qualifying stroke within 48 hours prior to randomization. In
patients receiving thrombolytic therapy for the acute stroke, such as tissue-type
plasminogen activator (tPA), administration of study drug may not start until at least
24 hours after completion of thrombolytic therapy

- Significant motor impairment of the leg, as indicated by a NIHSS score =2 on item 6

- Inability to walk without assistance
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Females who are pregnant, breast-feeding, or of childbearing potential and not using
medically acceptable and effective contraception

- Clinical evidence of VTE at screening

- Any evidence of active bleeding on the basis of clinical judgment

- Prior history of intracranial hemorrhage (including that at screening)

- Spinal or epidural analgesia or lumbar puncture within the preceding 24 hours

- Thrombolytic therapy (e.g., tPA) or intra-arterial thrombolytic therapy within the
preceding 24 hours.Thrombolytic therapy is permitted for treatment of the acute stroke
but must have been completed 24 hours prior to randomization.

- Comatose at screening (NIHSS score =2 on item 1a)

- Known or suspected cerebral aneurysm or arteriovenous malformation

- Confirmed malignancy that may pose an increased risk for bleeding or otherwise
compromise follow-up or outcome assessment (e.g., lung cancer)

- Impaired hemostasis, i.e., known or suspected coagulopathy (acquired or inherited);
baseline platelet count <100,000/mm3; aPTT 1.5 X the laboratory upper limit of normal;
or international normalized ratio(INR) >1.5

- Major surgery or recent major trauma within the previous 3 months

- Anticipated need for full-dose treatment with therapeutic levels of an anticoagulant
(LMWH, UFH, oral anticoagulant), e.g., for cardiogenic source of embolism or
dissection

- Treatment with a LMWH or UFH at prophylactic dose for more than 48 hours prior to
randomization(patients receiving LMWH or UFH less than 48 hours prior to randomization
may be randomized)

- Allergy to heparin or enoxaparin sodium, or known hypersensitivity to heparin,
enoxaparin, or pork products

- History of heparin or enoxaparin induced thrombocytopenia and/or thrombosis
(heparin-induced thrombocytopenia [HIT], heparin-associated thrombocytopenia [HAT], or
heparin-induced thrombotic thrombocytopenia syndrome [HITTS])

- History of hypersensitivity to iodinated contrast media and/or iodine

- Bacterial endocarditis

- Prosthetic heart valve

- Known or suspected severe anemia (Hg <10.0 g/dL)

- Uncontrolled arterial hypertension (systolic blood pressure [BP] >180 mmHg or
diastolic BP >100 mmHg) at the time of randomization or clinical hypertensive urgency

- Any other clinically relevant serious diseases, including severe liver disease or
renal failure [creatinine clearance <30 mL/min on at least two occasions].

- Treatment with other investigational agents or devices within the previous 30 days,
planned use of other investigational drugs or devices, or previous enrollment in this
study.

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
Open (masking not 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
1/08/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
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
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Brazil
State/province [3] 0 0
Sao Paulo
Country [4] 0 0
Canada
State/province [4] 0 0
Laval
Country [5] 0 0
Colombia
State/province [5] 0 0
Bogota
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Prague
Country [7] 0 0
India
State/province [7] 0 0
Mumbai
Country [8] 0 0
Israel
State/province [8] 0 0
Natanya
Country [9] 0 0
Italy
State/province [9] 0 0
Milan
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Seoul
Country [11] 0 0
Mexico
State/province [11] 0 0
Mexico
Country [12] 0 0
Poland
State/province [12] 0 0
Warsaw
Country [13] 0 0
South Africa
State/province [13] 0 0
Johannesburg
Country [14] 0 0
Turkey
State/province [14] 0 0
Istanbul

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

Ethics approval
Ethics application status

Summary
Brief summary
Primary objective:

- To demonstrate superiority of enoxaparin 40 mg sc qd in the prevention of VTE compared
to UFH (unfractionated heparin) 5000 U sc q12 hours given for 10 ± 4 days following
acute ischemic stroke.

Secondary objectives:

- To compare the incidence of VTE between the 2 treatment groups at 30, 60, and 90 days
from the time of randomization

- To compare neurologic outcomes between the 2 treatment groups, including incidence of
stroke recurrence, rate of stroke progression, and patient functional status, during the
10 ± 4 days of treatment, and after 30, 60, and 90 days from the time of randomization

- To evaluate the safety of using enoxaparin compared to UFH for VTE prevention in
patients following acute ischemic stroke
Trial website
https://clinicaltrials.gov/ct2/show/NCT00077805
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