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PREVAIL: PREvention of VTE After Acute Ischemic Stroke With LMWH Enoxaparin ( - VTE: Venous Thromboembolism - LMWH: Low Molecular Weight Heparin)

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Ischemic Stroke

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 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

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Cumulative occurrence of VTE events (deep-vein thrombosis, pulmonary embolism)

Secondary outcome:

cumulative VTE events

stroke recurrence, stroke progression, National Institute of Health Stroke Scale (NIHSS) scores

Modified Rankin Scale (MRS) scores

major & minor hemorrhages

Treatment emergent adverse events (TEAE), serious adverse events (SAE), all-cause mortality

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

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.

Locations and Contacts

Sanofi-Aventis, North Ryde, Australia

Sanofi-Aventis, Vienna, Austria

Sanofi-Aventis, Sao Paulo, Brazil

Sanofi-Aventis, Laval, Canada

Sanofi-Aventis, Bogota, Colombia

Sanofi-Aventis, Prague, Czech Republic

Sanofi-Aventis, Mumbai, India

Sanofi-Aventis, Natanya, Israel

Sanofi-Aventis, Milan, Italy

Sanofi-Aventis, Seoul, Korea, Republic of

Sanofi-Aventis, Mexico, Mexico

Sanofi-Aventis, Warsaw, Poland

Sanofi-Aventis, Johannesburg, South Africa

Sanofi-Aventis, Istanbul, Turkey

Sanofi-Aventis, Bridgewater, New Jersey, United States

Additional Information

Starting date: August 2003
Last updated: January 10, 2011

Page last updated: August 23, 2015

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