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 eventsstroke 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
|