Acute Ischemic StrokePhase 4NCT00077805
PREVAIL: PREvention of VTE After Acute Ischemic Stroke With LMWH Enoxaparin ( - VTE: Venous Thromboembolism - LMWH: Low Molecular Weight Heparin)
A Phase 4 study testing Enoxaparin sodium in people with Acute Ischemic Stroke, run by Sanofi at 15 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Enoxaparin sodium
- How many people
- Not given
- Where
- 15 sitesin 15 countries
- Study dates
- Aug 2003to Jul 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
15 sites in 15 countries.
15 sites in 15 countries
About this study
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
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.
Read more
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
- Conditions
- Acute Ischemic Stroke
- Being tested
- Enoxaparin sodium
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin sodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative occurrence of VTE events (deep-vein thrombosis, pulmonary embolism)
Measured: 10 ± 4 days following acute ischemic stroke
Secondary outcomes (5)
cumulative VTE events
Measured: at 30-day, 60-day and 90-day
stroke recurrence, stroke progression, National Institute of Health Stroke Scale (NIHSS) scores
Measured: during treatment and follow-up periods
Modified Rankin Scale (MRS) scores
Measured: at 30-day and 90-day follow-up
major & minor hemorrhages
Measured: from the inform consent signed up to the end of the study
Treatment emergent adverse events (TEAE), serious adverse events (SAE), all-cause mortality
Measured: from the inform consent signed up to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2004 (estimated)
- Study startAug 2003
- Primary completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Luc Sagnard, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00077805
- Sponsor's protocol ID
- XRP4563H_4001
- Status last verified
- Jan 2011
- First submitted
- 12 Feb 2004
- Last updated
- 11 Jan 2011
- Results posted
- No
Publications
Kase CS, Albers GW, Bladin C, Fieschi C, Gabbai AA, O'Riordan W, Pineo GF; PREVAIL Investigators. Neurological outcomes in patients with ischemic stroke receiving enoxaparin or heparin for venous thromboembolism prophylaxis: subanalysis of the Prevention of VTE after Acute Ischemic Stroke with LMWH (PREVAIL) study. Stroke. 2009 Nov;40(11):3532-40. doi: 10.1161/STROKEAHA.109.555003. Epub 2009 Aug 20.
PubMed 19696423Sherman DG, Albers GW, Bladin C, Fieschi C, Gabbai AA, Kase CS, O'Riordan W, Pineo GF; PREVAIL Investigators. The efficacy and safety of enoxaparin versus unfractionated heparin for the prevention of venous thromboembolism after acute ischaemic stroke (PREVAIL Study): an open-label randomised comparison. Lancet. 2007 Apr 21;369(9570):1347-1355. doi: 10.1016/S0140-6736(07)60633-3.
PubMed 17448820
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00077805
- Acronym / sponsor ID
- XRP4563H_4001
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Jul 2006 (actual)
- First posted
- 16 Feb 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoxaparin sodium | Drug | – |
Primary outcome
Cumulative occurrence of VTE events (deep-vein thrombosis, pulmonary embolism)
Time frame: 10 ± 4 days following acute ischemic stroke
5 secondary outcomes
cumulative VTE events
Time frame: at 30-day, 60-day and 90-day
stroke recurrence, stroke progression, National Institute of Health Stroke Scale (NIHSS) scores
Time frame: during treatment and follow-up periods
Modified Rankin Scale (MRS) scores
Time frame: at 30-day and 90-day follow-up
major & minor hemorrhages
Time frame: from the inform consent signed up to the end of the study
Treatment emergent adverse events (TEAE), serious adverse events (SAE), all-cause mortality
Time frame: from the inform consent signed up to the end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2011.
- Results publication: PubMed 19696423Kase CS, Albers GW, Bladin C, Fieschi C, Gabbai AA, O'Riordan W, Pineo GF; PREVAIL Investigators. Neurological outcomes in patients with ischemic stroke receiving enoxaparin or heparin for venous thromboembolism prophylaxis: subanalysis of the Prevention of VTE after Acute Ischemic Stroke with LMWH (PREVAIL) study. Stroke. 2009 Nov;40(11):3532-40. doi: 10.1161/STROKEAHA.109.555003. Epub 2009 Aug 20.
- Results publication: PubMed 17448820Sherman DG, Albers GW, Bladin C, Fieschi C, Gabbai AA, Kase CS, O'Riordan W, Pineo GF; PREVAIL Investigators. The efficacy and safety of enoxaparin versus unfractionated heparin for the prevention of venous thromboembolism after acute ischaemic stroke (PREVAIL Study): an open-label randomised comparison. Lancet. 2007 Apr 21;369(9570):1347-1355. doi: 10.1016/S0140-6736(07)60633-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc Sagnard study director
Sanofi
15 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enoxaparin sodium in people with Acute Ischemic Stroke, run by Sanofi at 15 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Australia, Austria, Brazil, Canada and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative occurrence of VTE events (deep-vein thrombosis, pulmonary embolism) (time frame: 10 ± 4 days following acute ischemic stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00077805, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2011.