Acute IllnessPhase 4LIFENOXNCT00622648
Study to Evaluate the Mortality Reduction of Enoxaparin in Hospitalized Acutely Ill Medical Receiving Enoxaparin
A Phase 4 study testing Enoxaparin in people with Acute Illness, run by Sanofi at 9 sites in 9 countries.
Trial summary
The primary objective: To demonstrate in patients hospitalized for an acute medical illness that enoxaparin with Graduated Elastic Stockings is superior to enoxaparin-placebo with Graduated Elastic Stockings on overall mortality at day 30 after randomization. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Acute Illness
- What is being tested?
- Enoxaparin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8,329 participants
- Where
- 9 sitesin 9 countries
- Study dates
- Jan 2008to Dec 2010
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalization within 48 hours prior randomization for at least one of the following medical acute medical illness:
- Acute decompensation of heart failure
- Severe systemic infection and at least one of the following:
- Chronic pulmonary diseases (COPD, pulmonary fibrosis, pulmonary restrictive syndrome…)
- Obesity (BMI ≥ 30kg/m2)
- Personal history of VTE
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- Age ≥ 60 years
- Active cancer (defined as being histologically confirmed with an initial diagnosis or recurrence or metastasis within the past 6 months) excluding planned hospitalization for chemotherapy
- Anticipated duration of hospitalization at least 6 days
- Health status:
- ASA Health status score ≤ 3 (American Society of Anesthesiologists)
- ECOG ≤ 2 in cancer patient
- Anticipated life expectancy > 1 week
Who cannot join
- Major surgery or major trauma within the previous 6 weeks (orthopedic or trauma surgery to the lower extremities, gastrointestinal tract, urological, chest, gynecological surgery)
- Need for any ventilatory support (with intubation required)
- Symptomatic VTE at enrollment
- Multi organ failure
- Evidence of an active bleeding disorder
- Contraindication to anticoagulation:
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- Coagulopathy (acquired or inherited)
- Neurosurgery within the past day 30
- History of cerebral hemorrhage at any time
- Known bacterial endocarditis
- Uncontrolled arterial hypertension (systolic BP > 200 mmHg or diastolic BP > 110 mm Hg) at 2 successive readings
- Haemostatic abnormalities: baseline platelet count <50,000/mm3, activated partial thromboplastin time (aPTT) 1.5x the upper limit of normal, or International Normalized Ratio (INR) > 1.5
- Indication for thrombolytic therapy
- Need for a curative treatment of anticoagulant therapy (low molecular weight heparin, unfractionated heparin, oral anticoagulant therapy)
- Receiving LMWH or UFH at prophylactic doses for more than 72 hours prior to inclusion (patients receiving LMWH or UFH at prophylactic doses for 72 hours or less prior to entry may be included in the study)
- Oral anticoagulant therapy within 72 hours prior to inclusion
- Cerebrovascular accident at inclusion and within 10 days prior study inclusion
- Prosthetic heart valves
- Confirmed cerebral metastases
- Known hypersensitivity to heparin or LMWH, or pork-derived products
- History of documented episode of heparin, or LMWH induced thrombocytopenia, and/or thrombosis (HIT, HAT, or HITTS)
- Participating in another clinical trial within the previous 30 days (patients with cancer included in a cancer treatment protocol are authorized to participate)
- Persistent renal failure (defined as a documented value of calculated creatinine clearance < 30 mL/min on at least 2 occasions ³3 days prior to entry into the study)
- Known or suspected severe anemia of unexplained cause considered clinically relevant by investigator
- Spinal or epidural analgesia or lumbar puncture within the preceding 24 hours
- Unlikely to be compliant (e.g. alcohol, drug abuse)
- Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling to be tested for pregnancy (pregnancy status should be checked by serum or urine pregnancy testing prior to exposure to the investigational product)
- Refusal or inability to give informed consent to participate in the study
- Inability to be followed-up after discharge until day 90 after randomization
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
9 sites in 9 countries.
9 sites in 9 countries
About this study
Official title: International, Multi-center, Randomized, Double Blind Study to Compare the Overall Mortality in Acutely Ill Medical Patients Treated With Enoxaparin Versus Placebo in Addition to Graduated Elastic Stockings
The primary objective:
- To demonstrate in patients hospitalized for an acute medical illness that enoxaparin with Graduated Elastic Stockings is superior to enoxaparin-placebo with Graduated Elastic Stockings on overall mortality at day 30 after randomization.
Read more
The secondary objective:
- To compare, in patients hospitalized for an acute medical illness, enoxaparin with Graduated Elastic Stockings versus enoxaparin placebo with Graduated Elastic Stockings on overall mortality at day 90 after randomization.
- To evaluate the safety of enoxaparin VTE prophylaxis in patients hospitalized for acute medical illness with respect to major hemorrhage, total bleedings, heparin induced thrombocytopenia, adverse events and serious adverse events .
- Conditions
- Acute Illness
- Being tested
- Enoxaparin, Placebo
- Keywords
- Medical prevention therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
40 mg once daily for 6 to 14 days (10 ± 4 days)
PlaceboDrug
Enoxaparin placebo 40mg once daily for 6 to 14 days (10 ± 4 days)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Enoxaparin: 40 mg once daily for 6 to 14 days (10 ± 4 days) Receives: Drug: Enoxaparin |
| B | Placebo comparator | Enoxaparin placebo 40mg once daily for 6 to 14 days (10 ± 4 days) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death rate with all causes mortality
Measured: At day 30
Hemorrhages
Measured: Occuring until day 90
Secondary outcomes (2)
All-cause mortality
Measured: Between randomization and day 90
Adverse events, serious adverse events
Measured: During the entire observation period (from informed consent signature until Day 90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute IllnessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8,329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bruno DESLANDES, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622648
- Sponsor's protocol ID
- ENOXA_C_01249
- Acronym
- LIFENOX
- Status last verified
- Dec 2010
- First submitted
- 14 Feb 2008
- Last updated
- 28 Dec 2010
- Results posted
- No
Publications
Kakkar AK, Cimminiello C, Goldhaber SZ, Parakh R, Wang C, Bergmann JF; LIFENOX Investigators. Low-molecular-weight heparin and mortality in acutely ill medical patients. N Engl J Med. 2011 Dec 29;365(26):2463-72. doi: 10.1056/NEJMoa1111288.
PubMed 22204723
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multi-center, Randomized, Double Blind Study to Compare the Overall Mortality in Acutely Ill Medical Patients Treated With Enoxaparin Versus Placebo in Addition to Graduated Elastic Stockings
- ClinicalTrials.gov ID
- NCT00622648
- Acronym / sponsor ID
- LIFENOX / ENOXA_C_01249
- Conditions
- Acute Illness
- Keywords
- Medical prevention therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,329 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 Feb 2008 (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.
The primary objective:
- To demonstrate in patients hospitalized for an acute medical illness that enoxaparin with Graduated Elastic Stockings is superior to enoxaparin-placebo with Graduated Elastic Stockings on overall mortality at day 30 after randomization.
The secondary objective:
- To compare, in patients hospitalized for an acute medical illness, enoxaparin with Graduated Elastic Stockings versus enoxaparin placebo with Graduated Elastic Stockings on overall mortality at day 90 after randomization.
- To evaluate the safety of enoxaparin VTE prophylaxis in patients hospitalized for acute medical illness with respect to major hemorrhage, total bleedings, heparin induced thrombocytopenia, adverse events and serious adverse events .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: EnoxaparinEnoxaparin: 40 mg once daily for 6 to 14 days (10 ± 4 days) |
| B | Placebo comparator | Drug: PlaceboEnoxaparin placebo 40mg once daily for 6 to 14 days (10 ± 4 days) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Hospitalization within 48 hours prior randomization for at least one of the following medical acute medical illness:
- Anticipated duration of hospitalization at least 6 days
- Health status:
- Anticipated life expectancy > 1 week
Key exclusion criteria (30 listed)
- Major surgery or major trauma within the previous 6 weeks (orthopedic or trauma surgery to the lower extremities, gastrointestinal tract, urological, chest, gynecological surgery)
- Need for any ventilatory support (with intubation required)
- Symptomatic VTE at enrollment
- Multi organ failure
- Evidence of an active bleeding disorder
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 |
|---|---|---|
| Enoxaparin40 mg once daily for 6 to 14 days (10 ± 4 days) | Drug | A |
| PlaceboEnoxaparin placebo 40mg once daily for 6 to 14 days (10 ± 4 days) | Drug | B |
Primary outcome
Death rate with all causes mortality
Time frame: At day 30
Hemorrhages
Time frame: Occuring until day 90
2 secondary outcomes
All-cause mortality
Time frame: Between randomization and day 90
Adverse events, serious adverse events
Time frame: During the entire observation period (from informed consent signature until Day 90)
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 28 Dec 2010.
- Derived from this study: PubMed 22204723Kakkar AK, Cimminiello C, Goldhaber SZ, Parakh R, Wang C, Bergmann JF; LIFENOX Investigators. Low-molecular-weight heparin and mortality in acutely ill medical patients. N Engl J Med. 2011 Dec 29;365(26):2463-72. doi: 10.1056/NEJMoa1111288.
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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.
Bruno DESLANDES study director
Sanofi
9 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enoxaparin in people with Acute Illness, run by Sanofi at 9 sites in 9 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 13 inclusion and 30 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 28 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Brazil, China, Hong Kong, India, Malaysia and 4 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. Some participants in this study may receive a placebo. 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?
Death rate with all causes mortality (time frame: At day 30). The study lists 2 primary outcomes in all. 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 NCT00622648, which also lists 1 linked publication.
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 28 Dec 2010; AzTrials last refreshed its copy on 7 Nov 2026.