Medical Prevention TherapyRECOVERYNCT01133002
Canadian Outpatient VTE Management Registry
An observational study of Medical Prevention Therapy, run by Sanofi at 1 site in Canada.
Trial summary
Primary Objective: To obtain prospective, clinical practice-based data on how symptomatic VTE is managed with low molecular weight heparin (LMWH) enoxaparin in Canadian outpatient settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Prevention Therapy
- Type of treatment
- Pill or oral medicine
- How many people
- 915 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2007to Jun 2010
- Phase
- Observational
- 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
Study population: Patients with objectively confirmed symptomatic VTE treated at approximately 15 outpatient clinics across Canada which use enoxaparin for the treatment of acute VTE.
Who may be able to join
- Objectively confirmed VTE
- Initiation of enoxaparin treatment within Day 0-10 after diagnosis of VTE:
- Outpatients who will be treated with enoxaparin + VKA in combination are permitted to receive initial treatment other than enoxaparin for a maximum of 48 hours or 2 treatment doses preceding entry into the study
- Outpatients on enoxaparin monotherapy are permitted to receive up to 10 days of treatment other than enoxaparin preceding entry into the study.
Who cannot join
- Medical or psychiatric disorders associated with altered cognition or mentation that precludes understanding of the informed consent process.
- 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
1 site in 1 country.
About this study
Official title: National, Prospective, Observational, Cohort Study of Venous Thromboembolism (VTE) Management With the Low Molecular Weight Heparin, Enoxaparin, in the Outpatient Setting in Canada
Primary Objective:
- To obtain prospective, clinical practice-based data on how symptomatic VTE is managed with low molecular weight heparin (LMWH) enoxaparin in Canadian outpatient settings.
Read more
Secondary Objective:
- To describe the demographic and clinical characteristics of patients with symptomatic VTE including characteristics of VTE, VTE risk factors and bleeding risk factors.
- To assess the frequency of patient characteristics that would necessitate adjustment in the dose or duration of enoxaparin therapy, e.g. high BMI, impaired creatinine clearance, advanced age, cancer-associated VTE.
- To assess the degree of adherence in clinical practice to Consensus Guidelines (ACCP/American College of chest Physician 2008) for the management of acute VTE, vis a vis:
- Appropriate dosing of enoxaparin
- Recommended duration of initial LMWH therapy
- Adequate overlap of LMWH with vitamin K antagonists (VKA)
- Recommended duration of longterm VKA
- Frequency of use of LMWH monotherapy to treat cancer-related VTE
- To access safety outcomes (including bleeding and recurrent VTE)
- To describe the utilization of resources due to bleeding and recurrent VTE during the treatment period.
- Conditions
- Medical Prevention Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VTE management registry | Patients receiving enoxaparin, with or without oral anticoagulation, within Day 0-10 after diagnosis of VTE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Deep Venous Thrombosis (DVT) and/or Pulmonary Embolism (PE) and/or thrombosis at unusual sites
Measured: Day 180 or end of anticoagulant therapy whichever comes first
Number of patients prescribed twice daily (BID) vs. once daily (QD) enoxaparin
Measured: Day 180 or end of anticoagulant therapy whichever comes first
Proportion of patients who used short (5-7 days) vs. longer use (more than 7 days) durations of treatment with enoxaparin
Measured: Day 180 or end of anticoagulant therapy whichever comes first
Percentage of exnoxaparin prefilled syringes vs. multidose vials used during treatment
Measured: Day 180 or end of anticoagulant therapy whichever comes first
Secondary outcomes (4)
Patient characteristics associated with different patterns of VTE management and enoxaparin use
Analysis of patient characteristics associated with different patterns of VTE management and enoxaparin use, such as age, weight, creatinine clearance, co-morbid disease, VTE characteristics, concomitant use of other pharmacological and non-pharmacological treatment of the VTE, concomitant use of other non-VTE related therapies
Measured: Day 180 or end of anticoagulant therapy whichever comes first
Percentage of cases managed as recommended by Concensus Guidelines (ACCP 2008)
Measured: Day 180 or end of anticoagulant therapy whichever comes first
Incidence of bleeding events and episodes of recurrent VTE
Measured: Day 180 or end of anticoagulant therapy whichever comes first
To tabulate VTE-related resources utilized during the study period and compare resource utilization in patients treated vs not treated as per Concensus Guidelines (ACCP 2008)
VTE-related resources utilized during the study period, including cost of VTE and its treatment (e.g. duration of hospital stay, drug costs, costs related to bleeding such as transfusions, costs of recurrent VTE) and compare resource utilization in patients treated vs. not treated as recommended by Concensus Guidelines (ACCP 2008)
Measured: Day 180 or end of anticoagulant therapy whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startAug 2007
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Prevention TherapyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 915 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Affairs, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133002
- Sponsor's protocol ID
- ENOXA_L_02260
- Acronym
- RECOVERY
- Status last verified
- Aug 2010
- First submitted
- 26 May 2010
- Last updated
- 31 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Prospective, Observational, Cohort Study of Venous Thromboembolism (VTE) Management With the Low Molecular Weight Heparin, Enoxaparin, in the Outpatient Setting in Canada
- ClinicalTrials.gov ID
- NCT01133002
- Acronym / sponsor ID
- RECOVERY / ENOXA_L_02260
- Conditions
- Medical Prevention Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 915 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 28 May 2010 (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 obtain prospective, clinical practice-based data on how symptomatic VTE is managed with low molecular weight heparin (LMWH) enoxaparin in Canadian outpatient settings.
Secondary Objective:
- To describe the demographic and clinical characteristics of patients with symptomatic VTE including characteristics of VTE, VTE risk factors and bleeding risk factors.
- To assess the frequency of patient characteristics that would necessitate adjustment in the dose or duration of enoxaparin therapy, e.g. high BMI, impaired creatinine clearance, advanced age, cancer-associated VTE.
- To assess the degree of adherence in clinical practice to Consensus Guidelines (ACCP/American College of chest Physician 2008) for the management of acute VTE, vis a vis:
- Appropriate dosing of enoxaparin
- Recommended duration of initial LMWH therapy
- Adequate overlap of LMWH with vitamin K antagonists (VKA)
- Recommended duration of longterm VKA
- Frequency of use of LMWH monotherapy to treat cancer-related VTE
- To access safety outcomes (including bleeding and recurrent VTE)
- To describe the utilization of resources due to bleeding and recurrent VTE during the treatment period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VTE management registry | – | –Patients receiving enoxaparin, with or without oral anticoagulation, within Day 0-10 after diagnosis of VTE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with objectively confirmed symptomatic VTE treated at approximately 15 outpatient clinics across Canada which use enoxaparin for the treatment of acute VTE.
Key inclusion criteria (4 listed)
- Objectively confirmed VTE
- Initiation of enoxaparin treatment within Day 0-10 after diagnosis of VTE:
- Outpatients who will be treated with enoxaparin + VKA in combination are permitted to receive initial treatment other than enoxaparin for a maximum of 48 hours or 2 treatment doses preceding entry into the study
- Outpatients on enoxaparin monotherapy are permitted to receive up to 10 days of treatment other than enoxaparin preceding entry into the study.
Key exclusion criteria (2 listed)
- Medical or psychiatric disorders associated with altered cognition or mentation that precludes understanding of the informed consent process.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with Deep Venous Thrombosis (DVT) and/or Pulmonary Embolism (PE) and/or thrombosis at unusual sites
Time frame: Day 180 or end of anticoagulant therapy whichever comes first
Number of patients prescribed twice daily (BID) vs. once daily (QD) enoxaparin
Time frame: Day 180 or end of anticoagulant therapy whichever comes first
Proportion of patients who used short (5-7 days) vs. longer use (more than 7 days) durations of treatment with enoxaparin
Time frame: Day 180 or end of anticoagulant therapy whichever comes first
Percentage of exnoxaparin prefilled syringes vs. multidose vials used during treatment
Time frame: Day 180 or end of anticoagulant therapy whichever comes first
4 secondary outcomes
Patient characteristics associated with different patterns of VTE management and enoxaparin use
Time frame: Day 180 or end of anticoagulant therapy whichever comes first
Percentage of cases managed as recommended by Concensus Guidelines (ACCP 2008)
Time frame: Day 180 or end of anticoagulant therapy whichever comes first
Incidence of bleeding events and episodes of recurrent VTE
Time frame: Day 180 or end of anticoagulant therapy whichever comes first
To tabulate VTE-related resources utilized during the study period and compare resource utilization in patients treated vs not treated as per Concensus Guidelines (ACCP 2008)
Time frame: Day 180 or end of anticoagulant therapy whichever comes first
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 31 Aug 2010.
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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.
Medical Affairs study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Prevention Therapy, run by Sanofi at 1 site in Canada.
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 2 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 31 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
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?
Proportion of patients with Deep Venous Thrombosis (DVT) and/or Pulmonary Embolism (PE) and/or thrombosis at unusual sites (time frame: Day 180 or end of anticoagulant therapy whichever comes first). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2010.