Venous ThromboembolismPhase 4NCT03158792
Enoxaparin 20mg Versus 30mg Subcutaneously Once Daily in Elderly Patients With Impaired Renal Function
A Phase 4 study testing Enoxaparin 20Mg/0.2mL Prefilled Syringe and Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml in people with Venous Thromboembolism and Renal Impairment, run by Lebanese American University at 1 site in Lebanon.
Trial summary
This is a clinical trial including non-surgical patients, 70 years of age or older, with renal impairment requiring pharmacological venous thromboembolism prevention during hospitalization. Patients are randomized to receive either 20 mg or 30mg of enoxaparin. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Venous Thromboembolism, Renal Impairment
- What is being tested?
- Enoxaparin 20Mg/0.2mL Prefilled Syringe and Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteLebanon
- Study dates
- 24 Oct 2015to 13 Jul 2017
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Non-surgical patients
- 70 years of age or older
- With renal impairment (creatinine clearance ≤35ml/min)
- Requiring pharmacological thromboprophylaxis
Who cannot join
- Indication for a treatment dose of anticoagulant treatment
- Knee surgery or hip surgery within 10 to 35 days, respectively
- Surgery, trauma, hemodialysis, peritoneal dialysis, or bleeding
- History of heparin-induced thrombocytopenia
- Known or suspected hypersensitivity to any component of study drug
- Patients with an excessive risk of bleeding and not eligible for pharmacological thromboprophylaxis based on physician assessment or due to any of the 3 major risk factors including active gastroduodenal ulcer, bleeding within the past three months prior to hospital admission, or a platelet count of <50,000 platelets/ mm3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Non-Surgical Venous Thromboembolism Prophylaxis Dosing Strategies: Enoxaparin 20mg Versus 30mg Subcutaneously Once Daily in Elderly Patients With Impaired Renal Function
This is a clinical trial including non-surgical patients, 70 years of age or older, with renal impairment requiring pharmacological venous thromboembolism prevention during hospitalization. Patients are randomized to receive either 20 mg or 30mg of enoxaparin. Both dosing regimens of enoxaparin have been approved for thromboprophylaxis in impaired kidney function in different countries. Therefore, this study aims to evaluate the efficacy and safety of enoxaparin 20mg versus 30mg subcutaneously daily by comparing anti-xa levels, thrombosis and bleeding events.
- Conditions
- Venous Thromboembolism, Renal Impairment
- Being tested
- Enoxaparin 20Mg/0.2mL Prefilled Syringe, Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml
- Keywords
- Anticoagulation, Thromboprophylaxis, Anti-Xa levels, Elderly, Prevention, Enoxaparin, Low molecular weight heparin
- Medical subject headings
- Venous Thromboembolism, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin 20Mg/0.2mL Prefilled SyringeDrug
Enoxaparin 20mg subcutaneously once daily
Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6MlDrug
Enoxaparin 30mg subcutaneously once daily. Half of the graduated 60Mg/0.6Ml Inj Syringe is administered
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin 20 mg | Active comparator | Not described Receives: Drug: Enoxaparin 20Mg/0.2mL Prefilled Syringe |
| Enoxaparin 30 mg | Active comparator | Not described Receives: Drug: Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak anti-Xa levels
Peak anti-Xa levels, drawn 4 hours after the enoxaparin dose is given
Measured: Day 3 of thromboprophylaxis
Secondary outcomes (3)
Trough anti-xa levels
Trough anti-Xa levels, drawn right before the third enoxaparin dose is given
Measured: Day 3 of thromboprophylaxis
Bleeding according to the GUSTO bleeding criteria.
Measured: Bleeding within 30 days will be assessed from randomization till date of bleeding or date of discharge, whichever comes first.
Objectively confirmed symptomatic or asymptomatic venous thromboembolism (VTE) including both deep vein thrombosis (DVT) and or pulmonary embolism (PE).
Chart documentation of objectively detected DVT by either bilateral venography or duplex ultrasonography whereas PE detection by contrast enhanced computerized tomography scan (CT Scan) or Magnetic resonance imaging (MRI).
Measured: Venous thromboembolism (VTE) within 30 days will be assessed from randomization till date of VTE or date of discharge, 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 posted18 May 2017
- Study start24 Oct 2015
- Primary completion13 Jul 2017
- Study completion13 Jul 2017
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 Venous ThromboembolismStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lebanese American University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nibal Chamoun, Lebanese American University
- Investigators
- Nibal R Chamoun, PharmD, Principal investigator, Lebanese American University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158792
- Sponsor's protocol ID
- LAU.SOP.NC1.25/Jun/2015
- Status last verified
- Sep 2017
- First submitted
- 9 Apr 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chamoun N, Ghanem H, Hachem A, Hariri E, Lteif C, Mansour H, Dimassi H, Zalloum R, Ghanem G. Evaluation of prophylactic dosages of Enoxaparin in non-surgical elderly patients with renal impairment. BMC Pharmacol Toxicol. 2019 May 7;20(1):27. doi: 10.1186/s40360-019-0308-8.
PubMed 31064405
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non-Surgical Venous Thromboembolism Prophylaxis Dosing Strategies: Enoxaparin 20mg Versus 30mg Subcutaneously Once Daily in Elderly Patients With Impaired Renal Function
- ClinicalTrials.gov ID
- NCT03158792
- Acronym / sponsor ID
- LAU.SOP.NC1.25/Jun/2015
- Conditions
- Venous Thromboembolism, Renal Impairment
- Keywords
- Anticoagulation, Thromboprophylaxis, Anti-Xa levels, Elderly, Prevention, Enoxaparin, Low molecular weight heparin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Lebanese American UniversityUniversity, hospital or other
- Study start
- 24 Oct 2015 (actual)
- Primary completion
- 13 Jul 2017 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 18 May 2017 (actual)
- 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.
This is a clinical trial including non-surgical patients, 70 years of age or older, with renal impairment requiring pharmacological venous thromboembolism prevention during hospitalization. Patients are randomized to receive either 20 mg or 30mg of enoxaparin. Both dosing regimens of enoxaparin have been approved for thromboprophylaxis in impaired kidney function in different countries. Therefore, this study aims to evaluate the efficacy and safety of enoxaparin 20mg versus 30mg subcutaneously daily by comparing anti-xa levels, thrombosis and bleeding events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enoxaparin 20 mg | Active comparator | Drug: Enoxaparin 20Mg/0.2mL Prefilled Syringe |
| Enoxaparin 30 mg | Active comparator | Drug: Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Non-surgical patients
- 70 years of age or older
- With renal impairment (creatinine clearance ≤35ml/min)
- Requiring pharmacological thromboprophylaxis
Key exclusion criteria (6 listed)
- Indication for a treatment dose of anticoagulant treatment
- Knee surgery or hip surgery within 10 to 35 days, respectively
- Surgery, trauma, hemodialysis, peritoneal dialysis, or bleeding
- History of heparin-induced thrombocytopenia
- Known or suspected hypersensitivity to any component of study drug
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 20Mg/0.2mL Prefilled SyringeEnoxaparin 20mg subcutaneously once daily | Drug | Enoxaparin 20 mg |
| Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6MlEnoxaparin 30mg subcutaneously once daily. Half of the graduated 60Mg/0.6Ml Inj Syringe is administered | Drug | Enoxaparin 30 mg |
Primary outcome
Peak anti-Xa levels
Time frame: Day 3 of thromboprophylaxis
Peak anti-Xa levels, drawn 4 hours after the enoxaparin dose is given
3 secondary outcomes
Trough anti-xa levels
Time frame: Day 3 of thromboprophylaxis
Bleeding according to the GUSTO bleeding criteria.
Time frame: Bleeding within 30 days will be assessed from randomization till date of bleeding or date of discharge, whichever comes first.
Objectively confirmed symptomatic or asymptomatic venous thromboembolism (VTE) including both deep vein thrombosis (DVT) and or pulmonary embolism (PE).
Time frame: Venous thromboembolism (VTE) within 30 days will be assessed from randomization till date of VTE or date of discharge, 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 11 Sep 2017.
- Derived from this study: PubMed 31064405Chamoun N, Ghanem H, Hachem A, Hariri E, Lteif C, Mansour H, Dimassi H, Zalloum R, Ghanem G. Evaluation of prophylactic dosages of Enoxaparin in non-surgical elderly patients with renal impairment. BMC Pharmacol Toxicol. 2019 May 7;20(1):27. doi: 10.1186/s40360-019-0308-8.
- Individual participant dataSharing planned: No
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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.
Nibal R Chamoun, PharmD principal investigator
Lebanese American University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enoxaparin 20Mg/0.2mL Prefilled Syringe and Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml in people with Venous Thromboembolism and Renal Impairment, run by Lebanese American University at 1 site in Lebanon.
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 6 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 Sep 2017. 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 Lebanon. 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?
Peak anti-Xa levels (time frame: Day 3 of thromboprophylaxis). 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 NCT03158792, 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 11 Sep 2017.