NCT03158792

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2017

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

1.7 years

First QC Date

April 9, 2017

Last Update Submit

September 8, 2017

Conditions

Venous ThromboembolismRenal Impairment

Keywords

AnticoagulationThromboprophylaxisAnti-Xa levelsElderlyPreventionEnoxaparinLow molecular weight heparin

Outcome Measures

Primary Outcomes (1)

  • Peak anti-Xa levels

    Peak anti-Xa levels, drawn 4 hours after the enoxaparin dose is given

    Day 3 of thromboprophylaxis

Secondary Outcomes (3)

  • Trough anti-xa levels

    Day 3 of thromboprophylaxis

  • Bleeding according to the GUSTO bleeding criteria.

    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).

    Venous thromboembolism (VTE) within 30 days will be assessed from randomization till date of VTE or date of discharge, whichever comes first.

Study Arms (2)

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

Interventions

Enoxaparin 20Mg/0.2mL Prefilled SyringeDRUG

Enoxaparin 20mg subcutaneously once daily

Enoxaparin 20 mg
Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6MlDRUG

Enoxaparin 30mg subcutaneously once daily. Half of the graduated 60Mg/0.6Ml Inj Syringe is administered

Enoxaparin 30 mg

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Non-surgical patients
  • years of age or older
  • With renal impairment (creatinine clearance ≤35ml/min)
  • Requiring pharmacological thromboprophylaxis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LAU Medical Center-Rizk Hospital

Beirut, Lebanon

Location

Related Publications (1)

  • 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.

    PMID: 31064405DERIVED

MeSH Terms

Conditions

Venous ThromboembolismRenal Insufficiency

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Nibal R Chamoun, PharmD

    Lebanese American University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor of Pharmacy Practice and Clinical Coordinator

Study Record Dates

First Submitted

April 9, 2017

First Posted

May 18, 2017

Study Start

October 24, 2015

Primary Completion

July 13, 2017

Study Completion

July 13, 2017

Last Updated

September 11, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

LE(1)