Enoxaparin 20mg Versus 30mg Subcutaneously Once Daily in Elderly Patients With Impaired Renal Function

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.

Study Overview

• Status: Completed
• Conditions: Renal Impairment; Venous Thromboembolism
• Intervention / Treatment: Drug: Enoxaparin 20Mg/0.2mL Prefilled Syringe; Drug: Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • LAU Medical Center-Rizk Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Enoxaparin 20 mg	Drug: Enoxaparin 20Mg/0.2mL Prefilled Syringe; Enoxaparin 20mg subcutaneously once daily
ACTIVE_COMPARATOR: Enoxaparin 30 mg	Drug: Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml; Enoxaparin 30mg subcutaneously once daily. Half of the graduated 60Mg/0.6Ml Inj Syringe is administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak anti-Xa levels	Peak anti-Xa levels, drawn 4 hours after the enoxaparin dose is given	Day 3 of thromboprophylaxis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trough anti-xa levels	Trough anti-Xa levels, drawn right before the third enoxaparin dose is given	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).	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).	Venous thromboembolism (VTE) within 30 days will be assessed from randomization till date of VTE or date of discharge, whichever comes first.

Collaborators and Investigators

• Sponsor: Lebanese American University
• Investigators: Principal Investigator: Nibal R Chamoun, PharmD, Lebanese American University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 24, 2015
• Primary Completion (ACTUAL): July 13, 2017
• Study Completion (ACTUAL): July 13, 2017

Study Registration Dates

• First Submitted: April 9, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (ACTUAL): May 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 8, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Elderly; Anticoagulation; Prevention; Low molecular weight heparin; Enoxaparin; Thromboprophylaxis; Anti-Xa levels
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Embolism and Thrombosis; Renal Insufficiency; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin; Enoxaparin sodium
• Other Study ID Numbers: LAU.SOP.NC1.25/Jun/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No