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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-24

Study Completion Date

2017-07-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Venous Thromboembolism Renal Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Enoxaparin 20 mg

Group Type ACTIVE_COMPARATOR

Enoxaparin 20Mg/0.2mL Prefilled Syringe

Intervention Type DRUG

Enoxaparin 20mg subcutaneously once daily

Enoxaparin 30 mg

Group Type ACTIVE_COMPARATOR

Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml

Intervention Type DRUG

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

Interventions

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Enoxaparin 20Mg/0.2mL Prefilled Syringe

Enoxaparin 20mg subcutaneously once daily

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No