TerminatedPhase 4ACTRN12610000806066

Enoxaparin compared to Warfarin for the treatment of calf vein blood clots

Randomised open label trial assessing the frequency of receiving therapeutic anticoagulant dosing in 6 weeks of enoxaparin treatment compared with 6 weeks of warfarin treatment, for treatment of symptomatic isolated calf vein thrombosis


Sponsor

University of New South Wales

Enrollment

86 participants

Start Date

Jun 18, 2010

Study Type

Interventional

Conditions

Summary

This trial is a research study into an alternative treatment for calf vein blood clots (Deep Vein Thrombosis).The purpose is to investigate whether treatment with Enoxaparin produces better outcomes than standard treatment with Warfarin. We will be looking at how much of the time patients are receiving optimal doses of each of the drugs (therapeutic dose), patient satisfaction with each of the treatments and the costs associated with each of the treatments. The patients who participate in this trial will be ‘randomised’ to receive either; 1. Warfarin treatment group: Patients receive tablets of Warfarin but you will also receive Enoxaparin (fine needle injections) for the first few days while their body adjusts to Warfarin. The dose of Warfarin needs to be customised for each patient. This is done with blood tests called INR tests every few days to start with and then once per week or once per fortnight depending how your body responds to the warfarin. This is standard treatment and will probably be managed by their general practitioner (GP). 2. Enoxaparin group: patients assigned to the Enoxaparin group will receive daily injections with a very fine needle into the skin of their abdomen or legs. Most patients will be able to learn to give themselves these injections. Alternatively we could teach a friend or relative to give them to the patient, or in some cases we may be able to provide someone to come to their house to give them the injections. We think that treatment of symptomatic calf Deep Vein Thrombosis with enoxaparin may result in a higher chance of receiving therapeutic treatment (resulting from their being less variability in how patients bodies respond to be drug), a higher level patient satisfaction due to the decreased number of doctors visits, blood tests and dietary restrictions, and lower costs to the health care system than treatment with warfarin.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 100 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares two blood-thinning treatments for calf vein blood clots: enoxaparin injections versus warfarin pills. Adults 18 and older with a confirmed blood clot in the lower leg veins who do not have a clot higher up or in the lungs may participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

At least 6 weeks with subcutaneous enoxaparin only, dosage 1.5mg/kg daily. Duration of treatment will be determined by the treating physician in accordance with American College of Chest Physicians (A

At least 6 weeks with subcutaneous enoxaparin only, dosage 1.5mg/kg daily. Duration of treatment will be determined by the treating physician in accordance with American College of Chest Physicians (ACCP) and National Health and Medical Research Council (NHMRC) Guidelines with consideration of individual patient clinical profile and risk factors and the results of follow up ultrasound. Most patients will receive treatment for three months.


Locations(1)

Australia

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ACTRN12610000806066