Enoxaparin in Acute Venous Thromboembolic Disease

The Efficacy of Subcutaneous Enoxaparin Once Daily in the Treatment of Acute Venous Thromboembolic Disease: an Open-labelled, Non-comparative, Multicentric, Phase IV Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00265993

Enrollment

251

Registered

2005-12-15

Start date

2004-12-31

Completion date

2009-01-31

Last updated

2010-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thrombosis

Brief summary

Study objectives : * To evaluate the efficacy/safety profile of enoxaparin once a day treatment in acute venous thromboembolic disease.

Interventions

DRUGenoxaparin

* All patients will be treated with enoxaparin 1.5 mg/kg, once a day, subcutaneously for up to 10 days. * Long-term oral anticoagulation will be started in all patients after 24 hours of initiation of enoxaparin treatment and continued at least for 3 months.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with symptomatic lower-extremity deep venous thrombosis confirmed by doppler USG (ultrasonography), with or without confirmed symptomatic pulmonary embolism associated with provoked risk factors

Exclusion criteria

* Patients with a history of heparin or warfarin treatment longer than 24 hours, * Patients requiring thrombolytic treatment, * Patients having thrombophilia diagnosis, * Patients with prior deep vein thrombosis or pulmonary emboli evidence, * Patients with familial bleeding disorder, * Patients who are at any known bleeding risk, such as active bleeding, active ulcerative bowel disease, angiodysplasia and having oculary, spinal or central nervous system surgery within the last month * Patients with renal failure (serum creatinine concentration \> 180 mmol/L or \> 2.03 mg/dL), * Patients with severe hepatic failure * Patients with history of allergy against heparin and protamine, * Patients with history of thrombocytopenia associated with heparin administration or of skin necrosis after heparin or warfarin treatment, * Patients participating in another clinical study within the last 4 months * Patients who are pregnant The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Design outcomes

Primary

Measure	Time frame
Frequency of bleeding emerged during the study drug administration; Frequency of bleeding emerged during 3 months of monitorization when the patient is on oral anticoagulants.	3 months

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026