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Efficacy and Safety of Low-molecular Weight Heparin for Thromboprophylaxis in Acutely Ill Medical Patients

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Embolism

Intervention: Certoparin (Drug); Heparin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

Acutely ill immobilized patients are at a high risk for thromboembolic events including deep venous thrombosis or pulmonary embolism. Unfractionated heparin (UFH) and low molecular weight heparins (LMWH) are thought to be effective in preventing thromboembolic events. This study is designed to provide efficacy and safety data for thromboprophylaxis with the LMWH certoparin in comparison to thromboprophylaxis with UFH in acutely ill non-surgical patients.

Clinical Details

Official title: An Open-label Comparison of the Efficacy and Safety of the Low-molecular-weight Heparin (3000 U Anti-Xa Once Daily) With Unfractionated Heparin for the Prevention of Thromboembolic Complications in Acutely Ill Non-surgical Patients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: The occurrence of thromboembolic events (proximal or distal DVT, PE or VTE related death) during treatment

Secondary outcome:

Thromboembolic events during follow-up period of 3 months

Safety endpoints occurring during the treatment period: Hemorrhage (major or minor), Thrombocytopenia, Symptomatic HIT type II, Induction of HIT-II specific antibodies

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Hospitalization due to an acute non-surgical disease

- Significant decrease in mobility

Exclusion Criteria:

- Indication for anticoagulant or thrombolytic therapy

- Major surgical or invasive procedure within the 4 weeks that precede randomization

- Expected major surgical or invasive procedure (including spinal/peridural/epidural

anesthesia or lumbar puncture) within the 2 weeks that follow the randomization

- Immobilization due to cast or fracture of lower extremity

- Immobilization lasting longer than 3 days in the period prior to randomization

- Heparin administration longer than 36 hours in the period prior to randomization

- Acute ischemic stroke

Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Investigative Centers, Germany

Novartis Pharmaceuticals, Basel, Switzerland

Additional Information

Starting date: February 2006
Last updated: June 7, 2010

Page last updated: August 23, 2015

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