Efficacy and Safety of Low-Molecular Weight Heparin for Thromboprophylaxis in Acutely Ill Medical Patients - Full Text View

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00311753

Purpose

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.

Condition	Intervention	Phase
Embolism	Drug: Certoparin Drug: Heparin	Phase III

MedlinePlus related topics: Blood Thinners

Drug Information available for: Heparin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Novartis:

Primary Outcome Measures:

Incidence of blood clots in the veins during the treatment period. [ Time Frame: 10 ± 2 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of major bleeding, blood clots deep in arms or legs, blood clots that break off and lodge in the lung, and death related to blood clots during the treatment period and during 3 month follow up [ Time Frame: 90 days (± 7 days) after the end of the treatment ] [ Designated as safety issue: Yes ]

Enrollment:	342
Study Start Date:	February 2006
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Certoparin	Drug: Certoparin Low-molecular-weight heparin, Certoparin (3000 U anti-Xa once daily) treatment period of 10 ± 2 days
2: Active Comparator Heparin	Drug: Heparin 7500 IU of unfractionated heparin administered twice daily during the treatment period of 10 ± 2 days

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311753

Locations

Germany

Investigative Centers, Germany
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CMEX839BDE02
Study First Received:	April 4, 2006
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00311753 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

heparin, thromboprophylaxis, medical patients, acutely ill
Acutely ill non surgical patients
Immobilization

Study placed in the following topic categories:

Anticoagulants
Heparin, Low-Molecular-Weight
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Thrombosis
Calcium heparin

Body Weight
Calcium, Dietary
Embolism and Thrombosis
Fibrin Modulating Agents
Embolism
Heparin
Certoparin

Additional relevant MeSH terms:

Anticoagulants
Molecular Mechanisms of Pharmacological Action
Heparin, Low-Molecular-Weight
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

Calcium heparin
Embolism and Thrombosis
Fibrin Modulating Agents
Embolism
Therapeutic Uses
Cardiovascular Diseases
Heparin
Certoparin

ClinicalTrials.gov processed this record on May 07, 2009