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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00311753

Collaborator

(none)

342

Enrollment

Locations

Arms

171

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Embolism	Drug: Certoparin Drug: Heparin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

342 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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 Start Date :

Feb 1, 2006

Actual Primary Completion Date :

Dec 1, 2007

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Certoparin

Drug: Certoparin

Low-molecular-weight heparin, Certoparin (3000 U anti-Xa once daily) treatment period of 10 ± 2 days

Active Comparator: 2

Heparin

Drug: Heparin

7500 IU of unfractionated heparin administered twice daily during the treatment period of 10 ± 2 days

Outcome Measures

Primary Outcome Measures

The occurrence of thromboembolic events (proximal or distal DVT, PE or VTE related death) during treatment [10 ± 2 days]

Secondary Outcome Measures

Thromboembolic events during follow-up period of 3 months [90 days (± 7 days) after the end of the treatment]
Safety endpoints occurring during the treatment period: Hemorrhage (major or minor), Thrombocytopenia, Symptomatic HIT type II, Induction of HIT-II specific antibodies [10 ± 2 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

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