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

Phase 3

Completed

• Conditions: Embolism
• Interventions: Drug: Certoparin; Drug: Heparin

• Registration Number: NCT00311753
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-04-04
• Study First Submitted QC: 2006-04-04
• Study First Posted: 2006-04-06
• Primary Completion: 2007-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 342

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Certoparin	Certoparin
2	Heparin	Heparin

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Thromboembolic events during follow-up period of 3 months	90 days (± 7 days) after the end of the treatment

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇨🇭 Basel, Switzerland