A Comparison of Certoparin and Unfractionated Heparin in the Prevention of Thromboembolic Events in Acutely Ill Medical Patients

Phase 3

Completed

• Conditions: Thromboembolism
• Interventions: Drug: Certoparin; Drug: Unfractionated Heparin

• Registration Number: NCT00451412
• Lead Sponsor: Novartis

Brief Summary

This study is designed to provide efficacy and safety data for certoparin in the prophylaxis of venous thromboembolism in immobilized, acutely ill medical patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-03-21
• Study First Submitted QC: 2007-03-22
• Study First Posted: 2007-03-23
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-24
• Last Update Posted: 2012-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3254

Inclusion Criteria

1. Hospitalized medical patients 70 years of age or older
2. Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances)
3. written informed consent

Exclusion Criteria

1. immobilization longer than 3 days prior to randomization
2. prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system
3. expected major surgical or invasive procedure within the next 3 weeks after randomization
4. LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization
5. immobilization due to cast or fracture
6. indication for anticoagulatory or thrombolytic therapy
7. acute symptomatic DVT / PE
8. known hypersensitivity to any of the study drugs or drugs with similar chemical structures
9. Acute or history of heparin induced thrombocytopenia type II (HIT II)

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Certoparin	Certoparin	-
Unfractionated Heparin	Unfractionated Heparin	-

Primary Outcome Measures

Name	Time	Method
Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism)	20 days

Secondary Outcome Measures

Name	Time	Method
proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening,	20 days
symptomatic DVT,	20 days
symptomatic non-fatal pulmonary embolism (PE),	20 days
combination of proximal DVT, non fatal PE and death from all causes including PE	20 days
VTE related death,	20 days

Trial Locations

Locations (1)

Novartis investigative sites; 🇩🇪 Nürnberg, Germany