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

Novartis

Status and phase: Completed; Phase 3

Conditions: Thromboembolism

Treatments: Drug: Unfractionated Heparin; Drug: Certoparin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00451412

CMEX839BDE03

Details and patient eligibility

About

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

Enrollment: 3,254 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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3,254 participants in 2 patient groups

Certoparin

Experimental group

Treatment:

Drug: Certoparin

Unfractionated Heparin

Active Comparator group

Treatment:

Drug: Unfractionated Heparin