A Comparison of Certoparin and Unfractionated Heparin in the Prevention of Thromboembolic Events in Acutely Ill Medical Patients
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Thromboembolism
Intervention: Certoparin (Drug); Unfractionated Heparin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis
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.
Clinical Details
Official title: A Randomized, Double-blind, Multi-center Comparison of the Efficacy and Safety of Certoparin (3000 U Anti-Xa o.d.) With Unfractionated Heparin (5000 IU t.i.d.) in the Prophylaxis of Thromboembolic Events in Acutely Ill Medical Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism)
Secondary outcome: proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening,symptomatic DVT, symptomatic non-fatal pulmonary embolism (PE), combination of proximal DVT, non fatal PE and death from all causes including PE VTE related death,
Eligibility
Minimum age: 70 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Novartis investigative sites, Nürnberg, Germany
Additional Information
Starting date: January 2007
Last updated: July 24, 2012
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