A Comparison of Certoparin and Unfractionated Heparin in the Prevention of Thromboembolic Events in Acutely Ill Medical Patients
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| ClinicalTrials.gov Identifier: NCT00451412 |
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Recruitment Status :
Completed
First Posted : March 23, 2007
Last Update Posted : July 25, 2012
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Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Thromboembolism | Drug: Certoparin Drug: Unfractionated Heparin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 3254 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| 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 Start Date : | January 2007 |
| Actual Primary Completion Date : | June 2009 |
| Actual Study Completion Date : | June 2009 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Blood Thinners
| Arm | Intervention/treatment |
|---|---|
| Experimental: Certoparin |
Drug: Certoparin
3000 U anti XA of certoparin in 0.3 ml solution, once daily
Other Names:
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| Active Comparator: Unfractionated Heparin |
Drug: Unfractionated Heparin
solution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily |
Primary Outcome Measures :
- Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism) [ Time Frame: 20 days ]
Secondary Outcome Measures :
- proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening, [ Time Frame: 20 days ]
- symptomatic DVT, [ Time Frame: 20 days ]
- symptomatic non-fatal pulmonary embolism (PE), [ Time Frame: 20 days ]
- combination of proximal DVT, non fatal PE and death from all causes including PE [ Time Frame: 20 days ]
- VTE related death, [ Time Frame: 20 days ]
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| Ages Eligible for Study: | 70 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Hospitalized medical patients 70 years of age or older
- Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances)
- written informed consent
Exclusion Criteria:
- immobilization longer than 3 days prior to randomization
- prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system
- expected major surgical or invasive procedure within the next 3 weeks after randomization
- LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization
- immobilization due to cast or fracture
- indication for anticoagulatory or thrombolytic therapy
- acute symptomatic DVT / PE
- known hypersensitivity to any of the study drugs or drugs with similar chemical structures
- Acute or history of heparin induced thrombocytopenia type II (HIT II)
Other protocol-defined inclusion/exclusion criteria may apply
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00451412
Locations
| Germany | |
| Novartis investigative sites | |
| Nürnberg, Germany | |
Sponsors and Collaborators
Novartis
Investigators
| Study Director: | Novartis | Novartis |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00451412 History of Changes |
| Other Study ID Numbers: |
CMEX839BDE03 |
| First Posted: | March 23, 2007 Key Record Dates |
| Last Update Posted: | July 25, 2012 |
| Last Verified: | July 2012 |
Keywords provided by Novartis:
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Venous thromboembolism Medical patients Heparin Low molecular weight heparin |
Deep vein thrombosis Certoparin Embolism and Thrombosis |
Additional relevant MeSH terms:
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Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Calcium heparin Certoparin Heparin |
Heparin, Low-Molecular-Weight Dalteparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |