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

Study Description

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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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Certoparin	Drug: Certoparin; 3000 U anti XA of certoparin in 0.3 ml solution, once daily; Other Names: Sandoparin; Embolex; low molecular weight heparin
Active Comparator: Unfractionated Heparin	Drug: Unfractionated Heparin; solution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily

Outcome Measures

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Primary Outcome Measures :

1. Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism) [ Time Frame: 20 days ]

Secondary Outcome Measures :

1. proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening, [ Time Frame: 20 days ]
2. symptomatic DVT, [ Time Frame: 20 days ]
3. symptomatic non-fatal pulmonary embolism (PE), [ Time Frame: 20 days ]
4. combination of proximal DVT, non fatal PE and death from all causes including PE [ Time Frame: 20 days ]
5. VTE related death, [ Time Frame: 20 days ]

Eligibility Criteria

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Ages Eligible for Study:	70 Years and older (Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

Germany
Novartis investigative sites
Nürnberg, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:	Novartis	Novartis

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Haas S, Schellong SM, Tebbe U, Gerlach HE, Bauersachs R, Melzer N, Abletshauser C, Sieder C, Bramlage P, Riess H. Heparin based prophylaxis to prevent venous thromboembolic events and death in patients with cancer - a subgroup analysis of CERTIFY. BMC Cancer. 2011 Jul 26;11:316. doi: 10.1186/1471-2407-11-316.

Bauersachs R, Schellong SM, Haas S, Tebbe U, Gerlach HE, Abletshauser C, Sieder C, Melzer N, Bramlage P, Riess H. CERTIFY: prophylaxis of venous thromboembolism in patients with severe renal insufficiency. Thromb Haemost. 2011 Jun;105(6):981-8. doi: 10.1160/TH10-09-0614. Epub 2011 Apr 20.

Tebbe U, Schellong SM, Haas S, Gerlach HE, Abletshauser C, Sieder C, Bramlage P, Riess H. Certoparin versus unfractionated heparin to prevent venous thromboembolic events in patients hospitalized because of heart failure: a subgroup analysis of the randomized, controlled CERTIFY study. Am Heart J. 2011 Feb;161(2):322-8. doi: 10.1016/j.ahj.2010.10.005.

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00451412 History of Changes
Other Study ID Numbers:	CMEX839BDE03
First Posted:	March 23, 2007
Last Update Posted:	July 25, 2012
Last Verified:	July 2012

Keywords provided by Novartis:

Venous thromboembolism; Medical patients; Heparin; Low molecular weight heparin	Deep vein thrombosis; Certoparin; Embolism and Thrombosis

Additional relevant MeSH terms:

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