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

Purpose

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	Intervention	Phase
Thromboembolism	Drug: Certoparin Drug: Unfractionated Heparin	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Blood Clots Blood Thinners

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism) [ Time Frame: 20 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening, [ Time Frame: 20 days ] [ Designated as safety issue: No ]
symptomatic DVT, [ Time Frame: 20 days ] [ Designated as safety issue: No ]
symptomatic non-fatal pulmonary embolism (PE), [ Time Frame: 20 days ] [ Designated as safety issue: No ]
combination of proximal DVT, non fatal PE and death from all causes including PE [ Time Frame: 20 days ] [ Designated as safety issue: No ]
VTE related death, [ Time Frame: 20 days ] [ Designated as safety issue: No ]


Enrollment:	3254
Study Start Date:	January 2007
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	70 Years and older (Senior)
Genders Eligible for Study:	Both
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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451412

Locations


Germany
Novartis investigative sites
Nürnberg, Germany

Sponsors and Collaborators

Novartis

Investigators


Study Director:	Novartis	Novartis

More Information

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
Study First Received:	March 21, 2007
Last Updated:	July 24, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Romania: National Medicines Agency

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

ClinicalTrials.gov processed this record on September 27, 2016