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Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism (VTE) in Medical Patients With Renal Insufficiency

Information source: Università degli Studi dell'Insubria
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Medical Patients; Renal Insufficiency

Intervention: fondaparinux (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Università degli Studi dell'Insubria

Official(s) and/or principal investigator(s):
Walter Ageno, MD, Study Chair, Affiliation: Università degli Studi dell'Insubria
Francesco Dentali, MD, Study Director, Affiliation: Università degli Studi dell'Insubria
Alessandro Squizzato, MD, Principal Investigator, Affiliation: Università degli Studi dell'Insubria

Summary

Fondaparinux is a parenteral anticoagulant drug and is approved for the prevention of venous thromboembolism in high risk medical patients. A relevant proportion of medical patients have moderate to severe renal insufficiency, which is an independent risk factor for bleeding. This risk may be further increased when low molecular weight heparin or fondaparinux are administered in patients with severe renal insufficiency, defined by a creatinine clearance of lower than 30 mL/min. No clear indications are available to reduce such risk in patients who require thromboprophylaxis. A lower dose of fondaparinux, 1. 5 mg daily, has been recently approved for the prevention of venous thromboembolism in the specific population of patients with a creatinine clearance between 20 and 50 mL/min (European Marketing Authorization). However, there are to our knowledge no clinical studies that have assessed the safety and efficacy of this reduced dosage in medical patients.

Clinical Details

Official title: The Safety and Efficacy of Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism in Medical Patients With Renal Insufficiency

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: major bleeding

Secondary outcome: symptomatic venous thromboembolism

Eligibility

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age > 60 years

- Acute medical disease requiring thromboprophylaxis according to international

guidelines

- Anticipated immobilization of at least 4 days

- Renal insufficiency defined by creatinine clearance between 20 and 50 mL/min

according the MDRD formula

- Written informed consent

Exclusion Criteria:

- Active bleeding or bleeding in the previous 3 months

- Known bleeding diathesis

- Platelet count < 100. 000

- Ongoing treatment with unfractionated heparin, low molecular weight heparin,

fondaparinux, or vitamin K antagonists

- Use of prophylactic doses of heparin, low molecular weight heparin, or fondaparinux

in the previous 72 hours

- Life expectancy < 1 month

Locations and Contacts

University Of Insubria, Varese 21100, Italy
Additional Information

Related publications:

Cohen AT, Davidson BL, Gallus AS, Lassen MR, Prins MH, Tomkowski W, Turpie AG, Egberts JF, Lensing AW; ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ. 2006 Feb 11;332(7537):325-9. Epub 2006 Jan 26.

Lim W, Dentali F, Eikelboom JW, Crowther MA. Meta-analysis: low-molecular-weight heparin and bleeding in patients with severe renal insufficiency. Ann Intern Med. 2006 May 2;144(9):673-84.

Starting date: April 2009
Last updated: April 23, 2012

Page last updated: August 20, 2015

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