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

Renal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00927602
• Other study ID #: 2008-005234-79
• Status: Terminated
• Phase: Phase 4
• First received: June 24, 2009
• Last updated: April 23, 2012
• Start date: April 2009
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 206
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Medical Patients
• Renal Insufficiency
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• fondaparinux
once daily sc injection, 1,5 mg, max 14 days

Locations

Country	Name	City	State
Italy	University Of Insubria	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major bleeding		up to 48 hours from last injection	Yes
Secondary	symptomatic venous thromboembolism		last treatment dose	No