Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome

Antiphospholipid Syndrome Clinical Trial

Official title:

Monitoring Anticoagulant Therapy With Vitamin-K Antagonists in Patients With Antiphospholipid Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660061
• Other study ID #: EV 77/11
• Status: Completed
• Phase: N/A
• First received: August 6, 2012
• Last updated: April 14, 2015
• Start date: July 2011
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

To Assess the Influence of Antiphospholipid Antibodies on INR Test Results in Patients with the Antiphospholipid Syndrome Anticoagulated with Vitamin-K Antagonists.

Description:

Patients with an antiphospholipid syndrome receiving Vitamin-K antagonists for secondary prevention after a first thrombotic complication are known to be at higher risk of recurrent thrombotic events despite INR values in the therapeutic range. It ist also known that antiphospholipid antibodies can interfere with phospholipid-dependent tests (e.g. prothrombin time and INR).

The primary objective of this study is to determine the prevalence of interfering antiphospholipid antibodies. The intensity of anticoagulant therapy was assessed by measuring the INR using different thromboplastins and the CoaguChek system for INR self-assessment. Test results were compared to measurements of the phospholipid-independent chromogenic factor X.

The second objective of this study is to evaluate the incidence of recurrent thrombotic events during 1-year follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• age 18-90 years

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Antiphospholipid Syndrome
• Syndrome

Locations

Country	Name	City	State
Germany	Goethe University Hospital	Frankfurt/Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between INR and CFX correlate >20%		0, 1, 2, 3, 6 and 12 month	No
Secondary	Arterial or venous thrombosis	Any arterial of venous thrombosis occurring under anticoagulant treatment with vitamin-K antagonists during 1-year follow-up	12 months	No