Clinical Trial: Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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

Detailed Summary:

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.


Sponsor: Johann Wolfgang Goethe University Hospital

Current Primary Outcome: Difference between INR and CFX correlate >20% [ Time Frame: 0, 1, 2, 3, 6 and 12 month ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Arterial or venous thrombosis [ Time Frame: 12 months ]

Any arterial of venous thrombosis occurring under anticoagulant treatment with vitamin-K antagonists during 1-year follow-up


Original Secondary Outcome: Same as current

Information By: Johann Wolfgang Goethe University Hospital

Dates:
Date Received: August 6, 2012
Date Started: July 2011
Date Completion:
Last Updated: April 14, 2015
Last Verified: April 2015