NCT01660061

Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Antiphospholipid Syndrome

Timeline

• Start date: 2011-07-01
• Primary completion: 2014-06-01
• Completion: 2014-12-01
• First posted: 2012-08-08
• Last updated: 2015-04-15

Locations

1 site across 1 country: Germany