Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome
- Conditions
- Antiphospholipid Syndrome
- Registration Number
- NCT01660061
- Lead Sponsor
- Johann Wolfgang Goethe University Hospital
- 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 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- age 18-90 years
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference between INR and CFX correlate >20% 0, 1, 2, 3, 6 and 12 month
- Secondary Outcome Measures
Name Time Method Arterial or venous thrombosis 12 months Any arterial of venous thrombosis occurring under anticoagulant treatment with vitamin-K antagonists during 1-year follow-up
Trial Locations
- Locations (1)
Goethe University Hospital
🇩🇪Frankfurt/Main, Hessen, Germany