An observational study in Antiphospholipid Syndrome, sponsored by Johann Wolfgang Goethe University Hospital. Completed at 1 site in Germany. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-04-15.
Sponsored by Johann Wolfgang Goethe University Hospital · Observational
To Assess the Influence of Antiphospholipid Antibodies on INR Test Results in Patients with the Antiphospholipid Syndrome Anticoagulated with Vitamin-K Antagonists.
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.
121 studies on the registry are indexed under Antiphospholipid Syndrome; 51 are open to participants now.
This study's planned enrollment of 150 is below the median of 181 across 52 observational studies indexed under Antiphospholipid Syndrome.
Browse Antiphospholipid Syndrome studies →Johann Wolfgang Goethe University Hospital is the lead sponsor of 158 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with antiphospholipid syndrome requiring long-term treatment with vitamin-K antagonists (N=40) Pateints without antiphospholipid antibodies treated with vitamin-K antagonists (N=100)
Exclusion Criteria:
Patients with antiphospholipid syndrome requiring long-term anticoagulant therapy with vitamin-K antagonists
Patients without antiphospholipid antibodies requiring anticoagulant therapy with vitamin-K antagonists
Difference between INR and CFX correlate >20%
Time frame: 0, 1, 2, 3, 6 and 12 month
Arterial or venous thrombosis
Any arterial of venous thrombosis occurring under anticoagulant treatment with vitamin-K antagonists during 1-year follow-up
Time frame: 12 months
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Johann Wolfgang Goethe University Hospital