Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome
To Assess the Influence of Antiphospholipid Antibodies on INR Test Results in Patients with the Antiphospholipid Syndrome Anticoagulated with Vitamin-K Antagonists.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Monitoring Anticoagulant Therapy With Vitamin-K Antagonists in Patients With Antiphospholipid Syndrome|
- Difference between INR and CFX correlate >20% [ Time Frame: 0, 1, 2, 3, 6 and 12 month ] [ Designated as safety issue: No ]
- Arterial or venous thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]Any arterial of venous thrombosis occurring under anticoagulant treatment with vitamin-K antagonists during 1-year follow-up
Biospecimen Retention: Samples Without DNA
|Study Start Date:||July 2011|
|Study Completion Date:||December 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Patients with antiphospholipid syndrome requiring long-term anticoagulant therapy with vitamin-K antagonists
Patients without antiphospholipid antibodies requiring anticoagulant therapy 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01660061
|Goethe University Hospital|
|Frankfurt/Main, Hessen, Germany, D-60590|
|Principal Investigator:||Birgit Linnemann, MD||Goethe University Hospital, Division of Vascular Medicine|