Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome
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Purpose
To Assess the Influence of Antiphospholipid Antibodies on INR Test Results in Patients with the Antiphospholipid Syndrome Anticoagulated with Vitamin-K Antagonists.
| Condition |
|---|
|
Antiphospholipid Syndrome |
| Study Type: | Observational |
| 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
Plasma samples.
| Estimated Enrollment: | 150 |
| Study Start Date: | July 2011 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
APS patients
Patients with antiphospholipid syndrome requiring long-term anticoagulant therapy with vitamin-K antagonists
|
|
Controls
Patients without antiphospholipid antibodies requiring anticoagulant therapy 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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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)
Inclusion Criteria:
- age 18-90 years
Exclusion Criteria:
- none
Contacts and Locations| Contact: Birgit Linnemann, MD | +49 (0)69 6301 ext 6096 | Birgit.Linnemann@kgu.de |
| Contact: Edelgard Lindhoff-Last, MD | +49 (0)69 6301 ext 5096 | lindhoff-last@em.uni-frankfurt.de |
| Germany | |
| Goethe University Hospital | Recruiting |
| Frankfurt/Main, Hessen, Germany, D-60590 | |
| Contact: Birgit Linnemann, MD +49 (0)69 6301 ext 6096 Birgit.Linnemann@kgu.de | |
| Contact: Edelgard Lindhoff-Last, MD +49 (0)69 6301 ext 5096 lindhoff-last@em.uni-frankfurt.de | |
| Principal Investigator: Birgit Linnemann, MD | |
| Principal Investigator: | Birgit Linnemann, MD | Goethe University Hospital, Division of Vascular Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Birgit Linnemann, Priv.-Doz. Dr. Birgit Linnemann, Johann Wolfgang Goethe University Hospitals |
| ClinicalTrials.gov Identifier: | NCT01660061 History of Changes |
| Other Study ID Numbers: | EV 77/11 |
| Study First Received: | August 6, 2012 |
| Last Updated: | August 6, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Johann Wolfgang Goethe University Hospitals:
|
Antiphospholipid syndrome Antiphospholipid antibodies Vitamin-K antagonists International normalized ratio Chromogenic factor X |
Additional relevant MeSH terms:
|
Antiphospholipid Syndrome Autoimmune Diseases Immune System Diseases Anticoagulants Vitamin K Vitamins Antibodies, Antiphospholipid Hematologic Agents Therapeutic Uses Pharmacologic Actions |
Micronutrients Growth Substances Physiological Effects of Drugs Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants Immunologic Factors |
ClinicalTrials.gov processed this record on June 18, 2013