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Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome

This study has been completed.
Information provided by (Responsible Party):
Birgit Linnemann, Johann Wolfgang Goethe University Hospitals Identifier:
First received: August 6, 2012
Last updated: April 14, 2015
Last verified: April 2015
To Assess the Influence of Antiphospholipid Antibodies on INR Test Results in Patients with the Antiphospholipid Syndrome Anticoagulated with Vitamin-K Antagonists.

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

Resource links provided by NLM:

Further study details as provided by Birgit Linnemann, Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Difference between INR and CFX correlate >20% [ Time Frame: 0, 1, 2, 3, 6 and 12 month ]

Secondary Outcome Measures:
  • Arterial or venous thrombosis [ Time Frame: 12 months ]
    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
Study Completion Date: December 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
APS patients
Patients with antiphospholipid syndrome requiring long-term anticoagulant therapy with vitamin-K antagonists
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.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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:

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Please refer to this study by its identifier: NCT01660061

Goethe University Hospital
Frankfurt/Main, Hessen, Germany, D-60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Principal Investigator: Birgit Linnemann, MD Goethe University Hospital, Division of Vascular Medicine
  More Information

Additional Information:
Responsible Party: Birgit Linnemann, Priv.-Doz. Dr. Birgit Linnemann, Johann Wolfgang Goethe University Hospitals Identifier: NCT01660061     History of Changes
Other Study ID Numbers: EV 77/11
Study First Received: August 6, 2012
Last Updated: April 14, 2015

Keywords provided by Birgit Linnemann, Johann Wolfgang Goethe University Hospitals:
Antiphospholipid syndrome
Antiphospholipid antibodies
Vitamin-K antagonists
International normalized ratio
Chromogenic factor X

Additional relevant MeSH terms:
Antiphospholipid Syndrome
Pathologic Processes
Autoimmune Diseases
Immune System Diseases
Vitamin K
Antibodies, Antiphospholipid
Growth Substances
Physiological Effects of Drugs
Immunologic Factors
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Coagulants processed this record on May 25, 2017