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Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome

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ClinicalTrials.gov Identifier: NCT01660061
Recruitment Status : Completed
First Posted : August 8, 2012
Last Update Posted : April 15, 2015
Information provided by (Responsible Party):
Birgit Linnemann, Johann Wolfgang Goethe University Hospitals

Brief Summary:
To Assess the Influence of Antiphospholipid Antibodies on INR Test Results in Patients with the Antiphospholipid Syndrome Anticoagulated with Vitamin-K Antagonists.

Condition or disease
Antiphospholipid Syndrome

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.

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring Anticoagulant Therapy With Vitamin-K Antagonists in Patients With Antiphospholipid Syndrome
Study Start Date : July 2011
Primary Completion Date : June 2014
Study Completion Date : December 2014

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

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

Secondary Outcome Measures :
  1. 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.

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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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Posted: August 8, 2012    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 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
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors