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Completed

NCT Number: NCT01660061

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.

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Key information

Conditions

Antiphospholipid Syndrome Autoimmune Diseases Immune System Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Goethe University Hospital

Frankfurt am Main, Hesse, D-60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18-90 years

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. Difference between INR and CFX correlate >20%

    Time frame: 0, 1, 2, 3, 6 and 12 month

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

Monitoring Anticoagulant Therapy With Vitamin-K Antagonists in Patients With Antiphospholipid Syndrome

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 8, 2012
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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