Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome

NCT ID: NCT01660061

Last Updated: 2015-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Antiphospholipid Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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APS patients

Patients with antiphospholipid syndrome requiring long-term anticoagulant therapy with vitamin-K antagonists

No interventions assigned to this group

Controls

Patients without antiphospholipid antibodies requiring anticoagulant therapy with vitamin-K antagonists

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age 18-90 years

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Birgit Linnemann

Priv.-Doz. Dr. Birgit Linnemann

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Birgit Linnemann, MD

Role: PRINCIPAL_INVESTIGATOR

Goethe University Hospital, Division of Vascular Medicine

Locations

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Goethe University Hospital

Frankfurt am Main, Hesse, Germany

Site Status

Countries

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Germany

Related Links

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http://www.gefaesszentrum-frankfurt.de/forschung.php

Click here for more information about this study: Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome

Other Identifiers

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EV 77/11

Identifier Type: -

Identifier Source: org_study_id

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