Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Birgit Linnemann, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01660061
First received: August 6, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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)

Criteria

Inclusion Criteria:

  • age 18-90 years

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01660061

Contacts
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

Locations
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         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
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:
Syndrome
Antiphospholipid Syndrome
Disease
Pathologic Processes
Autoimmune Diseases
Immune System Diseases
Vitamins
Vitamin K
Anticoagulants
Antibodies, Antiphospholipid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Immunologic Factors

ClinicalTrials.gov processed this record on September 16, 2014