Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Antiphospholipid Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT01660061

EV 77/11

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18-90 years

Exclusion criteria

• none

Trial design

150 participants in 2 patient groups

APS patients

Description:

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

Controls

Description:

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