Ignite Creation Date:
2025-12-24 @ 12:54 PM
Ignite Modification Date:
2025-12-30 @ 5:02 PM
Study NCT ID:
NCT01660061
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2012-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome
Sponsor:
Johann Wolfgang Goethe University Hospital
Organization:
Study Overview
Official Title:
Monitoring Anticoagulant Therapy With Vitamin-K Antagonists in Patients With Antiphospholipid Syndrome
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To Assess the Influence of Antiphospholipid Antibodies on INR Test Results in Patients with the Antiphospholipid Syndrome Anticoagulated 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: