NCT01660061

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

2.9 years

First QC Date

August 6, 2012

Last Update Submit

April 14, 2015

Conditions

Antiphospholipid Syndrome

Keywords

Antiphospholipid syndromeAntiphospholipid antibodiesVitamin-K antagonistsInternational normalized ratioChromogenic factor X

Outcome Measures

Primary Outcomes (1)

  • Difference between INR and CFX correlate >20%

    0, 1, 2, 3, 6 and 12 month

Secondary Outcomes (1)

  • Arterial or venous thrombosis

    12 months

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • age 18-90 years

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goethe University Hospital

Frankfurt am Main, Hesse, D-60590, Germany

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples.

MeSH Terms

Conditions

Antiphospholipid Syndrome

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System Diseases

Study Officials

  • Birgit Linnemann, MD

    Goethe University Hospital, Division of Vascular Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priv.-Doz. Dr. Birgit Linnemann

Study Record Dates

First Submitted

August 6, 2012

First Posted

August 8, 2012

Study Start

July 1, 2011

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

DE(1)