Apixaban Validation Study - Additional Study on Fresh Samples
NCT ID: NCT03073265
Last Updated: 2018-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
109 participants
OBSERVATIONAL
2017-05-08
2017-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The results will be used to complete results obtained previously on frozen samples.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Validation of Rivaroxaban Assay for US Registration
NCT02333929
A First-in-human Trial to Assess the Safety and Performance of the BioCaptis in Healthy Volunteers
NCT05813041
A Study to Compare Analytes in Blood Collected Using an Investigational Collection Device With a Commercial Predicate
NCT01786408
Tbit System Precision and Correlation of Different Blood Samples
NCT04478812
Clinical Performance Evaluation of Native Whole Blood Samples of Patients on DOACs With the Perosphere ClotChek™
NCT07012291
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients on apixaban
Patients currently on apixaban who meet inclusion/exclusion criteria A blood draw will be done on each patient to measure apixaban concentration in plasma using anti-Xa assay and LCMS.
STA-Apixaban Calibrator & Control
Measurement of apixaban level will be done using anti-Xa assay (IVD).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
STA-Apixaban Calibrator & Control
Measurement of apixaban level will be done using anti-Xa assay (IVD).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Weight ≤ 60 kg,
* Haematocrit below normal values as determined by local laboratory or \< 40% for male and \< 37% for female
* Renal impairment documented (creatinine clearance ≤ 80 mL/min as per Cockcroft -Gault equation) or serum creatinine ≥ 1.5 mg/dL
* Co-medication with aspirin or any other NSAIDs (nonsteroidal anti-inflammatory drugs)
* Co-medication with anti-platelet agents
Exclusion Criteria
* Patients under other anti-coagulant treatment
* Samples that are not collected, stored, or handled in accordance with sample collection procedures defined above.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Diagnostica Stago
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Moses Cone Memorial Hospital
Greensboro, North Carolina, United States
Lehigh Valley Health Nrwork
Allentown, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VSP A006 - US_comp / 1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.