Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT02586818
Eligibility Criteria:
Inclusion Criteria - All
* The subjects must be \> 18 years of age.
* The subjects must be willing and competent to sign an informed consent.
* The subjects must be able to attend the clinic for one visit to donate one FS blood sample and one venous blood draw of approximately 10 cc.
Exclusion Criteria - All
* The subject is unable to donate fingerstick and venous blood samples.
* The subject has a history of clinically significant bleeding associated with incising the finger and/or the venipuncture.
* The subject is enrolled in any other study that involves an investigational drug and/or device.
Additional Inclusion Criteria - Therapeutic Group
* The subject must require oral VKA anticoagulant therapy.
* The patient must have been anticoagulated for at least three months prior to enrollment.
Additional Exclusion Criteria - Normal Group
\- Subjects receiving any form of anticoagulation drugs such as Aspirin or Clopidogrel.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02586818
Study Brief:
Protocol Section:
NCT02586818