A Study of Pharmacogenomics Testing in Patients Who Experience Bleeding While on Apixaban or Warfarin
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 17-007645
Sponsor Protocol Number: 17-007645
About this study
The purpose of htis study is to see if PGx testing will help to determine better ways for doctors to use apixaban treatment.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Subjects must be > 18 years of age who are on ongoing treatment with apixaban with one or more of the following criteria will be included:
- A condition that would require long term anticoagulation with one of the DOAC such as recurrent venous thromboembolic disease or atrial fibrillation plus one of the points below.
- Recent GI bleeding while on apixaban therapy.
- Prior history of bleeding with warfarin.
Exclusion Criteria:
- Pregnant patients
- Renal impairment (GFR less than 50 mg/dl)
- Contraindication for apixaban use
- Mentally incapable of signing a consent form
- Patients with history of valvular heart disease
- Patients with known anti-phospholipid syndrome
- Patients with active malignancy
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Fadi Shamoun, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available