Association Between Genetic Variant Scores and Warfarin Effect



Status:Recruiting
Conditions:Atrial Fibrillation, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:4/3/2019
Start Date:February 11, 2019
End Date:March 12, 2021
Contact:Elijah Yi, BS
Email:elijah.yi@cipherome.com
Phone:(408) 243-1460

Use our guide to learn which trials are right for you!

Association Between Risk Scores for Genetic Variants and Percentage of Time in Therapeutic Range for Patients With Atrial Fibrillation, Deep Vein Thrombosis, and/or Intracardiac Thrombosis Taking Warfarin

Study objective is to determine whether there is an association between genetic variant risk
scores and clinical outcomes (percent time in therapeutic range, time to reach therapeutic
international normalized ratio (INR), INR ≥ 4, major bleeding event, ischemic stroke, death)
in patients taking warfarin for atrial fibrillation, deep vein thrombosis (DVT), and/or
intracardiac thrombosis.

It is anticipated that next generation genomic sequencing will identify rare genetic variants
in ethnically diverse patient populations, which otherwise would not have been detected using
commercially available warfarin tests. Furthermore, retrospective review of clinical outcomes
(percent time in therapeutic range, time to reach therapeutic international normalized ratio
(INR), INR ≥ 4, major bleeding event, ischemic stroke) of study enrollees will determine the
clinical utility of genetic variant risk scores. Study outcomes will provide guidance on
future directions for optimizing dosing algorithms for warfarin that combine pharmacogenetic
principles with clinical dosing.

Inclusion Criteria:

1. Patients with non-valvular atrial fibrillation

2. Patients with deep venous thrombosis (DVT) with no hypercoagulable condition

3. Patients with non-valvular atrial fibrillation and DVT (with no hypercoagulable
condition)

4. Patients with intracardiac thrombosis (i.e. apical thrombosis, atrial thrombosis,
auricular thrombosis, mural thrombosis, and/or ventricular thrombosis)

5. Age 18-80 years

6. Signed informed consent

Exclusion Criteria:

1. Presence of a mechanical heart valve

2. Failure to provide signed informed consent

3. Known diseases that affects coagulation test results such as vitamin K deficiency,
disseminated intravascular coagulopathy, Von Willebrand disease, hemophilia, liver
failure, etc.

4. Taking any medication or on diet that affects coagulation test results such as:

Amiodarone, Anabolic Steroids, Fluconazole, Ketoconazole, Itraconazole, Aspirin and
Salicylates, Cephalosporins, Chloral Hydrate, Cimetidine, Clofibrate, Cranberry Juice,
Danazol, Diflunisal, Disulfiram, Fluvoxamine, Ginkgo Biloba, Heparin, Isoniazid (INH),
Erythromycin, Clarithromycin, Metronidazole, NSAIDS, Omeprazole, Paroxetine Pepto-Bismol,
Tamoxifen, Tetracycline, Ciprofloxacin, Levofloxacin, Moxifloxacin, Levothyroxine,
Ticlopidine, Trimethoprim-Sulfamethoxazole, Vitamin E, Barbiturates, Carbamazepine, Oral
contraceptives, Rifampin, Vitamin K, American Ginseng, Allopurinol, Corticosteroids
(Prednisone), Penicillin, Phenytoin
We found this trial at
1
site
Santa Clara, California 95138
Phone: 408-885-5000
?
mi
from
Santa Clara, CA
Click here to add this to my saved trials