Lina Petrella

CONTACT

Lead Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Patient is taking (or will imminently start taking) an oral Xa inhibitor (e.g., apixaban, edoxaban, rivaroxaban) for: stroke prevention in atrial fibrillation, treatment or secondary prevention of deep venous thrombosis or pulmonary embolism, prevention of VTE in patients who have undergone elective total hip or total knee replacement surgery provided there are 30 or more days of planned treatment remaining at the time of enrolment.

•Active bleeding as determine by the site investigator after discussion with the treating team (patient may remain eligible for up to 120 hours from platform entry if condition is resolved and antithrombotic therapy is resumed)
•Anticipated major cardiac surgery, neurosurgery, or spine surgery within the next 3 days
•Known pregnancy (with testing available for women with childbearing potential)
•Known use of dabigatran within last month
•Allergy to dabigatran
•Concomitant use of amiodarone, ketoconazole, rifampin, verapamil, clopidogrel, prasugrel, or ticagrelor
•eGFR \< 30mL/minute calculated by Cockcroft-Gault equation using adjusted weight \[patient may remain eligible for up to 120 hours from platform entry if acute kidney injury is resolved such that antithrombotic therapy can be safely resumed/prescribed\]
•Off label use (e.g., metallic mechanical heart valve, left ventricular thrombus, antiphospholipid antibody syndrome)