Last updated: December 11, 2023
Sponsor: Dosentrx Ltd.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Thromboembolism
Treatment
Standard of Care
ReX-C intervention
Clinical Study ID
NCT03424330
RXC-154-2017-CLE
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or Female, at least 18 years of age
- Subject is able to swallow pills and use ReX-C device to receive medication.
- Subject is able to read and understand the Informed Consent Form.
- Subject receives anti-coagulants for the treatment and prevention of thromboembolismevents, (e.g: Arterial Fibrillation (AF), Deep Vein Thrombosis (DVT) or PulmonaryEmbolism (PE)).
- Subject receives Novel Oral Anti-coagulant (NOAC); including; Pradaxa® (dabigatran),Xarelto® (rivaroxaban) and Eliquis® (apixaban).
- Subject is recruited at least 1 month after treatment initiation and has stabledose regime.
- Subject receives stable dose of medication for at least a month.
- Subject takes medication therapy at home.
Exclusion
Exclusion Criteria: 1. Subject has significant physical disability including; poor fine motor skills,impaired visual or auditory faculties, mental disorders or other impairment affectingability to provide Informed Consent Form or use the ReX-C dispensing unit effectively. 2. Subject cen not use ReX-C to receive medications. 3. Subject is participating in another clinical study that does not permit participationin two studies simultaneously. 4. Subject is at end stage or terminal illness with anticipated life expectancy of 6months or less.
Study Design
Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Standard of Care
Phase:
Study Start date:
January 09, 2019
Estimated Completion Date:
December 25, 2023
Study Description
Connect with a study center
Carmel Medical Center
Haifa, 3436212
IsraelActive - Recruiting
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