Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZuyderland Medisch Centrum
About this trial
A prospective, multicenter, 1:1 randomized, investigator initiated study. Goal of this study is to examine the safety of uninterrupted periprocedural DOAC use.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged >18 years using DOAC and undergoing elective ICA or PCI.
Provided signed informed consent
Disqualifiers
Patients initially presenting with Acute Coronary Syndrome (STEMI, NSTEMI, UA)
Patients <18 years old
Calculated creatinine clearance <30 mL/min
Patients simultaneously participating in another clinical trial
Trial design
Design model
Parallel
Treatments tested in this trial
Uninterrupted DOAC use
Other interventionContinuing DOAC use in advance of elective ICA or PCI.
Interrupted DOAC use
Other interventionUsual care, interruption of DOAC prior to procedure.
Treatment groups
1,270 Participants
are divided into 2 treatment groupsGroup A: Interrupted DOAC use (group 1)Active comparator 1 intervention
Group B: Uninterrupted DOAC use (group 2)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Major Bleeding
Non-CABG related in-hospital bleeding (BARC 2, 3 or 5)
Time frame
30 daysSponsors and contacts
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Source ClinicalTrials.gov