Comparison Between Direct Oral Anticoagulation (DOAC) Interruption and DOAC Continuation in Patients Undergoing Elective Invasive Coronary Angiography or Percutaneous Coronary Intervention
Uninterrupted DOAC use: Continuing DOAC use in advance of elective ICA or PCI.
Interrupted DOAC use: Usual care, interruption of DOAC prior to procedure.
Study summary
A prospective, multicenter, 1:1 randomized, investigator initiated study. Goal of this study is to examine the safety of uninterrupted periprocedural DOAC use.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients aged \>18 years using DOAC and undergoing elective ICA or PCI.
* Provided signed informed consent
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Any of the following:
* 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
* History or condition associated with increased bleeding risk, as listed below:
* Major surgical procedure within 30 days before the procedure
* Known inaccessible radial artery during previous procedure
* History of GI bleeding in the previous 6 months
* History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding
* Chronic bleeding disorder
* Known intracranial neoplasm, arteriovenous malformation, or aneurysm
* Known anemia with last measured haemoglobin value \<6 mmol/L \[9.67 g/dL\]
* Current pregnancy or breast-feeding
* Known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis), or Alanine aminotransferase (ALT) \>3 x the upper limit of normal.
* Participation in another clinical trial
Primary outcome measure(s)
Major Bleeding — 30 days Non-CABG related in-hospital bleeding (BARC 2, 3 or 5)
Trial sites (1)
Facility
City
Region
Status
Zuyderland MC
Heerlen
Limburg
Recruiting
More Zuyderland Medisch Centrum trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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