RecruitingNot ApplicableNCT04977076

Comparison Between Direct Oral Anticoagulation (DOAC) Interruption and DOAC Continuation in Patients Undergoing Elective Invasive Coronary Angiography or Percutaneous Coronary Intervention

Sponsor

Zuyderland Medisch Centrum

Enrollment

1,270 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Coronary Artery Disease Anticoagulants

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

Min Age: 18 Years

Inclusion Criteria2

Patients aged >18 years using DOAC and undergoing elective ICA or PCI.
Provided signed informed consent

Exclusion Criteria17

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