An interventional study of Uninterrupted DOAC use and Interrupted DOAC use in Atrial Fibrillation, Coronary Artery Disease and Anticoagulants, sponsored by Zuyderland Medisch Centrum. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Zuyderland Medisch Centrum · Not applicable, Interventional, and Prevention
A prospective, multicenter, 1:1 randomized, investigator initiated study. Goal of this study is to examine the safety of uninterrupted periprocedural DOAC use.
Rationale: Patients with atrial fibrillation (AF) often have coexisting coronary artery disease (CAD). An estimated 5 to 15% of all AF patients will require coronary stenting. Direct Oral Anticoagulants (DOAC) are more commonly used in preventing thromboembolic complications in patients with AF, thereby substituting the use of Vitamin-K Antagonists (VKA). Therefore, many patients undergoing invasive coronary angiography (ICA) and percutaneous coronary intervention (PCI) are taking direct oral anticoagulants (DOAC). In patients using VKA it is recommended to defer elective coronary angiography until international Normalized Ratio (INR) is \<2.2 when radial artery access is used. However, no large clinical trials have proven the safety of continuing DOAC use when undergoing ICA or PCI. The current guidelines recommend interrupting DOAC treatment at least 24 before ICA or PCI; however, this recommendation is only based on limited data. Clinical decisions on DOAC use must therefore be based on clinical trials in which substantial numbers of patients with Acute Coronary Syndrome (ACS) were included.
Objective: To study the safety of DOAC continuation in patients undergoing ICA or PCI.
Study design: A prospective, multicenter, 1:1 randomized, investigator initiated study.
Study population: Patients aged >18 years using DOAC and undergoing elective ICA or PCI.
Intervention: The intervention group will continue using DOAC as usual. No adjustments of DOAC use will be made before and after ICA or PCI. The control group will receive standard care. DOAC use will be interrupted at least 24-48 hours in advance of ICA or PCI, based on renal clearance and DOAC specimen.
Main study parameters/endpoints: : Non-coronary artery bypass graft (CABG) related in-hospital bleeding (BARC 2, 3 or 5).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Only a small burden is associated with participation. Patients are asked to fill out a questionnaire after 30 days. Patients in the control group may have a mildly higher risk of thromboembolic complications and patients in the intervention group may have a mildly higher risk of bleeding complications.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 1,270 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Zuyderland Medisch Centrum is the lead sponsor of 64 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Any of the following:
History or condition associated with increased bleeding risk, as listed below:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in group 1 will receive standard care. Therefore, DOAC use will be interrupted at least 24 hours in advance of ICA or PCI. Based on the renal clearance, last DOAC intake may be extended to 48 hours prior to the procedure \[Table 2\]. After the procedure, patients will continue using their DOAC as usual.
Other: Interrupted DOAC use
In group 2, all patients will continue to use their specific DOAC as usual. This means that no adjustments of DOAC use will be made before and after ICA or PCI. After the procedure patients will continue to use DOAC from the next planned dose.
Other: Uninterrupted DOAC use
Continuing DOAC use in advance of elective ICA or PCI.
Usual care, interruption of DOAC prior to procedure.
Major Bleeding
Non-CABG related in-hospital bleeding (BARC 2, 3 or 5)
Time frame: 30 days
Plan to share: No
Started Sep 2022 (actual). Primary completion is estimated for Dec 2027, 63 months after the start.
Of 796 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 63 months is above that.
Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
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Zuyderland Medisch Centrum