Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04977076

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

Led by Zuyderland Medisch Centrum · Updated on 2026-05-29

1270

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Patients with atrial fibrillation (AF) often also have coronary artery disease (CAD), and many require coronary stenting. Direct Oral Anticoagulants (DOAC) are commonly used to prevent blood clots in AF patients, replacing older Vitamin-K Antagonists. This trial investigates the safety of continuing DOAC treatment without interruption during elective invasive coronary angiography (ICA) or percutaneous coronary intervention (PCI), as current guidelines recommend stopping DOACs 24-48 hours before these procedures but are based on limited evidence. The study is a prospective, multicenter, randomized trial focused on assessing bleeding risks related to uninterrupted DOAC use.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged over 18 years using DOAC and undergoing elective invasive coronary angiography or percutaneous coronary intervention
  • Provided signed informed consent
Not Eligible

You will not qualify if you...

  • Patients initially presenting with Acute Coronary Syndrome (STEMI, NSTEMI, UA)
  • Patients under 18 years old
  • Calculated creatinine clearance less than 30 mL/min
  • Patients simultaneously participating in another clinical trial
  • Major surgical procedure within 30 days before the procedure
  • Known inaccessible radial artery during previous procedure
  • History of gastrointestinal 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 less than 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) greater than 3 times the upper limit of normal
  • Participation in another clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day

Participants undergo elective invasive coronary angiography or percutaneous coronary intervention while either continuing or interrupting their DOAC medication as per their group assignment.

1 procedure visit (in-person)

Follow-up

Duration - 30 days

Participants are monitored for safety and complications including bleeding and thromboembolic events for 30 days after the procedure. They are also asked to complete a questionnaire about their experience.

1 follow-up visit and 1 questionnaire

Trial Site Locations

Total: 1 location

1

Zuyderland MC

Heerlen, Limburg, Netherlands, 6419PC

Actively Recruiting

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Research Team

S

Sanne Janssen, MSC

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Direct oral anticoagulation interruption vs continuation in patients undergoing elective invasive coronary angiography or percutaneous coronary intervention: Design and rationale of the South Limburg Myocardial Infarction Study Group Trial 2 (SLIM-2).

Sanne Janssen, Jasper J P Luijkx, Wouter Swinnen...

https://pubmed.ncbi.nlm.nih.gov/42055156