DOACs: continue or pause around elective heart artery procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, randomized trial where adults on a DOAC undergoing elective ICA or PCI are assigned to continue DOACs or interrupt them. The primary aim is to evaluate safety outcomes of uninterrupted DOAC use around the procedure. The trial is investigator-initiated, with parallel groups in real-world clinical settings. Enrollment is 1:1, and no DOAC dose adjustments are mandated before the procedure. Outcomes will inform guidelines on periprocedural DOAC management in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• Zuyderland MC
  Heerlen, Limburg, Netherlands Recruiting

Study contacts

• Study coordinator: Sanne Janssen, MSC
• Email: sanne.janssen@zuyderland.nl
• Phone: 08854597522

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.