Comparison Between Direct Oral Anticoagulation (DOAC) Interruption and DOAC Continuation in Patients Undergoing Elective Invasive Coronary Angiography or Percutaneous Coronary Intervention (SLIM-2)

May 26, 2026 updated by: Zuyderland Medisch Centrum
A prospective, multicenter, 1:1 randomized, investigator initiated study. Goal of this study is to examine the safety of uninterrupted periprocedural DOAC use.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

1270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Interrupted DOAC use (group 1)
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
Usual care, interruption of DOAC prior to procedure.
Experimental: Uninterrupted DOAC use (group 2)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Bleeding
Time Frame: 30 days
Non-CABG related in-hospital bleeding (BARC 2, 3 or 5)
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zuyderland Medisch Centrum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

July 20, 2021

First Submitted That Met QC Criteria

July 20, 2021

First Posted (Actual)

July 26, 2021

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METCZ20210099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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