Atrial FibrillationSLIM-2NCT04977076
Comparison Between Direct Oral Anticoagulation (DOAC) Interruption and DOAC Continuation in Patients Undergoing Elective Invasive Coronary Angiography or Percutaneous Coronary Intervention
A study testing Uninterrupted DOAC use and Interrupted DOAC use in people with Atrial Fibrillation and Coronary Artery Disease, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
A prospective, multicenter, 1:1 randomized, investigator initiated study. Goal of this study is to examine the safety of uninterrupted periprocedural DOAC use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Coronary Artery Disease, Anticoagulants
- What is being tested?
- Uninterrupted DOAC use and Interrupted DOAC use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,270 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged >18 years using DOAC and undergoing elective ICA or PCI.
- Provided signed informed consent
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Zuyderland MC
Heerlen, Limburg, 6419PC
Sanne Janssen, MSc, sanne.janssen@zuyderland.nl
About this study
A prospective, multicenter, 1:1 randomized, investigator initiated study. Goal of this study is to examine the safety of uninterrupted periprocedural DOAC use.
Read the 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.
- Conditions
- Atrial Fibrillation, Coronary Artery Disease, Anticoagulants
- Being tested
- Uninterrupted DOAC use, Interrupted DOAC use
- Medical subject headings
- Atrial Fibrillation, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uninterrupted DOAC useOther
Continuing DOAC use in advance of elective ICA or PCI.
Interrupted DOAC useOther
Usual care, interruption of DOAC prior to procedure.
| Study group | Role | What they receive |
|---|---|---|
| Interrupted DOAC use (group 1) | Active comparator | 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. Receives: Other: Interrupted DOAC use |
| Uninterrupted DOAC use (group 2) | Experimental | 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. Receives: Other: Uninterrupted DOAC use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Bleeding
Non-CABG related in-hospital bleeding (BARC 2, 3 or 5)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Sep 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, multicenter, 1:1 randomized, investigator initiated study.
- Masking
- None (open label)
- Enrolment
- 1,270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977076
- Sponsor's protocol ID
- METCZ20210099
- Acronym
- SLIM-2
- Status last verified
- Oct 2025
- First submitted
- 20 Jul 2021
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Janssen S, Luijkx JJP, Swinnen W, Vriesendorp P, Ten Berg JM, van 't Hof AWJ, Rasoul S; SLIM-2 study group. 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). Am Heart J. 2026 Sep;299:107462. doi: 10.1016/j.ahj.2026.107462. Epub 2026 Apr 27.
PubMed 42055156
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Direct Oral Anticoagulation (DOAC) Interruption and DOAC Continuation in Patients Undergoing Elective Invasive Coronary Angiography or Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04977076
- Acronym / sponsor ID
- SLIM-2 / METCZ20210099
- Conditions
- Atrial Fibrillation, Coronary Artery Disease, Anticoagulants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,270 participants (estimated)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multicenter, 1:1 randomized, investigator initiated study. Goal of this study is to examine the safety of uninterrupted periprocedural DOAC use.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, multicenter, 1:1 randomized, investigator initiated study.
| Arm | Type | Receives |
|---|---|---|
| Interrupted DOAC use (group 1) | Active comparator | Other: Interrupted DOAC usePatients 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. |
| Uninterrupted DOAC use (group 2) | Experimental | Other: Uninterrupted DOAC useIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged >18 years using DOAC and undergoing elective ICA or PCI.
- Provided signed informed consent
Key exclusion criteria (17 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uninterrupted DOAC useContinuing DOAC use in advance of elective ICA or PCI. | Other | Uninterrupted DOAC use (group 2) |
| Interrupted DOAC useUsual care, interruption of DOAC prior to procedure. | Other | Interrupted DOAC use (group 1) |
Primary outcome
Major Bleeding
Time frame: 30 days
Non-CABG related in-hospital bleeding (BARC 2, 3 or 5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Derived from this study: PubMed 42055156Janssen S, Luijkx JJP, Swinnen W, Vriesendorp P, Ten Berg JM, van 't Hof AWJ, Rasoul S; SLIM-2 study group. 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). Am Heart J. 2026 Sep;299:107462. doi: 10.1016/j.ahj.2026.107462. Epub 2026 Apr 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uninterrupted DOAC use and Interrupted DOAC use in people with Atrial Fibrillation and Coronary Artery Disease, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanne Janssen, MSC (08854597522, sanne.janssen@zuyderland.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Bleeding (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04977076, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.