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AzTrials

Percutaneous Coronary Intervention (PCI)Phase 4MATRIX-2NCT05955365

Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation

A Phase 4 study testing P2Y12 inhibitor, Aspirin and DOAC in people with Percutaneous Coronary Intervention (PCI) and Atrial Fibrillation (AF), run by Insel Gruppe AG, University Hospital Bern at 15 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation require treatment with different antithrombotic drugs. Oral anticoagulants are prescribed to reduce the risk of stroke associated with atrial fibrillation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
P2Y12 inhibitor, Aspirin and DOAC
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,010 participants
Where
15 sitesin 9 countries
Study dates
18 Dec 2023to 30 Jun 2028
Phase
Phase 4
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

  • Age ≥18 years
  • Atrial fibrillation or flutter with an indication for oral anticoagulation using direct-acting oral anticoagulants (DOACs) for ≥12 months
  • Successful percutaneous coronary intervention in at least 1 lesion within the previous 7 days with no remaining lesions intended for treatment.
  • Free from major adverse events post qualifying PCI, including new onset chest pain suspected to be of ischemic origin, acute or subacute stent thrombosis, new-onset neurological signs or symptoms.
  • Written informed consent

Who cannot join

  • Planned staged percutaneous intervention procedure (Patients can be enrolled after complete coronary revascularization with no remaining lesions intended for treatment. Patients who have or develop indication to percutaneous valve intervention can undergo treatment more than 30 days after qualifying PCI.)
  • Cardioversion for treatment of atrial fibrillation within 1 month prior to inclusion or planned cardioversion
  • AF ablation procedure within 2 months prior to inclusion or planned AF ablation procedure
  • Prior mechanical valvular prosthesis implantation
  • Deep vein thrombosis/pulmonary embolism, at least moderately severe mitral stenosis or other clinical conditions than atrial fibrillation requiring long-term oral anticoagulation
  • Stroke within 1 month prior to randomization
Show all 15Show fewer
  • Hemodynamic instability (persistent systolic blood pressure below 90 mmHg, continuous infusions of catecholamines, clinical signs of hypoperfusion and/or use of percutaneous left ventricular assist devices)
  • Uncontrolled severe hypertension with a systolic blood pressure (BP) ≥180 mmHg and/or diastolic BP ≥120 mmHg
  • Severe renal impairment with estimated creatinine clearance (CrCL) <15 mL/min or on dialysis
  • Moderate or severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy
  • Any hypersensitivity or contraindications for direct oral anticoagulation or dual antiplatelet therapy with aspirin and a P2Y12 inhibitor
  • Any of the following abnormal local laboratory results prior to randomization: platelet count <50 x109/L or hemoglobin <8 g/dL
  • Known pregnancy or breast-feeding patients
  • Life expectancy <1 year due to other severe non-cardiac disease
  • Planned surgery including coronary artery bypass grafting within the next 6 months

Trial locations and contacts

15 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Stephan Windecker, Prof. contact

+41 31 632 44 97

Stephan.Windecker@insel.ch

Marco Valgimigli, Prof contact

+41 91 805 31 11

Marco.Valgimigli@eoc.ch

15 sites in 9 countries

Switzerland5 sites, 5 recruiting

  • Universitätsspital Basel

    Basel, 4031

    Christoph Kaiser, Prof, christoph.kaiser@usb.ch

    Gregor Leibundgut, Prof, gregor.leibundgut@usb.ch

    Recruiting

  • Inselspital, Bern University Hospital, Department of Cardiology

    Bern, 3010

    Stephan Windecker, Prof, +41 31 63 2 44 97, Stephan.Windecker@insel.ch

    André Frenk, PhD, + 41 31 632 19 16, andre.frenk@insel.ch

    Recruiting

  • Hôpitaux Universitaires de Genève

    Geneva, 1211

    Marco Roffi, Prof, +41 22 372 75 31, marco.roffi@hcuge.ch

    Recruiting

  • Cardiocentro Ticino Institute

    Lugano, Canton Ticino, 6900

    Marco Valgimigli, Prof, +41 91 805 31 11, Marco.Valgimigli@eoc.ch

    Daniel Sürder, MD, daniel.suerder@eoc.ch

    Recruiting

  • University Hospital Zürich

    Zurich, 8091

    Barbara Elisabeth Stähli, Prof, 0041 43 253 05 97, barbara.staehli@usz.ch

    Recruiting

Other trials in Switzerland

Germany2 sites, 2 recruiting

  • Universitätsklinikum Frankfurt/Main

    Frankfurt am Main, 60590

    David M. Leistner, Prof, david.leistner@kgu.de

    Not yet recruiting

  • Klinikum Friedrichshafen

    Friedrichshafen, 88048

    Julia Seeger, Priv.-Doz., seeger.julia@medizincampus.de

    Not yet recruiting

Other trials in Germany

Italy2 sites, 2 recruiting

  • Ospedale Ferrarotto

    Catania, Catania CT, 95124

    Davide F.M. Capodanno, Prof, dcapodanno@gmail.com

    Not yet recruiting

  • IRCCS Humanitas

    Milan, Rozzano, 20089

    Giulio Stefanini, Prof, giulio.stefanini@hunimed.eu

    Not yet recruiting

Other trials in Italy

Belgium1 site, 1 recruiting

  • Hartcentrum Hasselt

    Hasselt, 3500

    Pascal Vranckx, Prof, pascal.vranckx@jessazh.be

    Not yet recruiting

Other trials in Belgium

France1 site, 1 recruiting

  • CHU Nîmes

    Nîmes, 30029

    Guillaume Cayla, Prof, cayla.guillaume@gmail.com

    Not yet recruiting

Other trials in France

Netherlands1 site, 1 recruiting

  • UMC public

    Amsterdam, 1081

    Joanna J. Wykrzykowska, PhD, j.j.wykrzykowska@umcg.nl

    Not yet recruiting

Other trials in Netherlands

Poland1 site, 1 recruiting

  • Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu

    Poznan, 61-701

    Maciej Lesiak, Prof, maciej.lesiak@skpp.edu.pl

    Not yet recruiting

Other trials in Poland

Spain1 site, 1 recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

    Josè M. De La Torre Hernandez, MD, josemariadela.torre@scsalud.es

    Not yet recruiting

Other trials in Spain

United Kingdom1 site, 1 recruiting

  • Imperial College London

    London, SW7 2AZ

    Diana Gorog, Prof, d.gorog@imperial.ac.uk

    Not yet recruiting

Other trials in United Kingdom

About this study

Official title: Monotherapy With a P2Y12 Inhibitor Followed by a Direct-acting Oral Anticoagulant in Patients With ATRial fIbrillation Undergoing suprafleX Cruz Coronary Stent Implantation

Patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation require treatment with different antithrombotic drugs. Oral anticoagulants are prescribed to reduce the risk of stroke associated with atrial fibrillation. Antiplatelet substances are prescribed after stent implantation to reduce the risk of adverse cardiac events such as myocardial infarction or stent thrombosis. Treatment with antithrombotic medications can cause bleeding complications, particularly when these substances are combined.

The currently recommended standard strategy consists of treatment with 3 antithrombotic medications for at least 1 week up to one month, followed by treatment with two of these medications for up to 6-12 months after stent implantation. Thereafter, patients usually receive long-term treatment with only one drug, an anticoagulant.

Read more

In the monotherapy group of this study, the investigators will investigate a strategy where only one antithrombotic drug will be used at a time. During the first month after stent implantation, the investigators will prescribe an antiplatelet medication, followed by an oral anticoagulant as monotherapy. This strategy might be associated with fewer bleeding complications, while protecting adequately against thrombotic events.

In this study the investigators would like to investigate whether treatment with a single antithrombotic drug ("monotherapy strategy") is associated with benefits compared to the currently recommended combination therapy of antithrombotic medications ("standard-of-care strategy").

Read the detailed description

Background:

The optimal antithrombotic treatment following percutaneous coronary intervention (PCI) in patients with atrial fibrillation (AF) requiring long-term oral anticoagulation remains a matter of debate. In particular, the appropriate intensity and duration of antithrombotic strategies to prevent ischemic events, while mitigating the risk of bleeding complications in this high bleeding risk population during the early peri-procedural period (within 30 days) and thereafter (from 30 days to 1 year) following drug-eluting stent implantation remains unclear.

Aim:

The investigators aim to assess the safety and efficacy of a P2Y12 inhibitor monotherapy regimen for 1 month followed by DOAC monotherapy long-term versus current standard of care consisting of triple antithrombotic therapy for up to one month (aspirin, P2Y12 inhibitor and DOAC) followed by dual antithrombotic therapy (P2Y12 inhibitor and DOAC) for 6 to 12 months and DOAC monotherapy thereafter, in AF patients undergoing PCI indicated for treatment with a DOAC after sirolimus-eluting Supraflex Cruz stent implantation and followed for a period of 12 months.

Methodology:

This investigator-initiated, multi-center, randomized, open-label, blinded evaluation, international clinical trial in 3010 AF patients with indication for long-term oral anticoagulation who have undergone successful PCI with Supraflex Cruz sirolimus-eluting biodegradable polymer cobalt chromium stent implantation. The study will be conducted at approximately 150 sites across Europe and Brazil. Patients will be randomized to the antithrombotic monotherapy (experimental antithrombotic strategy) or the standard of care strategy (control group) in a 1:1 ratio. Randomization is stratified by site, acute coronary syndrome (ACS) within the previous 6 months and CHA2DS2-VASc score ≥4. Patients randomized to the antithrombotic monotherapy treatment receive any of the commercially available oral P2Y12 inhibitors (clopidogrel, ticagrelor, prasugrel) and immediately discontinue aspirin and DOAC. After 1 month, the P2Y12 inhibitor will be stopped and treatment with a commercially available DOAC will be initiated for the duration of 11 months. Patients randomized to the standard of care strategy will initiate triple therapy for up to 1 month followed by dual anti-thrombotic therapy (consisting of P2Y12 inhibitor for a minimum of 6 and up to 12 months plus DOAC for at least 12 months).

Potential significance:

This is the first study investigation the impact of a short course of P2Y12 inhibitor monotherapy up to 1 month, while omitting clopidogrel non-responders, and temporarily omitting OAC, after stent implantation followed by OAC monotherapy in AF patients undergoing PCI. This sequential monotherapy treatment strategy has solid rational and carries potential to balance bleeding against cardiac and cerebral ischemic risks.

Being tested
P2Y12 inhibitor, Aspirin, DOAC
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • P2Y12 inhibitorDrug

    The choice of P2Y12 inhibitor is left at investigator's discretion.

  • AspirinDrug

    Aspirin is administered for up to 1 month after PCI at investigator's discretion

  • DOACDrug

    The choice of DOAC is left at investigator's discretion.

Study groups in NCT05955365
Study groupRoleWhat they receive
Monotherapy strategyExperimentalPatients randomized to the monotherapy treatment arm receive any of the commercially available oral P2Y12 inhibitors (clopidogrel, prasugrel oder ticagrelor) and immediately discontinue aspirin and DOAC (or will not re-start DOAC after PCI if treatment was temporarily stopped before). After 1 month, the P2Y12 inhibitor will be stopped and treatment with a commercially available DOAC (at investigator's discretion and dosed according to the instructions for use in patients with atrial fibrillation) will be initiated for the duration of 11 months. After completion of the 12-month study regimen (study visit), the patient will receive antithrombotic therapy according to routine care.
Receives: Drug: P2Y12 inhibitor; Drug: DOAC
Standard of care strategyActive comparatorPatients randomized to the standard of care, receive DOAC for at least 12 months. In addition, aspirin is administered for up to 1 month after PCI at investigator's discretion and one of the available P2Y12 inhibitors (clopidogrel, prasugrel oder ticagrelor at investigator's discretion) is administered for a minimum of 6 months and up to 12 months after PCI. After completion of the 12-month control arm regimen (study visit), the patients will be treated according to routine care.
Receives: Drug: P2Y12 inhibitor; Drug: Aspirin; Drug: DOAC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of participants with a major adverse cardiac or cerebral events (MACCE), defined as the composite of death from any cause, myocardial infarction, stroke or non-central nervous system (non-CNS) systemic embolism

    Measured: 12 months

  2. The number of participants with a major or clinically relevant non-major bleeding (MCB), defined according to the International Society of Thrombosis and Haemostasis (ISTH) criteria

    Measured: 12 months

Secondary outcomes (37)

  1. The incidence of MACCE or MCB

    MACCE, defined as the composite of death from any cause, myocardial infarction, stroke or non-CNS systemic embolism and MCB, defined according to the ISTH criteria

    Measured: 12 months

  2. The incidence of MACCE or MCB

    MACCE, defined as the composite of death from any cause, myocardial infarction, stroke or non-CNS systemic embolism and MCB, defined according to the ISTH criteria

    Measured: 15 months

  3. The number of participants with a composite of death from cardiovascular causes, myocardial infarction or stroke

    Measured: 12 months

  4. The number of participants with a composite of death from cardiovascular causes, myocardial infarction or stroke

    Measured: 15 months

  5. The number of participants with a composite of death from cardiovascular causes, myocardial infarction, stroke or non-CNS systemic embolism

    Measured: 12 months

  6. The number of participants with a composite of death from cardiovascular causes, myocardial infarction, stroke or non-CNS systemic embolism

    Measured: 15 months

  7. The number of participants died from cardiovascular or non-cardiovascular causes

    Measured: 12 months

  8. The number of participants died from cardiovascular or non-cardiovascular causes

    Measured: 15 months

  9. The number of participants with a composite of stroke and non-CNS systemic embolism

    Measured: 12 months

  10. The number of participants with a composite of stroke and non-CNS systemic embolism

    Measured: 15 months

  11. The number of participants with any stroke (including ischemic, hemorrhagic and unknown types)

    Measured: 12 months

  12. The number of participants with any stroke (including ischemic, hemorrhagic and unknown types)

    Measured: 15 months

  13. The number of participants with an ischaemic stroke

    Measured: 12 months

  14. The number of participants with an ischaemic stroke

    Measured: 15 months

  15. The number of participants with a hemorrhagic stroke

    Measured: 12 months

  16. The number of participants with a hemorrhagic stroke

    Measured: 15 months

  17. The number of participants with a transient ischemic attack

    Measured: 12 months

  18. The number of participants with a transient ischemic attack

    Measured: 15 months

  19. The number of participants with a composite of definite or probable stent thrombosis

    Measured: 12 months

  20. The number of participants with a composite of definite or probable stent thrombosis

    Measured: 15 months

  21. The number of participants with a definite stent thrombosis

    Measured: 12 months

  22. The number of participants with a definite stent thrombosis

    Measured: 15 months

  23. The number of participants with a hospitalization

    Measured: 12 months

  24. The number of participants with a hospitalization

    Measured: 15 months

  25. The number of participants with a composite of death or hospitalization

    Measured: 12 months

  26. The number of participants with a composite of death or hospitalization

    Measured: 15 months

  27. The number of participants with any target lesion revascularization

    Measured: 12 months

  28. The number of participants with any target lesion revascularization

    Measured: 15 months

  29. The number of participants with any target vessel revascularization

    Measured: 12 months

  30. The number of participants with any target vessel revascularization

    Measured: 15 months

  31. The number of participants with any revascularization

    Measured: 12 months

  32. The number of participants with any revascularization

    Measured: 15 months

  33. The number of all bleeding events, also adjudicated according to Bleeding Academic Research Consortium, Thrombolysis in Myocardial Infarction or Global Use of Strategies to Open Occluded Coronary Arteries scales

    The BARC is scaled from 0 to 5, with higher scores indicating worse outcomes, the TIMI from minor to major to fatal bleeding, and the GUSTO from mild to moderate to severe or life-threatening.

    Measured: 12 months

  34. The number of all bleeding events, also adjudicated according to Bleeding Academic Research Consortium, Thrombolysis in Myocardial Infarction or Global Use of Strategies to Open Occluded Coronary Arteries scales

    The BARC is scaled from 0 to 5, with higher scores indicating worse outcomes, the TIMI from minor to major to fatal bleeding, and the GUSTO from mild to moderate to severe or life-threatening.

    Measured: 15 months

  35. Transfusion rates both in patients with and/or without clinically detected overt bleeding

    Measured: 12 months

  36. Transfusion rates both in patients with and/or without clinically detected overt bleeding

    Measured: 15 months

  37. The number of participants with a major adverse cardiac or cerebral events (MACCE), defined as the composite of death from any cause, myocardial infarction, stroke or non-central nervous system (non-CNS) systemic embolism

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2023
  2. Study start18 Dec 2023
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,010 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05955365
Sponsor's protocol ID
MATRIX-2
Acronym
MATRIX-2
Status last verified
May 2026
First submitted
28 Jun 2023
Last updated
8 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing P2Y12 inhibitor, Aspirin and DOAC in people with Percutaneous Coronary Intervention (PCI) and Atrial Fibrillation (AF), run by Insel Gruppe AG, University Hospital Bern at 15 sites in 9 countries.

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 5 inclusion and 15 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 8 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 15 sites in Switzerland, Germany, Italy, Belgium, France and 4 more countries. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Stephan Windecker, Prof. (+41 31 632 44 97, Stephan.Windecker@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of participants with a major adverse cardiac or cerebral events (MACCE), defined as the composite of death from any cause, myocardial infarction, stroke or non-central nervous system (non-CNS) systemic embolism (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT05955365.

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 8 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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