At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- P2Y12 inhibitor (drug), Aspirin (drug), DOAC (drug)
- How long the study runs
- Study runs about 54 months (dates as stated)
- About the drug or intervention
- P2Y12 inhibitor — drug: The choice of P2Y12 inhibitor is left at investigator's discretion. · Aspirin — drug: Aspirin is administered for up to 1 month after PCI at investigator's discretion · DOAC — drug: The choice of DOAC is left at investigator's discretion.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at people with atrial fibrillation (an irregular heart rhythm) who have had a procedure called percutaneous coronary intervention (PCI), which uses a small tube to place a mesh tube (stent) in a heart artery to open it up. The researchers want to study treatment with a single type of blood-thinning medicine called a P2Y12 inhibitor, instead of other combinations of blood-thinning medicines.
Who can take part
- Aged 18 or over
- Have atrial fibrillation or atrial flutter (irregular heart rhythms) and need blood-thinning medicine (direct-acting oral anticoagulants, known as DOACs) for at least 12 months
- Had a successful stent procedure (PCI) in at least one narrowed heart artery within the previous 7 days, with no other narrowed arteries left to treat
- Free of serious problems after the stent procedure, such as new chest pain thought to come from the heart, a blocked stent, or new nervous system signs or symptoms
- Able to give written informed consent
Who may not be able to
- A further planned stent procedure that has not yet been done
- Electric shock treatment (cardioversion) for atrial fibrillation within the last month, or one planned
- An ablation procedure for atrial fibrillation within the last 2 months, or one planned
- A previous mechanical heart valve replacement
- Blood clots in the leg or lung, moderate or severe narrowing of the mitral heart valve, or any other condition needing long-term blood thinners
- A stroke within the last month
- Unstable blood pressure or blood flow (for example, very low blood pressure or needing medicine drips to keep the heart going)
- Very high blood pressure that is not controlled (180/120 mmHg or above)
- Severe kidney problems (very low kidney clearance or on dialysis)
- Moderate or severe liver problems, or liver disease affecting blood clotting
- Allergy to or unable to take the blood-thinning or anti-clotting medicines used in this study
- Very low platelet count or very low haemoglobin (a blood test result)
- Pregnant or breastfeeding
- Expected to live less than 1 year due to another serious illness
- Surgery planned in the next 6 months, including heart bypass surgery
What taking part involves
- • Taking a single anti-clotting medicine called a P2Y12 inhibitor, rather than other combinations of blood-thinning medicines
- • Continuing blood-thinning medicine (direct-acting oral anticoagulants, known as DOACs) for at least 12 months
Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 3,010
- Started
- 2023-12-18
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for percutaneous coronary intervention (pci)
- • Phase4 - 3,010 participants
- • Patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation require treatment with different antithrombotic drugs
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with percutaneous coronary intervention (pci)
Where?
- • London - Imperial College London
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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. 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").
More detail
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.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Age ≥18 years
- ✓Atrial fibrillation or flutter with an indication for oral anticoagulation using direct-acting oral anticoagulants...
- ✓Successful percutaneous coronary intervention in at least 1 lesion within the previous 7 days with no remaining...
- ✓Free from major adverse events post qualifying PCI, including new onset chest pain suspected to be of ischemic...
- ✓Written agreement to take part
Who cannot take part
- ✗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/lung embolism, at least moderately severe mitral stenosis or other clinical conditions...
- ✗Stroke within 1 month prior to randomization
See the full criteria
Where Is This Study? (1 UK site)
Imperial College London
London SW7 2AZ, United Kingdom
How to Get in Touch
Stephan Windecker, Prof.
Sponsor contactCONTACT
Marco Valgimigli, Prof
Sponsor contactCONTACT