About the study

ADONIS-PCI is a prospective, randomised, multicentre clinical trial evaluating the optimal antithrombotic treatment strategy for patients with acute coronary syndrome (ACS) and non-valvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI).

The project addresses an important clinical challenge: how to effectively prevent thrombosis and ischaemic events while reducing the risk of major bleeding in patients requiring complex antithrombotic therapy.

The study aims to determine whether a novel treatment strategy can provide efficacy comparable to standard triple therapy while offering improved safety.

Why is this study important?

In patients with acute coronary syndrome and atrial fibrillation, antithrombotic therapy is particularly challenging because treatment must simultaneously reduce the risk of stroke, stent thrombosis and recurrent ischaemic events.

Standard care often involves triple therapy combining an oral anticoagulant, aspirin and clopidogrel. However, this approach is associated with a substantial risk of major bleeding, which may reach up to 25% annually.

ADONIS-PCI investigates whether dual antithrombotic therapy with dabigatran and ticagrelor can maintain treatment efficacy while reducing bleeding risk.

What treatments are being compared?

The study compares two treatment strategies.

Patients in the investigational arm receive dual antithrombotic therapy consisting of ticagrelor and dabigatran. Patients in the control arm receive standard triple therapy consisting of clopidogrel, aspirin and dabigatran.

Randomisation takes place within 72 hours after PCI, and treatment continues for 12 months.

Study design

ADONIS-PCI is a multicentre, prospective, randomised, open-label, blinded-endpoint, non-inferiority trial.

The study plans to enrol a total of 2,230 patients, with 1,115 participants assigned to each treatment arm.

Both treatment safety and efficacy in preventing thromboembolic and cardiovascular events are evaluated.

Study endpoints

The primary endpoint is the first occurrence of major bleeding or clinically relevant non-major bleeding, defined according to ISTH criteria and analysed using a time-to-event model.

The primary secondary endpoint is a composite efficacy outcome including thromboembolic events, death, unplanned revascularisation, myocardial infarction, stroke or peripheral embolism.

Study population

Eligible participants are adults aged 18 years and older with non-valvular atrial fibrillation who have undergone successful PCI for acute coronary syndrome.

Atrial fibrillation may be paroxysmal, persistent or permanent but must not be secondary to a reversible cause such as recent myocardial infarction, pulmonary embolism, recent surgery, pericarditis or thyrotoxicosis.

Acute coronary syndrome includes STEMI, NSTEMI and unstable angina.

Research team

The principal investigator and study coordinator is Miłosz J. Jaguszewski, MD, PhD, Professor from the 1st Department of Cardiology, Medical University of Gdańsk.

The co-principal investigator is Aleksandra Gąsecka, MD, PhD from the Medical University of Warsaw.

The project also involves a broad network of investigators from cardiovascular centres across Poland.

Participating centres

ADONIS-PCI is conducted in specialised cardiology centres across Poland.

Organisational information

The project is funded by the Polish state budget through the Medical Research Agency (MRA) under the non-commercial clinical trials funding call ABM/2019/1.

Project number: 2019/ABM/01/00027.

Funding amount: PLN 13,180,818.30.

Coordinating institution: Medical University of Gdańsk.