Comparative Efficacy of Dual Therapy with Dabigatran and Ticagrelor versus Dabigatran and Clopidogrel in Acute Coronary Syndrome Patients Undergoing PCI

The primary objective of the study is to conduct a real-world registry-based randomized controlled trial to compare **dual therapy** with Dabigatran/Ticagrelor to Dabigatran/Clopidogrel in patients with an indication for **NOAC** undergoing **PCI** in the setting of **acute coronary syndrome**. This comparison is clinically relevant as it aims to evaluate the efficacy and safety of these dual therapy regimens in a real-world setting, potentially influencing treatment guidelines for patients with acute coronary syndrome who require percutaneous coronary intervention.

The clinical trial involves participants diagnosed with **acute coronary syndrome** who are undergoing percutaneous coronary intervention (PCI) with drug-eluting stents. The study population includes both male and female subjects aged 18 years and older. Participants are required to have an indication for non-vitamin K antagonist oral anticoagulants (NOACs) or be starting oral anticoagulation therapy, with eligibility extended to those with permanent, persistent, or paroxysmal atrial fibrillation. The trial does not include a vulnerable population. The sponsor has not provided the total number of participants. Selection criteria emphasize the balance between bleeding risk and thromboembolic events, with additional considerations for patients admitted with unstable angina, NSTEMI, STEMI, or those undergoing high-risk PCI procedures. Lifestyle factors such as diet and physical activity are not specified in the trial data.

The clinical trial is designed as a **randomized controlled trial** to evaluate the efficacy and safety of dual therapy with **Dabigatran** and **Ticagrelor** compared to **Dabigatran** and **Clopidogrel** in patients with **acute coronary syndrome** (ACS) undergoing percutaneous coronary intervention (PCI). The trial will involve a real-world registry approach, with participants being randomly assigned to one of the two treatment groups. The study is expected to last for approximately 12 months, with the estimated recruitment start date being March 16, 2021, and the estimated end date being May 7, 2025.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on criteria such as age (≥18 years), successful stenting with a drug-eluting stent, and an indication for non-vitamin K antagonist oral anticoagulants (NOACs). Following the screening, participants will be enrolled and randomized into the study. Regular follow-up visits will be scheduled to monitor the occurrence of the primary endpoint, which is the first bleeding event as defined by the Bleeding Academic Research Council (BARC) score ≥2. Secondary endpoints include thromboembolic events such as myocardial infarction, stroke, systemic embolism, and death.

The expected length of participant involvement is 12 months, during which they will be required to adhere to the assigned treatment regimen and attend all scheduled visits. Conditions that may lead to early termination from the study include withdrawal of consent, significant protocol deviations, or adverse events that necessitate discontinuation of the study medication. The end-of-study visit will occur at the conclusion of the 12-month follow-up period, where final assessments will be conducted to evaluate the overall outcomes of the trial.

The clinical trial involves the administration of **Ticagrelor**, a chemical compound with the active substance name **Ticagrelor** and synonym **AZD6140**. Ticagrelor is classified under the ATC code **B01AC24** and is used as an antithrombotic agent. The pharmaceutical form of Ticagrelor is denoted as **PHF00009MIG**, and it is administered orally. The maximum daily dose is 180 mg, with the same amount being the maximum total dose. The treatment period for Ticagrelor is up to 12 months. The medication is not a pediatric formulation and is not classified as an orphan drug. Participant compliance with the dosing schedule will be monitored throughout the trial.

In addition to Ticagrelor, the study involves a comparison with dual therapy using Dabigatran and Clopidogrel. These non-experimental treatments serve as comparator therapies in the trial. The objective is to evaluate the efficacy of dual therapy with Dabigatran/Ticagrelor versus Dabigatran/Clopidogrel in patients with an indication for NOAC undergoing PCI in the setting of ACS. The trial is designed as a real-world registry-based randomized controlled trial. Compliance with the administration of these comparator treatments will also be monitored to ensure adherence to the study protocol.

Efficacy in the clinical trial titled "RE-DUAL TICLO PCI: Dual Therapy with dabigatran/ticagrelor versus Dual Therapy with dabigatran/clopidogrel in ACS patients with indication for NOAC undergoing PCI" will be assessed through several secondary endpoints. These endpoints include the occurrence of **thromboembolic events** such as myocardial infarction, stroke, systemic embolism, and death. Additionally, a composite endpoint of thromboembolic events or death, as well as individual thromboembolic events and stent thrombosis, will be evaluated. The assessment of these endpoints will provide insights into the efficacy of the dual therapy regimens being compared in the study.