Evaluation of PG413 Versus Apixaban in the Prevention of Stroke and Systemic Embolism in Adults with Non-Valvular Atrial Fibrillation and Treatment of Thromboembolism

The primary objective of this study is to compare the efficacy and safety of the new drug **PG413** produced by Celon Pharma SA with the established drug **Eliquis** in healthy volunteers. This comparison is clinically relevant as it aims to evaluate the potential of PG413 in the **prevention of stroke** and **systemic embolism** in adult patients with non-valvular **atrial fibrillation** (NVAF) who have one or more risk factors, such as prior stroke or transient ischemic attack (TIA), age ≥ 75 years, hypertension, diabetes mellitus, or symptomatic heart failure (NYHA Class ≥ II). Additionally, the study addresses the treatment of **deep vein thrombosis** (DVT) and **pulmonary embolism** (PE), as well as the prevention of recurrent DVT and PE in adults. The study does not specify any secondary objectives.

The clinical trial involves a study population comprising both **male** and **female** participants, with an age range of 18 to 64 years. The trial focuses on the **prevention of stroke** and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), who have one or more risk factors such as prior stroke or transient ischaemic attack (TIA), age 75 years or older, hypertension, diabetes mellitus, or symptomatic heart failure classified as NYHA Class II or higher. Additionally, the trial addresses the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as the prevention of recurrent DVT and PE in adults. The total number of participants is not provided by the sponsor. The trial population was selected without targeting any vulnerable groups, and no specific lifestyle considerations such as diet or physical activity are highlighted. Key inclusion or exclusion criteria are not specified in the available data.

The clinical trial is designed to evaluate the efficacy and safety of a new investigational drug, PG413, in comparison to the established medication, Eliquis, in healthy volunteers. This study is a **Phase 2** trial, which is typically conducted to assess the drug's efficacy and side effects. The trial employs a randomized, double-blind, controlled design to ensure unbiased results and to maintain the integrity of the data collected. The estimated duration of the trial is from March 3, 2025, to March 31, 2025, allowing for a comprehensive evaluation of the investigational drug over a specified period.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. This visit will involve a thorough assessment of the participant's health status and medical history to ensure they meet the necessary conditions for participation. Following successful screening, participants will be randomly assigned to receive either the investigational drug or the comparator, Eliquis, in a double-blind manner, meaning neither the participants nor the investigators will know which treatment is being administered.

Throughout the trial, participants will attend scheduled follow-up visits to monitor their health and any potential side effects. These visits are crucial for collecting data on the drug's efficacy and safety profile. The trial will conclude with an end-of-study visit, where final assessments will be conducted to evaluate the overall outcomes of the treatment. The expected length of participant involvement is approximately one month, aligning with the trial's estimated duration.

Participants may be subject to early termination from the study if they experience significant adverse effects, fail to comply with study protocols, or withdraw consent. The trial's design and procedures are structured to ensure the safety and well-being of all participants while providing valuable data on the investigational drug's potential benefits and risks in the prevention of **stroke** and systemic embolism in adult patients with non-valvular atrial fibrillation, as well as the treatment and prevention of recurrent **deep vein thrombosis** and **pulmonary embolism**.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these treatments can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be offered regarding these aspects of the clinical trial.

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to commence recruitment on March 3, 2025, with an estimated completion date of March 31, 2025. The efficacy assessment will be conducted using predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured protocol to ensure the collection and analysis of efficacy data, adhering to the standards expected in clinical research. The trial's design and execution will be aligned with regulatory requirements to ensure the reliability and validity of the efficacy outcomes.