Randomized Comparative Evaluation of Ticagrelor, Prasugrel, and Aspirin/Dipyridamole Combination Therapy for Antiplatelet Management in Acute Coronary Syndrome

The primary objective is to determine the incidence of the composite endpoint of all‑cause mortality, non‑fatal myocardial infarction, or stroke at 12 months in patients with acute coronary syndrome, providing a direct measure of long‑term cardiovascular risk under the investigated antiplatelet strategies.

Secondary objectives include:

• Incidence of each component of the primary composite endpoint.
• Death from cardiovascular causes.
• Unplanned revascularization.
• Net adverse clinical benefit defined as the composite of all‑cause mortality, non‑fatal myocardial infarction or stroke together with BARC grade 3–5 bleeding at 12 months.

The trial enrolled adult patients (≥18 years) of both sexes who were admitted for an acute myocardial infarction (STEMI or NSTEMI) and received invasive management with successful percutaneous coronary intervention during the index hospitalization; participants were required to be capable of providing informed consent. All subjects had a diagnosis of ischemic heart disease underlying their presentation. The sponsor did not provide information on the total number of participants or the specific age distribution beyond the inclusion of adults. Selection was based on the defined inclusion criteria, and no additional lifestyle restrictions (e.g., diet, physical activity, smoking) were specified in the available data.

The study is a Phase IV, low‑intervention trial evaluating antiplatelet strategies in patients with acute myocardial infarction undergoing successful percutaneous coronary intervention. Eligible participants are adults (≥18 years) admitted with STEMI or NSTEMI, receiving invasive management and able to provide consent. After a screening visit confirming eligibility, subjects are randomized to receive one of the oral test agents (ticagrelor, prasugrel, or acetylsalicylic acid + dipyridamole) at the specified doses. Follow‑up assessments are performed at scheduled intervals through 12 months post‑randomization, culminating in an end‑of‑study visit. The primary efficacy outcome is the incidence of the composite of all‑cause mortality, non‑fatal myocardial infarction or stroke at 12 months; the primary safety outcome is the incidence of major bleeding defined as BARC grade 3a‑5. Secondary outcomes include the individual components of the composite, cardiovascular death, net adverse clinical benefit (including BARC 3‑5 bleeding), unplanned revascularization, and BARC 2‑5 bleeding. Participant involvement spans approximately one year, and discontinuation may occur if consent is withdrawn, the subject experiences a protocol‑defined serious adverse event, or the investigator determines that continuation is not in the participant’s best interest. Recruitment commenced in May 2026 and is planned to conclude in May 2030.

The investigational antiplatelet regimen includes prasugrel hydrobromide supplied in the pharmaceutical form identified as PHF00082MIG. Each dose contains 60 mg and is administered orally. Dosing follows the study‑specified schedule, with each administration recorded to ensure adherence.

A second investigational product combines dipyridamole and acetylsalicylic acid in the formulation PHF00131MIG. The fixed‑dose tablet provides 100 mg of the combined agents and is taken orally according to the protocol‑defined timing. Administration times are logged and compliance is monitored through pill counts and participant diaries.

The third investigational agent is ticagrelor, also presented as PHF00082MIG. Each tablet delivers 180 mg and is given orally as directed by the dosing schedule outlined in the trial protocol. Compliance is assessed by regular study visits, medication accountability, and electronic adherence monitoring.

Efficacy will be evaluated by determining the incidence of the composite endpoint consisting of all‑cause mortality, non‑fatal myocardial infarction, or stroke during a 12‑month follow‑up period.

Clinical events will be captured through scheduled assessments at 12 months, with data collected from participant records, hospital discharge summaries, and investigator reports. Events will be classified according to standard definitions for mortality, myocardial infarction, and stroke, and adjudicated by an independent committee. Time‑to‑event analyses will be performed, including Kaplan‑Meier survival estimates and hazard ratios with corresponding confidence intervals.

Secondary efficacy assessments will include the incidence of each component of the primary composite, death from cardiovascular causes, a composite of net adverse clinical benefit (all‑cause mortality, non‑fatal myocardial infarction, stroke, and BARC grade 3‑5 bleeding), and unplanned revascularization procedures occurring after the index hospitalization. These secondary endpoints will be measured and analyzed using the same 12‑month follow‑up framework.