STREAMLINE

Strategies for antiplatelet management following acute coronary syndrome

Financed by : Consejería de Presidencia, Sanidad y Emergencias de la Junta de Andalucía

Program: EffecTrial 2025 (ERA4Health JTC 2025)

Project National Reference: HOR-2026-08

Role in the project: Partner

Duration: April 2026 to March 2030

 

Contact: Francesco Costa

Implementation Centre: Virgen de la Victoria University Hospital

Research group of IBIMA involved: Cardiovascular Research for Health

Abstract

Acute coronary syndrome (ACS) is a major cardiovascular condition associated with high morbimortality and healthcare costs. STREAMLINE is a pragmatic, multicenter (66 centers in 6 countries), investigator-initiated clinical trial designed to address critical gaps in evidence on antiplatelet therapy after ACS. Current guidelines recommend 12 months of dual antiplatelet therapy (DAPT) combining aspirin and a potent P2Y12 inhibitor(i) (prasugrel or ticagrelor) as the standard strategy to reduce recurrent ischemic events. However, this strategy increases the risk of bleeding, particularly in vulnerable populations such as the elderly.
This trial tests 2 hypotheses:

  1. An abbreviated DAPT strategy (3 months of aspirin+P2Y12 inhibitor followed by single antiplatelet therapy [SAPT] with a potent P2Y12i) is non-inferior to the standard 12 mo DAPT strategy in preventing recurrent ischemic events while significantly reducing bleeding.
  2. A prasugrel-based abbreviated DAPT strategy is superior to a ticagrelor-based abbreviated DAPT strategy in reducing ischemic events without increasing bleeding.

The trial will enroll 8,100 ACS patients from 6 European countries, ensuring representation across diverse populations and high-risk groups. Patients will undergo sequential randomization into 2 arms: 2:1 for abbreviated vs. standard DAPT, followed by 1:1 for prasugrel vs. ticagrelor in the abbreviated group. Primary endpoints include the composite of death, non-fatal myocardial infarction, or stroke at 1 year, analyzed for non-inferiority (first hypothesis) and superiority (second hypothesis). Major bleeding (BARC 3-5) is the main secondary outcome.

This trial is expected to generate robust, high-impact evidence to guide clinical practice, optimize antiplatelet strategies, and improve outcomes for ACS patients, particularly those more vulnerable. Results will inform guideline committees, policymakers, and clinicians, contributing to safer and more effective treatment protocols for ACS.

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Aknowledgment

This study received funding from Consejería de Presidencia, Sanidad y Emergencias de la Junta de Andalucía (REF: HOR-2026-08) under the umbrella of the Partnership Fostering a European Research Area for Health (ERA4Health) (GA N° 101095426 of the EU Horizon Europe Research and Innovation Programme)