Dual Antiplatelet Therapy Strategies After Acute Myocardial Infarction Undergoing PCI: Prasugrel vs Ticagrelor & 12 Months vs 1-3 Months

NCT07507500 | Not Yet Recruiting Phase 4

• 1 other identifier: STREAMLINE
• Study Type: interventional
• Target: 8,100
• Locations: 5 countries
• Sites: 5

Brief Summary

This study is testing different blood-thinning treatment strategies for people who have had a heart attack and were successfully treated with a coronary stent procedure (PCI). All strategies tested are already approved for this condition and used inversally. This study will define which of the approved strategies is the best one. After PCI, patients usually receive two antiplatelet medicines for up to 12 months to help prevent another heart attack or stroke, but this treatment can also increase bleeding risk. This study will compare a shorter course of dual antiplatelet therapy followed by one antiplatelet medicine alone versus the standard 12-month course. In addition, the study will compare two commonly used antiplatelet drugs, prasugrel and ticagrelor. The goal is to find out which strategy best prevents death, heart attack, or stroke while minimizing serious bleeding. This study is not testing any new intervention, rather comparing approved drugs and approved durations of use.

Conditions

Myocardial Infarction (MI)

Keywords

acute coronary syndrome; infarction; DAPT; dual antiplatelet therapy; prasugrel; ticagrelor; ischemic event; bleeding

Outcome Measures

Primary Outcomes (1)

• ischemic events

  incidence of the composite of "all-cause death, reinfarction or stroke"

  12 months

Secondary Outcomes (6)

• All-cause death

  12 months

• Reinfarction

  12 months

• stroke

  12 months

• cardiovascular death

  12 months

• Unplanned revascularization

  12 months

Other Outcomes (1)

• Safety outcome (bleeding)

  12 months

Study Arms (4)

Prasugrel 12 months DAPT

ACTIVE COMPARATOR

Prasugrel-based 12 months DAPT

Drug: Prasugrel

Prasugrel abbreviated DAPT

EXPERIMENTAL

Prasugrel-Based DAPT for 1 to 3 Months, Followed by Prasugrel Monotherapy Through 12 Months After MI

Drug: Prasugrel

Ticagrelor 12 months DAPT

EXPERIMENTAL

Ticagrelor-based 12 months DAPT

Drug: Ticagrelor

Ticagrelor abbreviated DAPT

EXPERIMENTAL

Ticagrelor-Based DAPT for 1 to 3 Months, Followed by Prasugrel Monotherapy Through 12 Months After MI

Drug: Ticagrelor

Interventions

Prasugrel DRUG

Prasugrel during 12 months

Prasugrel 12 months DAPT; Prasugrel abbreviated DAPT

Ticagrelor DRUG

Ticagrelor plus aspirin

Ticagrelor 12 months DAPT; Ticagrelor abbreviated DAPT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• Admitted because of an acute MI (either STEMI or NSTEMI).
• Invasive management during index admission with successful PCI.
• Able to consent.

You may not qualify if:

• Indication for oral anticoagulation therapy.
• Intolerance, contraindication or known allergy to either aspirin, prasugrel or ticagrelor.
• Prior history of ischaemic or haemorrhagic stroke or transient ischaemic attack.
• Patients with active bleeding or known bleeding disorders.
• Patients with known moderate or severe hepatic dysfunction (Child-Pugh Class B or Class C).
• Known intracranial aneurism, arteriovenous malformation or neoplasm.
• Patients with chronic kidney disease requiring dialysis.
• Any disorder that may interfere with drug absorption.
• Pregnancy or current lactation.
• Concomitant use of potent CYP3A inhibitors or inducers.
• Planned elective surgery that cannot be deferred 12 months before randomization, requiring interruption of antiplatelet therapy.
• Any medical condition that, in the investigator´s judgment, would seriously limit life expectancy (less than one year)
• Active participation in other clinical trials.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead
• Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III: collaborator

Study Sites (5)

Mater Private Network Dublin

Dublin, Ireland

Location

Paula Stradiņa klīniskā universitates slimnīca

Riga, Latvia

Location

Oslo University Hospital, Ullevål.

Oslo, Norway

Location

Saint John Paul II Hospital in Cracow

Krakow, Poland

Location

Fundación Jiménez Díaz University Hospital

Madrid, Spain

Location

MeSH Terms

Conditions

Myocardial Infarction; Acute Coronary Syndrome; Infarction; Hemorrhage

Interventions

Prasugrel Hydrochloride; Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Borja Ibanez, MD PhD

  Centro Nacional de Investigaciones Cardiovasculares (CNIC) & Fundacion Jimenez Díaz University Hospital (IIS-FJD)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noemi Escalera, PT

CONTACT

+34 91 4531200 (ext 5401); noemi.escalera@cnic.es

Lucia Llanos, MD PhD

CONTACT

lucia.llanos@quironsalud.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized in a 2×2 factorial design. First, participants are assigned in a 1:1 ratio to a prasugrel-based or ticagrelor-based antiplatelet strategy. Second, participants are assigned in a 2:1 ratio to abbreviated dual antiplatelet therapy (DAPT) or standard 12-month DAPT. This design allows independent evaluation of DAPT duration and P2Y12 inhibitor strategy in patients with acute myocardial infarction after successful PCI.

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); ES (1); IE (1); NO (1); LA (1)