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NCT07507500
Dual Antiplatelet Therapy Strategies After Acute Myocardial Infarction Undergoing PCI: Prasugrel vs Ticagrelor & 12 Months vs 1-3 Months
Conditions: Myocardial Infarction (MI)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 8100
Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Location: Mater Private Network Dublin Dublin
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.
Eligibility Criteria
Inclusion Criteria:
* ≥18 years old
* Admitted because of an acute MI (either STEMI or NSTEMI).
* Invasive management during index admission with successful PCI.
* Able to consent.
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07507500). StuddyBuddy aggregates publicly available trial information.