NCT07507500 Dual Antiplatelet Therapy Strategies After Acute Myocardial Infarction Undergoing PCI: Prasugrel vs Ticagrelor & 12 Months vs 1-3 Months
| NCT ID | NCT07507500 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz |
| Condition | Myocardial Infarction (MI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 8,100 participants |
| Start Date | 2026-09-02 |
| Primary Completion | 2029-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 8,100 participants in total. It began in 2026-09-02 with a primary completion date of 2029-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Borja Ibanez, MD PhD
PRINCIPAL INVESTIGATOR
Centro Nacional de Investigaciones Cardiovasculares (CNIC) & Fundacion Jimenez Díaz University Hospital (IIS-FJD)
Frequently Asked Questions
Who can join the NCT07507500 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myocardial Infarction (MI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07507500 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07507500 currently recruiting?
Yes, NCT07507500 is actively recruiting participants. Contact the research team at noemi.escalera@cnic.es for enrollment information.
Where is the NCT07507500 trial being conducted?
This trial is being conducted at Dublin, Ireland, Riga, Latvia, Oslo, Norway, Krakow, Poland and 1 additional location.
Who is sponsoring the NCT07507500 clinical trial?
NCT07507500 is sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. The principal investigator is Borja Ibanez, MD PhD at Centro Nacional de Investigaciones Cardiovasculares (CNIC) & Fundacion Jimenez Díaz University Hospital (IIS-FJD). The trial plans to enroll 8,100 participants.