Could a shorter course of blood thinners be safer after a heart attack?
NCT ID NCT05491200
First seen Jul 02, 2026 · Last updated Jul 02, 2026
Summary
This study looks at people who have had a severe type of heart attack called STEMI. It compares a shorter course (about one month) of two blood thinners followed by just one drug (prasugrel) for a year, versus the standard one-year regimen of two blood thinners. The goal is to see if the shorter approach reduces bleeding complications while still preventing another heart attack or stroke. Some participants also receive either OCT-guided or angiography-guided stent placement to see which imaging method leads to better outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- prasugrel
- What this could lead to
- If successful, this could allow heart attack patients to take blood thinners for a shorter time, reducing bleeding risk while still preventing clots.
- What could go wrong
- This is a single trial with 1656 participants; results may not apply to all patients. Shorter therapy could increase the risk of heart attack or stroke in some individuals.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 1,656 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2022
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Eligibility at index procedure All STEMI patients who are planned to be treated with PCI: ST segment elevation myocardial infarction Chest discomfort suggestive of cardiac ischemia ≥20 min at rest with 1 of the following ECG features: * ST segment elevation ≥2 contiguous ECG leads * new or presumably new left bundle branch block In patients with multivessel disease, treatment only of the culprit lesion / target vessel during primary PCI is recommended. Eligibility at 30-45 days * All patients who have provided informed consent * Compliance to DAPT with no regimen modifications (Non-adherence Academic Research Consortium 0) * No occurrence of significant event (such as MI, unplanned revascularisation, stent thrombosis, stroke, major vascular complication/bleeding BARC Types 3 or greater). * Successful revascularization: - Successful delivery and deployment of the Study device(s), with final residual stenosis of \<30% (visually) for all target lesions. * Complete revascularization performed when more than 1 significant lesion, during the index procedure or in staged procedure(s) occurring within 15 days from the index procedure. Physiologic assessment highly recommended for lesions with stenosis between 50% and 90%. Exclusion criteria * Patients on oral anticoagulation * Contraindication to P2Y12 inhibitors and/or to Cardioaspirin or to any of the excipients (hypersensitivity, history of any stroke or transient ischemic attack within the last 12 months, active bleeding or haemorrhagic diathesis, fibrin-specific fibrinolytic therapy less than 24 h before randomization, severe hepatic dysfunction (Child-Pugh C), history of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines, history of gastrointestinal perforation or acute gastrointestinal ulcers, severe cardiac failure (NYHA grade III or IV), combination with methotrexate at doses of 15 mg/week or more). * Patients who have received P2Y12 inhibitors other than Prasugrel in the ambulance (Ticagrelor or Clopidogrel loading dose) or are already on P2Y12 inhibitors, may be enrolled in the protocol, provided that the Prasugrel loading dose is administered at admission, according to current guidelines recommendations (see section 5.2.2). * Concomitant oral or i.v. therapy with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice \>1L/day), CYP3A substrates with narrow therapeutic indices (e.g., cyclosporine, quinidine), or strong CYP3A inducers (e.g., rifampin), - rifampicin, phenytoin, carbamazepine, dexamethason, phenobarbital * Platelet count \<100.000/μL at the time of screening * Anemia (hemoglobin \<10 g/dL) at the time of screening * Comorbidities associated with life expectancy \<1 year * Pregnancy, giving birth within the last 90 days, or lactation (see appendix III for women of childbearing potential) * PCI indication for stent thrombosis or previous history of definite stent thrombosis * Non-deferrable major surgery on DAPT after PCI * Cardiogenic shock * Out of hospital cardiac arrest (OHCA) unless survivors of ventricular arrythmia with prompt return of spontaneous circulation (ROSC) * Patients with severe renal impairment: creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR). * Patients participating in another interventional (device of drug trial) within the previous 12 months or patients to whom an investigational drug was administered in the 30 days prior to screening, or 5 half-lives of the study drug, whichever is longer. * No informed consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
27 sites in 6 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AZ Delta
RECRUITINGRoeselare, Belgium
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AZ St.Jan
RECRUITINGBruges, Belgium
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Albert Schweitzer ziekenhuis
RECRUITINGDordrecht, Netherlands
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Amphia Ziekenhuis
RECRUITINGBreda, 4818 CK, Netherlands
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Asklepios Klinik Bad Oldesloe
RECRUITINGBad Oldesloe, Germany
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Catherina ziekenhuis
RECRUITINGEindhoven, Netherlands
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Centro Cardiologico Monzino IRCCS
RECRUITINGMilan, Italy
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Charles University Hospital
NOT_YET_RECRUITINGPrague, Czechia
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Erasmus Medical Center
RECRUITINGRotterdam, Netherlands
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FN BRNO
RECRUITINGBrno, Czechia
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Haga hospital
RECRUITINGThe Hague, Netherlands
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Imelda Bonheiden
RECRUITINGBonheiden, Belgium
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Institute for CVD Dedinje
RECRUITINGBelgrade, Serbia
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Institute for CVD Vojvodine
RECRUITINGKamenitz, Serbia
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Maasstadziekenhuis
RECRUITINGRotterdam, Netherlands
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Masaryk Hospital Usti nad Labem -
RECRUITINGHradec Králové, Czechia
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Ospedale Papa Giovanni XXIII
RECRUITINGBergamo, Italy
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RadboudUMC
RECRUITINGNijmegen, Netherlands
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Segeberger Kliniken
RECRUITINGBad Segeberg, Germany
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UZ Leuven
RECRUITINGLeuven, Belgium
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University Federico II
RECRUITINGNaples, Italy
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University Gemelli
RECRUITINGRoma, Italy
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University San Martino
RECRUITINGGenova, Italy
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University clinical center of Serbia
RECRUITINGBelgrade, Serbia
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University hospital Dresden
RECRUITINGDresden, Germany
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University of Ferrara
RECRUITINGFerrara, Italy
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ZOL Genk
RECRUITINGGenk, Belgium
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