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Compares treatment options for ST Elevation Myocardial Infarction
Official title STEMI Treated With a Polymer-free Sirolimus-coated Stent and P2Y12 Inhibitor-based SAPT Versus Conventional DAPT
ClinicalTrials.gov ID: NCT05785897
What this study is testing
- What it's testing
- Primary percutaneous coronary intervention (PCI) is the preferred revascularization strategy for patients with acute ST-segment elevation myocardial infarction (STEMI). Compared with bare-metal stents (BMS) and early-generation thick-strut polymer-based drug-eluting stents (DES), newer-generation DES with thinner strut stent platforms and durable or biodegradable polymers have been shown to improve long-term safety and efficacy outcomes among patients with STEMI.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years.
- people who have received DAPT consisting of aspirin and any of the commercially available P2Y12 receptor inhibitors (ticagrelor, prasugrel, or...
- people with ≥1 acute infarct artery target vessel with ≥1 coronary artery stenosis in a native coronary artery with diameter from 2.25 to 4.0 mm who...
- Subject willing to participate and able to understand, read and sign the informed consent form.
You likely can't join if
- Known allergy or intolerance to aspirin, ticagrelor, prasugrel, or sirolimus.
- Inability to adhere to DAPT for at least 6 months.
- Patient already on DAPT at index presentation due to recent PCI for chronic coronary syndrome (\<6 months) or ACS (\<12 months).
- Patient on chronic oral anticoagulation at index presentation.
- Patient with mechanical complication of STEMI.
- Patient with STEMI due to stent thrombosis.
See the full eligibility criteria
- Age ≥18 years.
- people who have received DAPT consisting of aspirin and any of the commercially available P2Y12 receptor inhibitors (ticagrelor, prasugrel, or clopidogrel) at the time of STEMI diagnosis, or at the very latest at the...
- people with ≥1 acute infarct artery target vessel with ≥1 coronary artery stenosis in a native coronary artery with diameter from 2.25 to 4.0 mm who underwent successful primary PCI, defined as primary PCI with ≥1...
- Subject willing to participate and able to understand, read and sign the informed consent form.
- Known allergy or intolerance to aspirin, ticagrelor, prasugrel, or sirolimus.
- Inability to adhere to DAPT for at least 6 months.
- Patient already on DAPT at index presentation due to recent PCI for chronic coronary syndrome (\<6 months) or ACS (\<12 months).
- Patient on chronic oral anticoagulation at index presentation.
- Patient with mechanical complication of STEMI.
- Patient with STEMI due to stent thrombosis.
- Planned non-cardiac surgery that cannot be postponed for at least 6 months.
- Participation or planned participation in another treatment clinical trial.
- Life expectancy \<1 years.
- Pregnancy.
- Unwillingness or inability (e.g. physical or cognitive) to comply with study procedure, medication adherence and schedule.
The study team makes the final eligibility decision.
Where it's taking place
- Geneva, Canton of Geneva, Switzerland
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Geneva, Canton of Geneva, Switzerland; Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.