STEMI Treated With a Polymer-free Sirolimus-coated Stent and P2Y12 Inhibitor-based SAPT Versus Conventional DAPT

NCT05785897 | Recruiting DMC

• 1 other identifier: 2023-0309
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 2

Brief Summary

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. Accordingly, the use of newer-generation DES over BMS is currently recommended by the most recent guidelines. Vessel healing at the culprit site after DES implantation is however substantially delayed in patients with acute STEMI as compared to those with chronic coronary syndromes and is associated with a long-term risk for recurrent stent-related adverse clinical outcomes. These findings highlight the need for future iterations in modern DES technology to further improve clinical outcomes following PCI in this highest-risk patient subset. Current guidelines recommend dual antiplatelet therapy (DAPT) consisting of aspirin and a potent P2Y12 receptor inhibitor for 12 months after primary PCI for STEMI, unless there are contraindications such as excessive risk of bleeding. A recent meta-analysis of five large-scale randomized clinical trials including a total of 32'145 patients, of whom 4,070 (12.7%) patients were treated for STEMI, indicated that 1-3 months of DAPT followed by P2Y12 inhibitor-based single antiplatelet therapy (SAPT) after second-generation DES implantation in patients with chronic and acute coronary syndromes was associated with lower risk for major bleeding and similar risk for stent thrombosis, all-cause death, myocardial infarction, and stroke compared with conventional DAPT. These findings suggest that a potent P2Y12 inhibitor-based SAPT following a short DAPT course (1-3 months) may represent a preferable treatment option, which is associated with similar ischemic, but lower bleeding risk, for patients undergoing PCI with newer-generation DES compared to standard conventional 12 months DAPT. The question of whether SAPT using a potent oral P2Y12 inhibitor (ticagrelor or prasugrel) without aspirin (aspirin-free strategy) after primary PCI with a newest-generation thin-strut polymer-free drug-eluting stent is safe and effective compared to a conventional guideline-recommended 6- to 12-month DAPT course among patients with STEMI remains uncertain.

Conditions

ST Elevation Myocardial Infarction

Keywords

Single antiplatelet therapy; P2Y12 receptor inhibitor; ST-segment elevation myocardial infarction; Polymer-free drug-eluting stent

Outcome Measures

Primary Outcomes (2)

• Rate of major adverse cardiac and cerebrovascular events (MACCE)

  Composite of all-cause death, non-fatal myocardial re-infarction, non-fatal stroke, urgent target vessel revascularization (PCI, or CABG), or Academic Research Consortium (ARC) definite/probable stent thrombosis

  12 months

• Rate of BARC class 3 or 5 major bleeding

  Bleeding Academic Research Consortium (BARC) criteria

  12 months

Secondary Outcomes (9)

• Rate of any death

  12 months

• Rate of any non-fatal myocardial re-infarction

  12 months

• Rate of any revascularization

  12 months

• Rate of patient-oriented cardiac outcome (POCE)

  12 months

• Rate of target lesion failure (TLF)

  12 months

Study Arms (2)

Potent P2Y12 receptor inhibitor-based single antiplatelet therapy (SAPT)

EXPERIMENTAL

* P2Y12 receptor inhibitor-based SAPT with ticagrelor (90 mg bd) or prasugrel (10 mg od, or 5 mg in patients ≥75 years or with a body weight \<60 kg), at the discretion of the investigator, during 12 months after the index procedure. * Clopidogrel-based SAPT will not be allowed. * Aspirin will be discontinued after primary PCI, or at latest at hospital discharge.

Device: Successful primary PCI, defined as primary PCI of the culprit lesion with ≥1 Abluminus NP polymer-free sirolimus-based nanocarrier eluting stent (Concept Medical Inc., India) implantation

Conventional dual antiplatelet therapy (DAPT)

ACTIVE COMPARATOR

* DAPT combining aspirin (≥75 mg od) and a potent P2Y12 receptor inhibitor, either ticagrelor (90 mg bd) or prasugrel (10 mg od, or 5 mg in patients ≥75 years or with a body weight \<60 kg), at the discretion of the investigator, during 6 or 12 months after the index procedure, followed by aspirin-based SAPT. * Clopidogrel (75 mg od orally) will be allowed if ticagrelor or prasugrel are contra-indicated or not available.

Device: Successful primary PCI, defined as primary PCI of the culprit lesion with ≥1 Abluminus NP polymer-free sirolimus-based nanocarrier eluting stent (Concept Medical Inc., India) implantation

Interventions

Successful primary PCI, defined as primary PCI of the culprit lesion with ≥1 Abluminus NP polymer-free sirolimus-based nanocarrier eluting stent (Concept Medical Inc., India) implantation DEVICE

'All-comer' subjects with acute STEMI undergoing primary PCI according to current ESC guidelines will be eligible. Eligible subjects will be pre-treated with DAPT consisting of aspirin (loading dose: 150-300 mg orally or 80-500 mg intravenously, maintenance dose: 75-100 mg daily orally) and a potent P2Y12 receptor inhibitor, either ticagrelor (loading dose: 180 mg orally, maintenance dose: 90 mg bd orally) or prasugrel (loading dose: 60 mg orally, maintenance dose: 10 mg od orally or 5 mg od orally if age \>75 years or weight \<60 kg) at the time of STEMI diagnosis, or at the very latest at the time of primary PCI. Successful primary PCI, defined as primary PCI of the culprit lesion with ≥1 Abluminus NP polymer-free sirolimus-based nanocarrier eluting stent (Concept Medical Inc., India) implantation and final residual stenosis \<30% by visual estimation or 20% by QCA.

Also known as: 'All-comer' subjects with acute STEMI undergoing primary PCI according to current ESC guidelines will be eligible., Pre-treatment with DAPT consisting of aspirin and a potent P2Y12 receptor inhibitor, either Ticagrelor or Prasugrel at the time of STEMI diagnosis, or at the very latest at the time of primary PCI

Conventional dual antiplatelet therapy (DAPT); Potent P2Y12 receptor inhibitor-based single antiplatelet therapy (SAPT)

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years.
• Subjects 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 time of primary PCI.
• Subjects 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 Abluminus NP polymer-free sirolimus-based nanocarrier eluting stent (Concept Medical Inc., India) implantation, and final residual stenosis \<30% by visual estimation or 20% by quantitative coronary angiography (QCA) \[38\].
• Subject willing to participate and able to understand, read and sign the informed consent form.

You may not qualify 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.
• Planned non-cardiac surgery that cannot be postponed for at least 6 months.
• Participation or planned participation in another interventional clinical trial.
• Life expectancy \<1 years.
• Pregnancy.
• Unwillingness or inability (e.g. physical or cognitive) to comply with study procedure, medication adherence and schedule.

Sponsors & Collaborators

• Clinical Trials Unit University of Bern: collaborator
• IGLESIAS Juan Fernando: lead

Study Sites (2)

Geneva University Hospitals

Geneva, Canton of Geneva, 1205, Switzerland

RECRUITING

Zurich University Hospital

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

• Juan F. Iglesias, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Véronique Menoni, Study coordinator

CONTACT

+41795530516; veronique.menoni@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 11, 2023
• First Posted: March 27, 2023
• Study Start: November 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

CH (2)