Ticagrelor treatment after heart stenting

Ticagrelor Monotherapy After Coronary Stenting in Patients With Acute Myocardial Infarction - A Prospective Single-centre, Single-arm Phase II Study

This study is testing if taking ticagrelor alone is safe for people who have had heart stents placed after a heart attack.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vastra Gotaland Region (other gov)
• Locations: 1 site (Gothenburg)
• Trial ID: NCT05149560 on ClinicalTrials.gov

What this trial studies

This pilot study aims to evaluate the safety of ticagrelor monotherapy in patients who have undergone coronary artery stenting due to acute myocardial infarction. It will involve 200 participants who will receive invasive coronary angiography and percutaneous coronary intervention (PCI) guided by optical coherence tomography. The primary endpoint is a composite of cardiac death, spontaneous myocardial infarction, or stent thrombosis within three months. Patients will be monitored for one year, with a Data Safety Monitoring Board overseeing the outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have undergone coronary stenting for NSTEMI or STEMI.

Not a fit: Patients requiring chronic anticoagulant therapy or those with a history of stent thrombosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer alternative to dual antiplatelet therapy for patients after coronary stenting.

How similar studies have performed: While similar studies have explored antiplatelet therapies, this specific approach with ticagrelor monotherapy is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Men or women at least 18 years old.
2. Pre- or intra-procedure treatment with ticagrelor.
3. Coronary stenting with an everolimus-eluting stent (EES) due to NSTEMI or STEMI, with post-procedure diameter stenosis \<50% and post-procedure Thrombolysis In Myocardial Infarcton (TIMI) flow grade 3.
4. PCI guided by optical coherence tomography (OCT) with MLDMAX workflow
5. Subject has not yet received any post-procedure dose of aspirin or any post-procedure dose of a different P2Y12 inhibitor than ticagrelor (loading dose or pre-PCI maintenance dose of aspirin and/or a different P2Y12 inhibitor is allowed)
6. Subject has signed and dated the informed consent form.

Exclusion Criteria:

1. Planned PCI or any planned surgical intervention within the next 6 months.
2. Any indication for chronic anticoagulant therapy
3. Positive COVID-19 antigen or PCR test regardless of symptoms
4. History of definite stent thrombosis
5. Left main coronary artery stenting.
6. Stent thrombosis/restenosis as a culprit lesion.
7. Visible thrombus on angiography after PCI
8. Usage of glycoprotein IIb/IIIa inhibitors
9. Any bifurcation lesion with stenting of both branches.
10. Any treated lesion within an arterial or venous graft.
11. Any additional lesion(s) that need(s) a staged revascularization.
12. Known ejection fraction \<30%.
13. Known severe renal insufficiency (eGFR \<30 ml/min/1.72 m2).
14. Any life-threatening conditions or medical comorbidity resulting in life expectancy \< 12 months.
15. Participation in any investigational study that has not yet reached its primary endpoint, and for which monotherapy with ticagrelor may affect the primary outcome (as per the judgement of the investigator).
16. Patients who medicate with a potent CYP3A4 inhibitor (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir)
17. Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception.
18. Expected inability (by the investigator) to comply with the protocol
19. Subjects incapable to giving consent personally

Where this trial is running

Gothenburg

• Kardiologen — Gothenburg, Sweden (RECRUITING)

Study contacts

• Principal investigator: Oskar Angerås, MD, PhD — Sahlgrenska Universitetssjukhus
• Study coordinator: Oskar Angerås, MD, PhD

Conditions: Acute Myocardial Infarction