Ticagrelor Monotherapy After Stenting (NCT05149560) | Clinical Trial Compass
CompletedPhase 2
Ticagrelor Monotherapy After Stenting
Sweden200 participantsStarted 2021-12-14
Plain-language summary
A pilot study planned to evaluate initial safety of ticagrelor monotherapy after coronary stenting due to acute myocardial infarction.
The study is a single-centre, single-arm, prospective phase II study 200 patients who undergo coronary artery stenting due to NSTEMI or STEMI will be included.
Primary endpoint (variable):
The composite of cardiac death, spontaneous myocardial infarction or definite or probable stent thrombosis within 3 months.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men or women at least 18 years old.
✓. Pre- or intra-procedure treatment with ticagrelor.
✓. 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.
✓. PCI guided by optical coherence tomography (OCT) with MLDMAX workflow
✓. 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)
✓. Subject has signed and dated the informed consent form.
Exclusion criteria
✕. Planned PCI or any planned surgical intervention within the next 6 months.
✕. Any indication for chronic anticoagulant therapy
✕. Positive COVID-19 antigen or PCR test regardless of symptoms
✕. History of definite stent thrombosis
✕. Left main coronary artery stenting.
✕. Stent thrombosis/restenosis as a culprit lesion.