Ticagrelor monotherapy after coronary stenting in patients with acute myocardial infarction - A prospective single-centre, single-arm phase II study
- Conditions
- Myocardial infarctionMedDRA version: 20.0Level: PTClassification code: 10000891Term: Acute myocardial infarction Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2024-514224-17-00
- Lead Sponsor
- Vaestra Goetalandsregionen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
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., 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.
Planned PCI or any planned surgical intervention within the next 6 months., Any treated lesion within an arterial or venous graft., Any additional lesion(s) that need(s) a staged revascularization., Known ejection fraction <30%., Known severe renal insufficiency (eGFR <30 ml/min/1.72 m2)., Any life-threatening conditions or medical comorbidity resulting in life expectancy < 12 months., 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)., Patients who medicate with a potent CYP3A4 inhibitor (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir), Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception., Expected inability (by the investigator) to comply with the protocol, Subjects incapable to giving consent personally, 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., Visible thrombus on angiography after PCI., Usage of glycoprotein IIb/IIIa inhibitors., Any bifurcation lesion with stenting of both branches.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method