Ticagrelor monotherapy after coronary stenting in patients with acute myocardial infarction - A prospective single-centre, single-arm phase II study

Phase 2

Active, not recruiting

Conditions: Myocardial infarction

Registration Number: 2024-514224-17-00

Lead Sponsor: Vaestra Goetalandsregionen, Vaestra Goetalandsregionen

Brief Summary: A pilot study planned to evaluate initial safety of ticagrelor monotherapy after coronary stenting due to acute myocardial infarction.

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruitment ended

Sex: Not specified

Target Recruitment: 200

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.

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 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
The composite of cardiac death, spontaneous myocardial infarction or definite or probable stent thrombosis within 3 months.		The composite of cardiac death, spontaneous myocardial infarction or definite or probable stent thrombosis within 3 months.

Secondary Outcome Measures

Name	Time	Method
Time to the following outcomes at 3- and 12 months (unless specified): Bleeding Academic Research Consortium (BARC) types 3 or 5 bleeding (time-to-event)		Time to the following outcomes at 3- and 12 months (unless specified): Bleeding Academic Research Consortium (BARC) types 3 or 5 bleeding (time-to-event)
Definite or probable stent thrombosis or spontaneous target vessel myocardial infarction (time-to-event)		Definite or probable stent thrombosis or spontaneous target vessel myocardial infarction (time-to-event)
Any spontaneous myocardial infarction (time-to-event)		Any spontaneous myocardial infarction (time-to-event)
All-cause mortality (time-to-event)		All-cause mortality (time-to-event)
The composite of cardiac death, spontaneous target vessel myocardial infarction or definite or probable stent thrombosis within 12 months.		The composite of cardiac death, spontaneous target vessel myocardial infarction or definite or probable stent thrombosis within 12 months.
Platelet reactivity as assessed by the ADP-test (multiplate), at 24 hours and 3 months.		Platelet reactivity as assessed by the ADP-test (multiplate), at 24 hours and 3 months.

Trial Locations

Locations (1): Sahlgrenska University Hospital-Vaestra Goetalandsregionen
🇸🇪
Goteborg, Sweden
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
🇸🇪Goteborg, Sweden
Oskar Angerås
Site contact
+46313427584
oskar.angeras@vgregion.se