Clinical trial NCT05149560: Ticagrelor Monotherapy After Stenting
Official title: Ticagrelor Monotherapy After Coronary Stenting in Patients With Acute Myocardial Infarction - A Prospective Single-centre, Single-arm Phase II Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Myocardial Infarction
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Sahlgrenska University Hospital
First posted: 2021-12-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-centre, single-arm, prospective phase II study
Primary purpose: TREATMENT

Brief 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.

Detailed description: A pilot study with 200 subjects undergoing coronary stenting due to NSTEMI or STEMI.

All patients will undergo invasive coronary angiography and clinically indicated Percutaneous Coronary Intervention (PCI). PCI will be performed using EES and OCT guidance using the MLDMAX algorithm (Morphology, Length, Diameter, Medial dissection, Apposition, Xpansion). Eligibility criteria will be assessed after completion of PCI.

Patients will be given a drug diary to document and as a reminder of the twice daily ticagrelor administration.

The Data Safety Monitoring Board (DSMB) will continuously review the outcomes for these patients. After the first 50 patients have been recruited and at least 30 of these patients have reached 3-month follow-up or had the primary outcome, the DSMB will convene to decide whether it is safe to proceed with the study. However, the DSMB will strongly consider early termination of the trial if more than 10 primary endpoint events occur.

Patients may be treated with aspirin prior to coronary angiography, as per local treatment guidelines. All patients will be followed for 1 year. After one year, all patients will be treated per the discretion of the treating physician.

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

Primary outcomes:
measure: Major adverse cardiac event
timeFrame: within 3 months
Secondary outcomes:
measure: Number of Participants with bleeding
timeFrame: within 12 months
measure: Number of Participants with stent thrombosis or target vessel myocardial infarction
timeFrame: within 12 months
measure: Number of Participants with myocardial infarction
timeFrame: within 12 months
measure: Number of Participants that died
timeFrame: within 12 months
measure: Number of Participants with major adverse cardiac event
timeFrame: within 12 months.
measure: Platelet reactivity
timeFrame: at 24 hours
measure: Platelet reactivity
timeFrame: at 3 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Kardiologen
Study officials:
affiliation: Sahlgrenska Universitetssjukhus
name: Oskar Angerås, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: