Ticagrelor Monotherapy After Stenting (TIMO)

  • STATUS
    Recruiting
  • End date
    Dec 15, 2024
  • participants needed
    200
  • sponsor
    Vastra Gotaland Region
Updated on 16 June 2022

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.

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.

Details
Condition Acute Myocardial Infarction
Treatment Ticagrelor 90mg
Clinical Study IdentifierNCT05149560
SponsorVastra Gotaland Region
Last Modified on16 June 2022

Eligibility

Yes No Not Sure

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
Visible thrombus on angiography after PCI
Usage of glycoprotein IIb/IIIa inhibitors
Any bifurcation lesion with stenting of both branches
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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