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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Vaestra Goetalandsregionen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

3 Dec 2021 → 26 Jun 2025

Decision date (initial)

2024-06-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-514224-17-00

EudraCT number

2021-000823-11

ClinicalTrials.gov

NCT05149560

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

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

Conditions and MedDRA coding

Myocardial infarction

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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. 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).
5. Subject has signed and dated the informed consent form.

Exclusion criteria 19

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 6

1. 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)
2. Definite or probable stent thrombosis or spontaneous target vessel myocardial infarction (time-to-event)
3. Any spontaneous myocardial infarction (time-to-event)
4. All-cause mortality (time-to-event)
5. The composite of cardiac death, spontaneous target vessel myocardial infarction or definite or probable stent thrombosis within 12 months.
6. Platelet reactivity as assessed by the ADP-test (multiplate), at 24 hours and 3 months.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vaestra Goetalandsregionen

Sponsor organisation

Vaestra Goetalandsregionen

Address

Regionens Hus

City

Vänersborg

Postcode

462 80

Country

Sweden

Scientific contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Oskar Angerås

Public contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Oskar Angerås

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications