Ticagrelor Monotherapy After Stenting (TIMO)

Ticagrelor Monotherapy After Coronary Stenting in Patients With Acute Myocardial Infarction - A Prospective Single-centre, Single-arm Phase II Study

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.

Study Overview

• Status: Completed
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Drug: Ticagrelor 90mg

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 41345
    • Kardiologen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ticagrelor; Ticagrelor 90 mg twice daily for 12 months	Drug: Ticagrelor 90mg; All patients will be prescribed ticagrelor as monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac event	The composite of cardiac death, spontaneous myocardial infarction or definite or probable stent thrombosis.	within 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with bleeding	Bleeding Academic Research Consortium (BARC) types 3 or 5 bleeding (time-to-event)	within 12 months
Number of Participants with stent thrombosis or target vessel myocardial infarction	Definite or probable stent thrombosis or spontaneous target vessel myocardial infarction (time-to-event)	within 12 months
Number of Participants with myocardial infarction	Any spontaneous myocardial infarction (time-to-event)	within 12 months
Number of Participants that died	All-cause mortality (time-to-event)	within 12 months
Number of Participants with major adverse cardiac event	The composite of cardiac death, spontaneous target vessel myocardial infarction or definite or probable stent thrombosis	within 12 months.
Platelet reactivity	Platelet reactivity as assessed by the ADP-test (multiplate).	at 24 hours
Platelet reactivity	Platelet reactivity as assessed by the ADP-test (multiplate)	at 3 months

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Collaborators: Sahlgrenska University Hospital
• Investigators: Principal Investigator: Oskar Angerås, MD, PhD, Sahlgrenska Universitetssjukhus

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2021
• Primary Completion (Actual): June 26, 2025
• Study Completion (Actual): June 26, 2025

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; Myocardial Infarction; Infarction; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleic Acids, Nucleotides, and Nucleosides; Purines; Nucleosides; Ribonucleosides; Adenosine; Purine Nucleosides; Ticagrelor
• Other Study ID Numbers: EudraCT number: 2021-000823-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No