Ticagrelor Monotherapy After Stenting

NCT05149560 | Completed Phase 2 DMC

• 1 other identifier: EudraCT number: 2021-000823-11
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac event

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

  within 3 months

Secondary Outcomes (7)

• Number of Participants with bleeding

  within 12 months

• Number of Participants with stent thrombosis or target vessel myocardial infarction

  within 12 months

• Number of Participants with myocardial infarction

  within 12 months

• Number of Participants that died

  within 12 months

• Number of Participants with major adverse cardiac event

  within 12 months.

Study Arms (1)

Ticagrelor

EXPERIMENTAL

Ticagrelor 90 mg twice daily for 12 months

Drug: Ticagrelor 90mg

Interventions

Ticagrelor 90mg DRUG

All patients will be prescribed ticagrelor as monotherapy

Ticagrelor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Kardiologen

Gothenburg, 41345, Sweden

Location

MeSH Terms

Interventions

Ticagrelor

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Oskar Angerås, MD, PhD

  Sahlgrenska Universitetssjukhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Single-centre, single-arm, prospective phase II study

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 8, 2021
• Study Start: December 14, 2021
• Primary Completion: June 26, 2025
• Study Completion: June 26, 2025
• Last Updated: March 20, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)