NCT05149560

Ticagrelor Monotherapy After Stenting

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Ticagrelor 90mg	All patients will be prescribed ticagrelor as monotherapy

Timeline

• Start date: 2021-12-14
• Primary completion: 2025-06-26
• Completion: 2025-06-26
• First posted: 2021-12-08
• Last updated: 2026-03-20

Locations

1 site across 1 country: Sweden