NCT06509893

Ticagrelore Alone Post PCI

A Single-center, Randomized, 6-month, Non-inferiority Study to Compare the Safety and Efficacy of TICAgreLor mONotherapy Versus Dual Antiplatelet Therapy in Chronic Coronary Syndrome Patients Post Percutaneous Coronary IntErvention (TICALONE)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5,400 (estimated)
• Sponsor: Shiraz University of Medical Sciences · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

After PCI for CCS patients, single center double blind randomization will be done and patients will receive aspirin 80 mg and clopidogrel 75 mg versus 90 mg two times daily of ticagrelor, for 6 months and MACE will be followed in registry of professor Kojuri cardiology clinic

Detailed description

An interventional cardiologist will perform angiography with the supervision of a fellow interventional cardiologist. Patients who need revascularization will undergo PCI using DES (Drug-eluting stent). PCI will be performed using the radial or femoral approach to achieve complete revascularization of at least one stenosis with a diameter of ≥50%. All target lesions will be revascularized using the 4th generation DES. Randomization (1:1) will take place after diagnostic angiography but before stent insertion (figure 1). Eligible patients will be divided into two groups: the reference group, which will get conventional DAPT with aspirin and Clopidogrel (80 mg aspirin once daily, and 75mg clopidogrel once daily), and the experimental group, which will receive ticagrelor monotherapy (90mg twice daily) following PCI for six months. Antiplatelet therapy will start before or at the time of PCI. Patients will receive a loading dose of assigned drugs (325mg for aspirin, 300mg for clopidogrel, and 180mg for ticagrelor) before stent insertion unless they are already on pre-PCI maintenance therapy with the mentioned drugs. Subjects are randomly assigned a treatment strategy by an interactive web response system. The primary efficacy endpoint is a composite of cardiac death, target vessel MI, stent thrombosis, and the need for revascularization occurring within 6 months of PCI. The secondary endpoints are all-cause death, occurrence of MACE including stroke (ischemic, hemorrhagic, or unknown), MI, arrhythmia, and each component of the primary endpoint at 6 months. Safety is the third outcome

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	aspirin 80 mg and clopidogrel 75 mg daily	post PCI patients received these two drugs as dual antiplatelet regimen
DRUG	Ticagrelor 90 MG	Post PCI patients receive Ticagrelor 90 mg two times daily as single potent antiplatelet

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-12-01
• Completion: 2026-05-01
• First posted: 2024-07-19
• Last updated: 2025-05-21

Locations

2 sites across 1 country: Iran