NCT07084246

Evaluation of the Effectiveness and Safety of Rozetel Tablet in Patients After PCI: A Multi-Center Observational Study

A Multi-center, Prospective, Non-intervention, Observational Study to Evaluate the Effectiveness and Safety of the Rozetel Tablet in Patients Who Had Undergone Percutaneous Coronary Intervention(PCI)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,563 (actual)
• Sponsor: GC Biopharma Corp · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effectiveness and safety of the investigational drug on blood pressure and LDL cholesterol control during the observation period in patients who have undergone percutaneous coronary intervention (PCI) in actual clinical practice.

Detailed description

This study is a multicenter, prospective, non-interventional observational study aimed at observing the efficacy and safety of the investigational product, a combination of telmisartan, rosuvastatin, and ezetimibe, in patients who have undergone percutaneous coronary intervention (PCI) for the control of blood pressure and lipid levels. In actual clinical practice, patients aged 19 years and older who have undergone PCI and are receiving antihypertensive and dyslipidemia-related medications based on approved indications will be assessed for eligibility after receiving an explanation of the study and providing written consent, as determined by the investigator's judgment regarding the need for the investigational product. Eligible participants according to the inclusion/exclusion criteria will receive the investigational product based on the approved indications (efficacy, dosage, precautions, etc.) after registration. Follow-up visits will be conducted at 24 weeks and 48 weeks (each ± 4 weeks) post-treatment to evaluate efficacy and safety. All treatments, including drug administration and laboratory tests performed after the administration of the investigational product, will be conducted according to the investigator's medical judgment, independent of the participant's involvement in the study, and information to be collected in this observational study will continue for up to 48 weeks (± 4 weeks).

Conditions

• Hypertension, Dyslipidemia

Timeline

• Start date: 2023-06-07
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-07-24
• Last updated: 2025-07-24

Locations

1 site across 1 country: South Korea