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)
1 other identifier
observational
1,563
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 7, 2023
CompletedFirst Submitted
Initial submission to the registry
July 16, 2025
CompletedFirst Posted
Study publicly available on registry
July 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJuly 24, 2025
July 1, 2025
2.5 years
July 16, 2025
July 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of participants who meet the treatment goals for BP and LDL-C
From enrollment to the end of treatment at 24 weeks
Eligibility Criteria
A patient population with a history of undergoing PCI
You may qualify if:
- \. Adults aged 19 years and older, both male and female. 2. Patients who have undergone percutaneous coronary intervention (PCI) and are receiving antihypertensive and dyslipidemia-related medications.
- \. Individuals who require the administration of the investigational product based on the investigator's medical judgment in accordance with approved indications.
- \. Individuals who can understand the information provided to them and are able to voluntarily sign the informed consent form.
You may not qualify if:
- \. Individuals who fall under the contraindications for administration according to the approved indications of the investigational product.
- \. Individuals who have a history of receiving the investigational product prior to participation in this study.
- \. Individuals whom the investigator deems unsuitable for participation in this observational study for any other reason.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GC Biopharma
Yŏngin, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2025
First Posted
July 24, 2025
Study Start
June 7, 2023
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
July 24, 2025
Record last verified: 2025-07