Comparing High- and Moderate-Intensity Atorvastatin Effects on Clopidogrel Platelet Reactivity

Comparing High- and Moderate-Intensity Atorvastatin Effects on Clopidogrel Platelet Reactivity in Percutaneous Coronary Intervention: The CLOATO Randomized Crossover Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0010377

Enrollment

320

Registered

2025-04-03

Start date

2025-03-01

Completion date

Unknown

Last updated

2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Patients will be randomly assigned in a 1:1 ratio to either high-intensity atorvastatin (40-80 mg daily) or moderate-intensity atorvastatin (10-20 mg daily) for 1 month. After this period, part

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The following criteria must be met to consider enrolling a subject in this study: 1. Individuals aged 19 years or older. 2. Individuals who have undergone percutaneous coronary intervention (PCI) with a second-generation drug-eluting stent for stable coronary artery disease or non-3. ST-segment elevation acute coronary syndrome (NSTE-ACS). 4. Individuals planned to use dual antiplatelet therapy, including aspirin 100 mg QD and clopidogrel 75 mg QD, for at least 3 months. Individuals who have provided a signed informed consent form.

Exclusion criteria

Exclusion criteria: Subjects meeting any of the following criteria are excluded from participation in this study: 1. Concurrent use of other lipid-lowering agents such as fibrates or omega-3 fatty acids. 2. Contraindications to statin or clopidogrel therapy. 3. Platelet function disorders or platelet counts <100,000/ml. 4. Active bleeding, recent (<1 month) bleeding tendency, or hemoglobin <10 g/dl. 5. Requirement for antiplatelet agents or anticoagulants other than aspirin and clopidogrel. 6. Active liver disease or liver cirrhosis. 7. Unexplained elevation of transaminases (greater than 2 times the upper limit of normal). 8. Peripheral muscle disease or creatine kinase levels exceeding 2.5 times the upper limit of normal. 9. Use of omeprazole, erythromycin, antifungal agents, or cyclosporine. 10. Acute renal failure or end-stage renal disease requiring dialysis. 11. Pregnant women or those with the potential to become pregnant during the study period. 12. Life expectancy of less than one year. 13. Clinically significant medical history deemed unsuitable for study participation by the investigator. 14. Any other reason deemed inappropriate for study participation by the investigator.

Design outcomes

Primary

Measure	Time frame
platelet reactivity unit (PRU)	—

Secondary

Measure	Time frame
Change of PRU;Rate of non-responder;LDL-cholesterol level;Rate of target LDL-cholesterol achievement	—

Countries

Korea, Republic of

Contacts

Public ContactYoung Jin Youn

Yonsei University, Wonju Severance Christian Hospital

younyj@yonsei.ac.kr+82-33-741-0916

Outcome results