Comparing the Intensity-based statin therapy with attained low-density lipoprotein cholesterol based statin therapy in patients with coronary artery disease: Statin Strategy Proposal trial

Not Applicable

Completed

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0002939
• Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-10-27
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 4400

Inclusion Criteria

Patients = 19 years old
- Patients clinically diagnosed with coronary artery disease including stable angina, unstable angina, acute non-ST elevation myocardial infarction and acute ST elevation myocardial infarction
- Patients with signed informed consent

Exclusion Criteria

- Pregnant women or women with potential childbearing
- Patients severe adverse events or hypersensitive to statin or patients with multi-drug allergy.
- Who had received drug that have a drug interaction with statin (strong inhibitor of cytochrome p-450 3A4 or 2C9)
- Patients with risk factors for myopathy with hereditary muscle disorder, hypothyroidism, alcohol use disorder, severe hepatic dysfunction (3 times normal reference values) or rhabdomyolysis
- Life expectancy < 3 years
- Patient with who can not be followed up for more than 1 year
- Patients who cannot understand or read the consent form

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac and Cerebrovascular Event (MACCE)

Secondary Outcome Measures

Name	Time	Method
The incidence of diabetes and the change of blood glucose control drugs in diabetic patients;Hospitalization due to heart failure;Deep vein thrombosis or Pulmonary thromboembolism;Percutaneous trans-luminal angioplasty on peripheral artery obstructive disease;Aortic intervention or operation;ESRD with renal replacement therapy;Discontinuation rate of statin;cataract surgery;Aminotransferase elevation: (ALT > 3 x ULN), Creatine kinase elevation: (CK>5 x ULN), Increase of creatinine (>50% from baseline)