Low-Density Lipoprotein Cholesterol-targeting Statin Therapy Versus the Intensity-based Statin Therapy in Patients With Coronary Artery Disease: a Randomized Comparison Trial

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare clinical safety & efficacy of fixed-high potent statin therapy (according to 2013 ACC/AHA guideline) vs. targeted LDL-C goal statin therapy (LDL<70mg/dL) for secondary prevention. Total 4400 patients with coronary artery disease patients requiring statin treatment were categorized fixed high-potent statin group and targeted LDL-C group. The investigators will compare primary endpoint (major adverse cardiac and cerebrovascular event (MACCE)) and secondary endpoint (1. New onset diabetes mellitus after randomization, 2. Hospitalization due to heart failure, 3. Deep vein thrombosis or Pulmonary thromboembolism,

4. Percutaneous trans-luminal angioplasty on peripheral artery obstructive disease, 5. Aortic intervention or operation, 6. ESRD with renal replacement therapy).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Atorvastatin Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium

Criteria

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