Low-Density Lipoprotein Cholesterol-targeting Statin Therapy Versus the Intensity-based Statin Therapy in Patients With Coronary Artery Disease (LODESTAR)

Yonsei University

Status and phase: Active, not recruiting; Phase 4

Conditions: Coronary Artery Diseasse

Treatments: Drug: targeted LDL-C goal statin; Drug: fixed high potent statin therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02579499

4-2015-0713

Details and patient eligibility

About

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).

Enrollment: 4,400 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

4,400 participants in 2 patient groups

Fixed high-potent statin group

Active Comparator group

Description:

According to 2013 ACC/AHA guideline, patients will be received high-intensity statin therapy (atorvastatin 40mg or rosuvastatin 20mg) regardless of their baseline LDL-C levels.

Treatment:

Drug: fixed high potent statin therapy

Targeted LDL-C goal statin group

Experimental group

Description:

Patients will be tiltrated statin intensity guided by follow-up LDL-C level

Treatment:

Drug: targeted LDL-C goal statin