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

NCT02579499 Phase 4 UNKNOWN

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).

Details

Lead sponsor	Yonsei University
Phase	Phase 4
Status	UNKNOWN
Enrolment	4400
Start date	2016-09-09
Completion	2022-11

Conditions

• Coronary Artery Diseasse

Interventions

• fixed high potent statin therapy
• targeted LDL-C goal statin

Primary outcomes

• Major adverse cardiac and cerebrovascular events (MACCE) — 3 years

Countries

South Korea