Low-Density Lipoprotein Cholesterol-targeting Statin Therapy Versus the Intensity-based Statin Therapy in Patients With Coronary Artery Disease
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).
Timeline
- Start
- 2016-09-09
- Primary completion
- 2022-11
- Completion
- 2022-11
Publications
- Hong SJ, Lee YJ, Kang WC, Hong BK, Lee JY, Lee JB, Yang TH, Yoon J, Lee SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK; LODESTAR investigators. Effect of rosuvastatin versus atorvastatin on new-onset diabetes mellitus in patients treated with high-intensity statin therapy for coronary artery disease: a post-hoc analysis from the LODESTAR randomized clinical trial. Cardiovasc Diabetol. 2024 Aug 7;23(1):287. doi: 10.1186/s12933-024-02386-w.
- Lee SJ, Lee JB, Yang TH, Kang WC, Lee JY, Lee YJ, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Hong BK, Choi D, Yoon J, Jang Y, Hong MK; LODESTAR investigators. Treat-to-target or high-intensity statin treatment in older adults with coronary artery disease: a post hoc analysis of the LODESTAR trial. Age Ageing. 2024 Jul 2;53(7):afae132. doi: 10.1093/ageing/afae132.
- Lee YJ, Hong SJ, Kang WC, Hong BK, Lee JY, Lee JB, Cho HJ, Yoon J, Lee SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK; LODESTAR investigators. Rosuvastatin versus atorvastatin treatment in adults with coronary artery disease: secondary analysis of the randomised LODESTAR trial. BMJ. 2023 Oct 18;383:e075837. doi: 10.1136/bmj-2023-075837.
- Lee SJ, Kang WC, Lee JY, Lee JB, Yang TH, Yoon J, Lee YJ, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Hong BK, Jang Y, Hong MK; LODESTAR Investigators. Treat-to-target versus high-intensity statin treatment in patients with or without diabetes mellitus: a pre-specified analysis from the LODESTAR trial. EClinicalMedicine. 2023 Sep 20;64:102227. doi: 10.1016/j.eclinm.2023.102227. eCollection 2023 Oct.
- Hong SJ, Lee YJ, Lee SJ, Hong BK, Kang WC, Lee JY, Lee JB, Yang TH, Yoon J, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK; LODESTAR Investigators. Treat-to-Target or High-Intensity Statin in Patients With Coronary Artery Disease: A Randomized Clinical Trial. JAMA. 2023 Apr 4;329(13):1078-1087. doi: 10.1001/jama.2023.2487.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Atorvastatin | Small molecule | 20 mg | — |
| Comparator | Atorvastatin | Small molecule | 40 mg | — |
| Comparator | Rosuvastatin | Small molecule | 10 mg | — |
| Comparator | Rosuvastatin | Small molecule | 20 mg | — |