Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using Optical Coherence Tomography(OCT)[LINK IT TWO]
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03657758|
Recruitment Status : Not yet recruiting
First Posted : September 5, 2018
Last Update Posted : September 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Angina Pectoris||Drug: EPA and rosuvastatin Drug: High dose rosuvastatin||Phase 4|
Eicosapentaenoic acid and statin therapy prevents cardiovascular events. However, the impact of these treatment in patients with in-stent neoatherosclerosis has not been clarified.
So, the investigators conducted LINK IT study. This study showed that eicosapentaenoic acid(EPA) and rosuvastatin therapy improve lipid index in patients compared with rosuvastatin alone therapy.
However, it was insufficient to directly evaluate the efficacy of additional effect of EPA for neoatherosclerosis. Because, statin dose of two groups was different and type of stent was variety.
Therefore, the investigators designed a new prospective, randomized OCT study. The OCT operators randomly assigned 75 patients who were detected neoatherosclerosis on follow-up OCT examination after implanted everolimus eluting stent to three groups; 5mg/day of rosuvastatin therapy (low dose statin therapy group) or 10mg/day of rosuvastatin therapy (high dose statin therapy group) or 10mg/day of rosuvastatin and 1800mg/day of eicosapentaenoic acid therapy (EPA and statin therapy group). Serial coronary angiography and OCT were performed at 9 months after baseline OCT procedure.
This study aim is to evaluate the additional effect of eicosapentaenoic acid and dose up effect of rosuvastatin for neoatherosclerosis in coronary artery disease patients by comparing 3 groups.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using OCT|
|Estimated Study Start Date :||September 17, 2018|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||August 31, 2021|
Active Comparator: EPA and statin therapy group
After randomization, patients with combination therapy start EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for ９ months.
Drug: EPA and rosuvastatin
To take EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for ９ months.
Active Comparator: High dose statin therapy group
After randomization, patients with high dose statin therapy start high dose rosuvastatin (10mg/day) for ９ months.
Drug: High dose rosuvastatin
To take high dose rosuvastatin (10mg/day) for ９ months.
No Intervention: low dose statin therapy group
After randomization, patients with low dose statin therapy take low dose rosuvastatin (5mg/day) for ９ months.
- The change in lipid index [ Time Frame: 9 months ]mean lipid arc ✕ lipid length
- MACE [ Time Frame: 9 months ]Major cerebro-cardiovascular events（Nonfatal stroke, Nonfatal myocardial infarction, cardiovascular death)
- The change in minimum lumen area [ Time Frame: 9 months ]OCT parameter
- The change in average neointimal thickness [ Time Frame: 9 months ]OCT parameter
- The change in lipid arc [ Time Frame: 9 months ]OCT parameter
- The change in lipid length [ Time Frame: 9 months ]OCT parameter
- The change in thin cap fibroatheroma [ Time Frame: 9 months ]OCT parameter
- The change in macrophage grade [ Time Frame: 9 months ]OCT parameter
- The change in plaque volume [ Time Frame: 9 months ]Near infrared spectroscopy intravascular ultrasound(NIRS-IVUS) parameter
- The change in max Lipid-core burden index [ Time Frame: 9 months ]NIRS-IVUS parameter
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657758
|Contact: Hiromasa Otake, ph.Demail@example.com|
|Kobe University Graduate School of Medicine, Department of Cardiology|
|Kobe, Hyogo, Japan, 650-0017|
|Contact: Hiromasa Otake, ph.D +81-78-382-5846 firstname.lastname@example.org|