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P24

Poster
A multicenter, open-label, randomized controlled clinical trial to assess the efficacy and safety of appropriate target values for lipid management in patients who have mild to moderate stenotic lesions with high-risk plaques in coronary arteries: Study protocol

M. Matsuda1, K. Hasegawa2 (1Kure, Hiroshima JP; 2Kyoto JP)


Aims

To investigate the efficacy of strict lipid management by secondary prevention high-risk criteria in preventing major cardiovascular events and progression of coronary artery stenosis in study subjects without proven history of coronary artery diseases (CAD) who have non-occlusive lesions with unstable plaques or severe calcification detected by coronary artery computed tomography (CACT), in comparison with standard lipid management as per the primary prevention criteria.

Design & Methods

This is a multicenter, open-label, randomized controlled parallel-group clinical study. Patients with mild-to-moderate stenotic lesions with positive remodeling or severe calcification, but without any history of CAD, will be randomly allocated to group A (reduce LDL-C to < 120~160 mg/dL according to the primary prevention criteria based on the Japanese Guideline for Prevention of Atherosclerotic Cardiovascular Diseases) and group B (reduce LDL-C to < 70 mg/dL according to the secondary prevention criteria at a high risk based on the Guideline). They will be strictly managed to achieve the LDL-C targets. We will follow-up and evaluate the composite endpoints consisting of major cardiovascular events (death from coronary artery disease, nonfatal myocardial infarction, operation for coronary revascularization, and stroke) and stenosis progression or new stenosis development for 3 years.

Conclusions

Our study will contribute to the development of a better preventive therapy for patients who have non-occlusive lesions with unstable plaques or severe calcification detected on CACT.

    
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Aims

To investigate the efficacy of strict lipid management by secondary prevention high-risk criteria in preventing major cardiovascular events and progression of coronary artery stenosis in study subjects without proven history of coronary artery diseases (CAD) who have non-occlusive lesions with unstable plaques or severe calcification detected by coronary artery computed tomography (CACT), in comparison with standard lipid management as per the primary prevention criteria.

Design & Methods

This is a multicenter, open-label, randomized controlled parallel-group clinical study. Patients with mild-to-moderate stenotic lesions with positive remodeling or severe calcification, but without any history of CAD, will be randomly allocated to group A (reduce LDL-C to < 120~160 mg/dL according to the primary prevention criteria based on the Japanese Guideline for Prevention of Atherosclerotic Cardiovascular Diseases) and group B (reduce LDL-C to < 70 mg/dL according to the secondary prevention criteria at a high risk based on the Guideline). They will be strictly managed to achieve the LDL-C targets. We will follow-up and evaluate the composite endpoints consisting of major cardiovascular events (death from coronary artery disease, nonfatal myocardial infarction, operation for coronary revascularization, and stroke) and stenosis progression or new stenosis development for 3 years.

Conclusions

Our study will contribute to the development of a better preventive therapy for patients who have non-occlusive lesions with unstable plaques or severe calcification detected on CACT.

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JP-737-0023 Kure, Hiroshima
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