The purpose of this study is to evaluate the effects of oral azilsartan once daily for 32 weeks on coronary artery plaque in essential hypertensive patients with stable angina and dyslipidemia.
The open-label design without a control group was selected because this clinical study primarily aims to explore the effects of azilsartan on coronary artery plaques. This study targeting patients with coronary artery plaque has been designed to enroll hypertensive patients with dyslipidemia. Also in light of the invasive nature of the major assessment procedures (i.e., IB-IVUS, OCT), this study will only enroll patients with stable angina planned to undergo percutaneous coronary intervention with stent placement, among patients with coronary artery plaque. The starting dose of azilsartan has been set to 20 mg on the basis of the usual clinical dose of the drug in patients with essential hypertension, and dose increase of azilsartan will be permitted only when the target blood pressure has not been achieved. The duration of treatment has been set to 32 weeks in line with clinical practice, in which coronary angiography is typically performed after a 32-week follow-up period following PCI with stent placement.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Azilsartan tablets
Unnamed facility
Tokushima, Japan
Change in percentage of the lipid pool in the coronary artery plaque
Change in percentage of the lipid pool in the coronary artery plaque from the start of the treatment period at the end of the treatment period (Week 32). Percentage of the lipid pool in the coronary artery plaque is measured by integrated backscatter intravascular ultrasound (IB-IVUS).
Time frame: 32 weeks
Change in volume of the coronary artery plaque
Change in the volume of the coronary artery plaque from the start of the treatment period to the end of the treatment period. Change from baseline in volume of the coronary artery plaque is measured by integrated backscatter intravascular ultrasound (IB-IVUS).
Time frame: 32 weeks
Change in percentage of the fibrotic component in the coronary artery plaque
Change in percentage of the fibrotic component in the coronary artery plaque from the start of the treatment period at the end of the treatment period (Week 32). Percentage of the fibrotic component in the coronary artery plaque is measured by integrated backscatter intravascular ultrasound (IB-IVUS).
Time frame: 32 weeks
Change in percentage of the calcified component in the coronary artery plaque
Change in percentage of the calcified component in the coronary artery plaque from the start of the treatment period at the end of the treatment period (Week 32). Percentage of the calcified component in the coronary artery plaque is measured by integrated backscatter intravascular ultrasound (IB-IVUS).
Time frame: 32 weeks
Change in number of microchannels
Change from baseline in number of microchannels is measured by Optical Coherence Tomography(OCT).
Time frame: 32 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in thickness of the fibrous cap
Change from baseline in number of microchannels is measured by Optical Coherence Tomography(OCT).
Time frame: 32 weeks