Essential Hypertension With Stable Angina and Dyslipidemia Clinical Trial
Official title:
A Study to Evaluate the Effects of Azilsartan on Coronary Artery Plaque in Essential Hypertensive Patients With Stable Angina and Dyslipidemia.
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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment