* Fimasartan will be more beneficial in stabilizing the plaque vulnerability compared to control group in deferred coronary lesions. * Fimasartan will be more beneficial in reducing total plaque volume compared to control group in deferred coronary lesions. * Fimasartan will be more beneficial in reducing functional impairment of stenotic lesions (assessed by FFR:Fractional Flow Reserve) in deferred coronary lesions.
Prospective, double-blind, randomized clinical study with enrollment of patients over at least 18 years of age who require coronary angiography for a clinical indication with hypertension defined as systolic blood pressure \>140mmHg or diastolic blood pressure \>90mmHg. Inclusion requires at least one deferred coronary lesion with 1) visually-estimated angiographic %diameter stenosis 20-50% or 2) %diameter stenosis \>50% without any evidence of inducible ischemia. The target vessel for IVUS interrogation must not have undergone angioplasty (deferred lesion) nor have more than 50% luminal narrowing throughout a target segment. Patients meeting inclusion criteria without any exclusion criteria will be randomized 1:1 (Fimasartan 60-120 mg vs placebo). All subjects will be followed up at 1 year for serial VH-IVUS and conventional IVUS evaluation. Also, OCT sub-study will be performed in selected patients with lesions at least 20 mm distally located from coronary ostium. All patients will be blindly assigned to control and Fimasartan once daily as 1:1 ratio and are prescribed for 1year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
186
60-120mg/day (target dose) of Fimasartan will be administered for the study period (till the follow-up angiography)
60-120mg/day (target dose) of Placebo will be administered for the study period (till the follow-up angiography)
Chonnam National University Hospital
Gwangju, South Korea
Asan Medical Center
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
Change in percent necrotic core (NC) volume of plaque by VH (Virtual Histology) in the "target segment" (within deferred vessel)
Time frame: baseline and 1 year
Change of total atheroma volume (TAV) and percent atheroma volume (PAV) of the target segment and the most diseased 10-mm segment (normalized to different segment length) with the largest plaque volume
Time frame: baseline and 1 year
Percent change in minimal lumen area (MLA) in target segment
Time frame: baseline and 1 year
Change of absolute area or percentages (%) of each plaque VH composition (fibrotic, fibrofatty, dense calcium, necrotic core) at minimal lumen area (MLA) and largest necrotic core area within the target segment
Time frame: baseline and 1 year
Change of VH-IVUS (Intra Vascular UltraSound) detected plaque type from baseline
Time frame: at 1 year
Change of percentage (%) of OCT (Optical Coherence Tomography)-defined TCFA (Thin Cap Fibrotic Atheroma) within the target segment from baseline
Time frame: at 1 year
Change of composition of OCT-defined fibrous, fibro-calcific, and lipid-rich plaque within the target segment
Time frame: baseline and 1 year
Change of OCT-defined fibrous cap thickness, the presence of plaque disruption, calcification or intraluminal thrombus within the target segment
Time frame: baseline and 1 year
Change of FFR in target segment from baseline
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Time frame: at 1 year
systolic and diastolic blood pressure
Time frame: at 1 year follow-up
Change in high sensitive CRP (C-Reactive Protein)from baseline
Time frame: at 1 year