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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
| Boryung Pharmaceutical Co., Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fimasartan | Experimental | Initial dose will be started with 60mg per day. At 4 week follow-up after the procedure, dose titration upto 120 mg per day will be made if the patient is not hypotensive. |
|
| Placebo | Placebo Comparator | Initial dose will be started with 60mg per day. At 4 week follow-up after the procedure, dose titration upto 120 mg per day will be made if the patient is not hypotensive. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan | Drug | 60-120mg/day (target dose) of Fimasartan will be administered for the study period (till the follow-up angiography) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in percent necrotic core (NC) volume of plaque by VH (Virtual Histology) in the "target segment" (within deferred vessel) | baseline and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline and 1 year | |
| Percent change in minimal lumen area (MLA) in target segment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Jung Park, MD, PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hospital | Gwangju | 501-757 | South Korea | |||
| Asan Medical Center |
This is not a publicly funded trial.
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
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| Placebo | Drug | 60-120mg/day (target dose) of Placebo will be administered for the study period (till the follow-up angiography) |
|
| 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 | baseline and 1 year |
| Change of VH-IVUS (Intra Vascular UltraSound) detected plaque type from baseline | at 1 year |
| Change of percentage (%) of OCT (Optical Coherence Tomography)-defined TCFA (Thin Cap Fibrotic Atheroma) within the target segment from baseline | at 1 year |
| Change of composition of OCT-defined fibrous, fibro-calcific, and lipid-rich plaque within the target segment | baseline and 1 year |
| Change of OCT-defined fibrous cap thickness, the presence of plaque disruption, calcification or intraluminal thrombus within the target segment | baseline and 1 year |
| Change of FFR in target segment from baseline | at 1 year |
| systolic and diastolic blood pressure | at 1 year follow-up |
| Change in high sensitive CRP (C-Reactive Protein)from baseline | at 1 year |
| Seoul |
| 138-736 |
| South Korea |
| Ulsan University Hospital | Ulsan | 682-714 | South Korea |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |