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Effect of Fimasartan for Modification of Atheroma Vulnerability in DEFERred Coronary Disease (FIMA-DEFER)

Coronary Artery Disease Clinical Trial

Official title:
A Randomized, Double-blind Study of Effect of Fimasartan for Modification of Atheroma Vulnerability in DEFERred Coronary Disease

Clinical Trial Summary

- 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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01384747
Study type Interventional
Source CardioVascular Research Foundation, Korea
Contact
Status Terminated
Phase Phase 4
Start date July 2011
Completion date March 2018
View Details
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