NCT01384747

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Seung-Jung Park · Academic / Other
• Sex: All
• Age: 19 Years – 84 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Fimasartan	60-120mg/day (target dose) of Fimasartan will be administered for the study period (till the follow-up angiography)
DRUG	Placebo	60-120mg/day (target dose) of Placebo will be administered for the study period (till the follow-up angiography)

Timeline

• Start date: 2011-07-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2011-06-29
• Last updated: 2018-06-20

Locations

3 sites across 1 country: South Korea