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

NCT01384747 | Terminated Phase 4 DMC

• 1 other identifier: CVRF2011-03
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Change in percent necrotic core (NC) volume of plaque by VH (Virtual Histology) in the "target segment" (within deferred vessel)

  baseline and 1 year

Secondary Outcomes (10)

• 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

  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

Study Arms (2)

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.

Drug: Fimasartan

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.

Drug: Placebo

Interventions

Fimasartan DRUG

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

Also known as: Kanarb Tab.

Fimasartan

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 19 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypertensive patients (systolic blood pressure \>140mmHg or diastolic blood pressure \>90mmHg) or medically treated hypertension with normal blood pressure who undergo coronary angiography with clinical indications
• \< Age \< 85
• Patient who has received informed consent
• 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 (FFR ≥ 0.8 or negative perfusion defect on thallium scan or negative treadmill test)

You may not qualify if:

• Planned cardiac surgery (e.g., CABG, valve repair or replacement, or aneurysmectomy) or planned major non-cardiac surgery within the study period
• Planned performance of PCI or CABG in the target vessel or its branches containing the index
• Evidence of congestive heart failure, or left ventricular ejection fraction \< 40%
• Stroke or resuscitated sudden death in the past 6 months
• Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible)
• A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer
• Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study
• Significant renal disease manifested by serum creatinine \> 1.5 mg/dL
• Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 3 times upper limit of normal)
• Active hepatitis B or C or carrier
• Hypotension (systolic blood pressure \<90 mmHg)
• Patients already taking ACE inhibitors or ARBs
• Patients with STEMI requiring primary PCI
• Patients pregnant or breast-feeding or child-bearing potential
• Patients who are lack of intention for effective contraception

Sponsors & Collaborators

• Seung-Jung Park: lead
• CardioVascular Research Foundation, Korea: collaborator
• Boryung Pharmaceutical Co., Ltd: collaborator

Study Sites (3)

Chonnam National University Hospital

Gwangju, 501-757, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Ulsan University Hospital

Ulsan, 682-714, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

fimasartan

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Seung-Jung Park, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: June 29, 2011
• Study Start: July 1, 2011
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: June 20, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)