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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
CardioVascular Research Foundation, Korea
Boryung Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01384747
First received: June 24, 2011
Last updated: February 23, 2017
Last verified: February 2017
  Purpose
  • 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.

Condition Intervention Phase
Coronary Artery Disease Drug: Fimasartan Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Study of Effect of Fimasartan for Modification of Atheroma Vulnerability in DEFERred Coronary Disease

Resource links provided by NLM:


Further study details as provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 [ 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 ]

Enrollment: 186
Study Start Date: July 2011
Estimated Study Completion Date: May 31, 2019
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fimasartan
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
60-120mg/day (target dose) of Fimasartan will be administered for the study period (till the follow-up angiography)
Other Name: Kanarb Tab.
Placebo Comparator: Placebo
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
60-120mg/day (target dose) of Placebo will be administered for the study period (till the follow-up angiography)

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.
  Eligibility

Ages Eligible for Study:   19 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. 18 < Age < 85
  3. Patient who has received informed consent
  4. 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)

Exclusion Criteria:

  1. Planned cardiac surgery (e.g., CABG, valve repair or replacement, or aneurysmectomy) or planned major non-cardiac surgery within the study period
  2. Planned performance of PCI or CABG in the target vessel or its branches containing the index
  3. Evidence of congestive heart failure, or left ventricular ejection fraction < 40%
  4. Stroke or resuscitated sudden death in the past 6 months
  5. Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible)
  6. 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
  7. 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
  8. Significant renal disease manifested by serum creatinine > 1.5 mg/dL
  9. Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal)
  10. Active hepatitis B or C or carrier
  11. Hypotension (systolic blood pressure <90 mmHg)
  12. Patients already taking ACE inhibitors or ARBs
  13. Patients with STEMI requiring primary PCI
  14. Patients pregnant or breast-feeding or child-bearing potential
  15. Patients who are lack of intention for effective contraception
  16. Patients with history of previous enrollment into a clinical trials within 3 months
  17. Allergic or contraindicated to Angiotensin II antagonists
  18. History of any arterial bypass or angioplastic intervention involving the target vessel
  19. Luminal narrowing in the left main > 50% by visual inspection of angiogram
  20. Visually-estimated angiographic reference segment diameter of <2.75mm or >4.0 mm
  21. Presence of thrombus or complex plaque morphology in the target vessel that suggests a high likelihood of distal embolism
  22. Severe tortuosity of the target vessel or any other anatomical reasons that the investigator deems
  23. Inappropriate for IVUS procedures. Vessel with thrombus (on GS-IVUS), moderate or severe calcification, angulation
  24. Culprit vessel in AMI
  25. RWMA (Regional Wall Motion Abnormality) or scar tissue in the territory subtended by the studied lesion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384747

Locations
Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of, 501-757
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Ulsan University Hospital
Ulsan, Korea, Republic of, 682-714
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Boryung Pharmaceutical Co., Ltd
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center
  More Information

Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01384747     History of Changes
Other Study ID Numbers: CVRF2011-03
Study First Received: June 24, 2011
Last Updated: February 23, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: This is not a publicly funded trial.

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Plaque, Atherosclerotic
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 22, 2017