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Coronary Artery DiseasePhase 4NCT01384747

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

A Phase 4 study testing Fimasartan in people with Coronary Artery Disease, run by Seung-Jung Park at 3 sites in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 19 to 84 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Fimasartan
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
186 participants
Where
3 sitesSouth Korea
Study dates
Jul 2011to Mar 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 18 < 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)

Who cannot join

  • 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
Show all 25Show fewer
  • 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
  • Patients with history of previous enrollment into a clinical trials within 3 months
  • Allergic or contraindicated to Angiotensin II antagonists
  • History of any arterial bypass or angioplastic intervention involving the target vessel
  • Luminal narrowing in the left main > 50% by visual inspection of angiogram
  • Visually-estimated angiographic reference segment diameter of <2.75mm or >4.0 mm
  • Presence of thrombus or complex plaque morphology in the target vessel that suggests a high likelihood of distal embolism
  • Severe tortuosity of the target vessel or any other anatomical reasons that the investigator deems
  • Inappropriate for IVUS procedures. Vessel with thrombus (on GS-IVUS), moderate or severe calcification, angulation
  • Culprit vessel in AMI
  • RWMA (Regional Wall Motion Abnormality) or scar tissue in the territory subtended by the studied lesion

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • Chonnam National University Hospital

    Gwangju, 501-757

  • Asan Medical Center

    Seoul, 138-736

  • Ulsan University Hospital

    Ulsan, 682-714

Other trials in South Korea

About this study

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

  • 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.
Read the 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.

Being tested
Fimasartan, Placebo
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FimasartanDrug

    Also called Kanarb Tab.

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

  • PlaceboDrug

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

Study groups in NCT01384747
Study groupRoleWhat they receive
FimasartanExperimentalInitial 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.
Receives: Drug: Fimasartan
PlaceboPlacebo comparatorInitial 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: baseline and 1 year

Secondary outcomes (10)

  1. 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

    Measured: baseline and 1 year

  2. Percent change in minimal lumen area (MLA) in target segment

    Measured: baseline and 1 year

  3. 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

    Measured: baseline and 1 year

  4. Change of VH-IVUS (Intra Vascular UltraSound) detected plaque type from baseline

    Measured: at 1 year

  5. Change of percentage (%) of OCT (Optical Coherence Tomography)-defined TCFA (Thin Cap Fibrotic Atheroma) within the target segment from baseline

    Measured: at 1 year

  6. Change of composition of OCT-defined fibrous, fibro-calcific, and lipid-rich plaque within the target segment

    Measured: baseline and 1 year

  7. Change of OCT-defined fibrous cap thickness, the presence of plaque disruption, calcification or intraluminal thrombus within the target segment

    Measured: baseline and 1 year

  8. Change of FFR in target segment from baseline

    Measured: at 1 year

  9. systolic and diastolic blood pressure

    Measured: at 1 year follow-up

  10. Change in high sensitive CRP (C-Reactive Protein)from baseline

    Measured: at 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionMar 2018
  4. Study completionMar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01384747
Sponsor's protocol ID
CVRF2011-03
Status last verified
Jun 2018
First submitted
24 Jun 2011
Last updated
20 Jun 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: This is not a publicly funded trial.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fimasartan in people with Coronary Artery Disease, run by Seung-Jung Park at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01384747.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.

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