Inflammation Plaque, AtheroscleroticPhase 4FACENCT02378064
Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation
A Phase 4 study testing 6-month treatment in people with Inflammation Plaque, Atherosclerotic and Coronary Disease, run by CHEOL WHAN LEE, M.D., Ph.D at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effects of angiotensin receptor 1 blocker versus calcium channel blocker on atherosclerotic plaque inflammation using serial FDG PET/CT imaging of carotid artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation Plaque, Atherosclerotic, Coronary Disease, Renin-Angiotensin System
- What is being tested?
- 6-month treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2015to Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or Women at least 18 years of age inclusive
- Patients with acute coronary syndromes or unstable angina pectoris
- Hypertension or blood pressure more than 140/90mmHg
- FDG PET/CT shows at least 1 hot uptakes at carotid and or ascending aorta
- The patient or guardian agrees to the study protocol and the schedule of clinical and FDG PET/CT follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Who cannot join
- Patients treated with carotid endarterectomy or stent placement
- Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).
- Untreated hyperthyroidism, or hypothyroidism
- 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.
- Evidence of congestive heart failure, or left ventricular ejection fraction < 40%.
- Significant renal disease manifested by serum creatinine > 2.0mg/dL, or creatinine clearance of < 40 ml/min (by Cockcroft-Gault method).
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- Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
- History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s).
- Unwillingness or inability to comply with the procedures described in this protocol.
- Patient's pregnant or breast-feeding or child-bearing potential.
- Type I Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effects of angiotensin receptor 1 blocker versus calcium channel blocker on atherosclerotic plaque inflammation using serial FDG PET/CT imaging of carotid artery.
- Being tested
- 6-month treatment
- Keywords
- Fluorodeoxyglucose F18, Positron-Emission Tomography and Computed Tomography, Plaque, Atherosclerotic, Renin-Angiotensin System
- Medical subject headings
- Coronary Disease, Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-month treatmentDrug
| Study group | Role | What they receive |
|---|---|---|
| Fimasartan and vytorin | Experimental | fimasartan(60mg,QD)+Vytorin(10mg,QD) Receives: Drug: 6-month treatment |
| Fimasartan and rosuvastatin | Experimental | fimasartan(60mg,QD)+rosuvastatin(5mg,QD) Receives: Drug: 6-month treatment |
| amlodipine and vytorin | Active comparator | amlodipine(5mg,QD)+Vytorin(10mg,QD) Receives: Drug: 6-month treatment |
| amlodipine and rosuvastatin | Active comparator | amlodipine(5mg,QD+rosuvastatin(5mg,QD) Receives: Drug: 6-month treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
change (follow-up minus baseline) in standardized FDG uptake value
change (follow-up minus baseline) in standardized FDG uptake value within the regions of interest, known as a target-to-background ratio (blood-normalized standardized uptake value).
Measured: 6month
Secondary outcomes (2)
changes of blood pressure
systolic and diastolic
Measured: 6month
Serial changes of lipid battery
total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol
Measured: 6month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammation Plaque, AtheroscleroticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Factorial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHEOL WHAN LEE, M.D., Ph.D
- Sponsor type
- University, hospital or other
- Collaborators
- Boryung Pharmaceutical Co., Ltd
- Responsible party
- Sponsor-investigator, CHEOL WHAN LEE, M.D., Ph.D, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378064
- Sponsor's protocol ID
- AMCCV2014-10
- Acronym
- FACE
- Status last verified
- Jan 2018
- First submitted
- 26 Feb 2015
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Oh M, Kim H, Shin EW, Sung C, Kim DH, Moon DH, Lee CW. Effects of ezetimibe/simvastatin 10/10 mg versus Rosuvastatin 10 mg on carotid atherosclerotic plaque inflammation. BMC Cardiovasc Disord. 2019 Aug 19;19(1):201. doi: 10.1186/s12872-019-1184-2.
PubMed 31426749
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation
- ClinicalTrials.gov ID
- NCT02378064
- Acronym / sponsor ID
- FACE / AMCCV2014-10
- Keywords
- Fluorodeoxyglucose F18, Positron-Emission Tomography and Computed Tomography, Plaque, Atherosclerotic, Renin-Angiotensin System
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- CHEOL WHAN LEE, M.D., Ph.DUniversity, hospital or other
- Collaborators
- Boryung Pharmaceutical Co., Ltd
- Study start
- May 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effects of angiotensin receptor 1 blocker versus calcium channel blocker on atherosclerotic plaque inflammation using serial FDG PET/CT imaging of carotid artery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fimasartan and vytorin | Experimental | Drug: 6-month treatmentfimasartan(60mg,QD)+Vytorin(10mg,QD) |
| Fimasartan and rosuvastatin | Experimental | Drug: 6-month treatmentfimasartan(60mg,QD)+rosuvastatin(5mg,QD) |
| amlodipine and vytorin | Active comparator | Drug: 6-month treatmentamlodipine(5mg,QD)+Vytorin(10mg,QD) |
| amlodipine and rosuvastatin | Active comparator | Drug: 6-month treatmentamlodipine(5mg,QD+rosuvastatin(5mg,QD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or Women at least 18 years of age inclusive
- Patients with acute coronary syndromes or unstable angina pectoris
- Hypertension or blood pressure more than 140/90mmHg
- FDG PET/CT shows at least 1 hot uptakes at carotid and or ascending aorta
- The patient or guardian agrees to the study protocol and the schedule of clinical and FDG PET/CT follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Key exclusion criteria (11 listed)
- Patients treated with carotid endarterectomy or stent placement
- Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).
- Untreated hyperthyroidism, or hypothyroidism
- 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.
- Evidence of congestive heart failure, or left ventricular ejection fraction < 40%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-month treatment | Drug | Fimasartan and rosuvastatin, Fimasartan and vytorin, amlodipine and rosuvastatin, amlodipine and vytorin |
Primary outcome
change (follow-up minus baseline) in standardized FDG uptake value
Time frame: 6month
change (follow-up minus baseline) in standardized FDG uptake value within the regions of interest, known as a target-to-background ratio (blood-normalized standardized uptake value).
2 secondary outcomes
changes of blood pressure
Time frame: 6month
Serial changes of lipid battery
Time frame: 6month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Derived from this study: PubMed 31426749Oh M, Kim H, Shin EW, Sung C, Kim DH, Moon DH, Lee CW. Effects of ezetimibe/simvastatin 10/10 mg versus Rosuvastatin 10 mg on carotid atherosclerotic plaque inflammation. BMC Cardiovasc Disord. 2019 Aug 19;19(1):201. doi: 10.1186/s12872-019-1184-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 6-month treatment in people with Inflammation Plaque, Atherosclerotic and Coronary Disease, run by CHEOL WHAN LEE, M.D., Ph.D at 1 site 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (follow-up minus baseline) in standardized FDG uptake value (time frame: 6month). 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 NCT02378064, which also lists 1 linked publication.
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 5 Jan 2018.