Coronary Artery DiseasePhase 4ARTCAPNCT06280976
Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)
A Phase 4 study testing Statin, Aspirin tablet and Nexlizet in people with Coronary Artery Disease and Atherosclerosis, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the role of coronary CT angiogram (CCTA) as a superior guide for the assessment of coronary artery plaque and guiding treatment decisions. The investigators also assess the impact of preventive cardiovascular drugs on the plaque to improve patient outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis, Heart Attack
- What is being tested?
- Statin, Aspirin tablet and Nexlizet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 1 Jan 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-obstructive atherosclerotic coronary artery plaque (stenosis of 0-39% or stenosis of 40-69% with FFR-CT >0.8) in a major epicardial vessel > 2 mm in diameter.
Who cannot join
- coronary/PAD/carotid revascularization or ischemic stroke or TIA within 6 months prior to enrollment
- Valvular heart disease of moderate or worse severity or requiring interventional procedures or surgery
- LVEF <35% in the past 12 months
- Pulmonary hypertension with PASP>50 mm Hg in the past 12 months
- Myocarditis or pericarditis in the past 12 months
- Known Cardiomyopathy (hypertrophic, infiltrative, restrictive, dilated, etc.)
Show all 20Show fewer
- Heart failure NYHA class 3 or 4
- Hospitalization for heart failure in the preceding 6 months
- Life expectancy of <1 year
- An organ-transplant recipient or if felt to require listing for solid organ transplantation during study status
- Inability to give informed consent
- Active malignancy (except basal cell skin cancer)
- Cirrhosis
- ESRD
- Pregnancy or planning to conceive during the study period
- Known intolerance or perceived contraindication to any of the study drugs during the study period including statins or aspirin if indicated
- eGFR<30 ml/min/m2
- Inability to receive iodinated contrast for CCTA
- Chronic immunosuppression therapy
- Uncontrolled psychiatric illness
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville School of Medicine, Division of Cardiovascular Diseases
Louisville, Kentucky, 40202
About this study
The purpose of this study is to evaluate the role of coronary CT angiogram (CCTA) as a superior guide for the assessment of coronary artery plaque and guiding treatment decisions. The investigators also assess the impact of preventive cardiovascular drugs on the plaque to improve patient outcomes. Participants aged 18-80 years, at intermediate or high-risk for coronary artery disease, with non-obstructive plaque on initial CCTA, will be enrolled in this study. They will be randomized into Standard of Care (SOC) vs. Aggressive Therapy (AT) groups. Both groups will undergo dietary and lifestyle interventions. Follow-up will consist of blood tests and clinic visits at baseline, 9 months, and 18 months. The second CCTA will be performed at 18 months to assess the change in plaque burden, characteristics, ischemia and pericoronary/epicardial fat.
Read the detailed description
ART-CAP (Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque ) is a prospective randomized open-label trial with blinded end-point. This research project aims to study the role of coronary computed tomographic angiography (CCTA) as a superior guide for the direct assessment and monitoring of the impact of preventive cardiovascular drugs on coronary artery plaque for better clinical decision-making and improving patient outcomes. Participants aged 18-80 years, at intermediate or high-risk (10-year ASCVD risk of 5-20% or >20%; calculated based on age, gender, race, history of smoking, diabetes mellitus, hypertension, hyperlipidemia, and family history of premature CAD, with/without symptoms suggestive of coronary disease) who has non-obstructive plaque on CCTA (stenosis of 0-39% or 40-69% with FFR-CT >0.8), will be enrolled. Participants with a history of heart attack, coronary stents or bypass surgery, recent stroke, severe valvular heart disease, pulmonary hypertension, NYHA class 3 or 4 heart failure, recent heart failure hospitalization, active cancer, life expectancy of <1 year, end-stage kidney or liver disease, pregnancy or uncontrolled psychiatric illness, will be excluded.
Participants will be randomly assigned to two groups - Standard of Care (SOC, 100 pts) vs. Aggressive Therapy (AT, 100 pts). Both groups will receive dietary and lifestyle interventions. SOC will be treated with statin and/or aspirin as per the ACC guidelines. AT group will be treated with statin, aspirin, nexlizet, leqvio, vascepa, jardiance, and colchicine. Follow-up will consist of blood tests and clinic visits at baseline, 9 months, and 18 months. At baseline, participants will undergo Polygenic Risk Score (PRS) and next-generation sequencing (NGS) for a South Asian gene panel. Biomarker evaluations at baseline, 9 months, and 18 months include lipid profiles, inflammatory markers, cardiac biomarkers, and buffy coat analysis for CHIP, along with standard blood tests including CBC and CMP. Additionally, echocardiographic evaluation will be performed at baseline and 18 months.
After 18 months of medical treatment, a repeat CCTA will be performed to evaluate primary endpoints of the percentage change in plaque burden (total, non-calcified and calcified), plaque characteristics including high-risk features, ischemia value for the most severe lesion, and pericoronary/epicardial fat attenuation. Patient will be followed for additional 5 years for MACCE (major adverse cardiovascular and cerebrovascular events).
- Conditions
- Coronary Artery Disease, Atherosclerosis, Heart Attack
- Being tested
- Statin, Aspirin tablet, Nexlizet, LEQVIO, Vascepa
- Keywords
- Coronary artery plaque, Coronary CT angiogram
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatinDrug
Also called atorvastatin
high intensity statin (eg atorvastatin 80 mg daily)
Aspirin tabletDrug
Also called aspirin 81 mg
aspirin 81 mg po qd
NexlizetDrug
Also called bempedoic acid-ezetimibe
bempedoic acid-ezetimibe 180-10 mg po qd
LEQVIODrug
Also called inclisiran
inclisiran SQ as per product insert
VascepaDrug
Also called icosapent ethyl
icosapent ethyl 2g PO BID
JardianceDrug
Also called empagliflozin
empagliflozin 10 mg PO QD
ColchicineDrug
Colchicine 0.5 MG po qd
| Study group | Role | What they receive |
|---|---|---|
| SOC: Statin ± Aspirin (per ACC guidelines) | Active comparator | The SOC group: participant receive routine care as per cardiologist. Study doctor will prescribe medications that they choose themselves. Receives: Drug: Statin; Drug: Aspirin tablet |
| AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine | Experimental | An AT group: FDA-approved drugs will be used to reduce cholesterol and cardiovascular risk. Receives: Drug: Statin; Drug: Aspirin tablet; Drug: Nexlizet; Drug: LEQVIO; Drug: Vascepa; Drug: Jardiance; Drug: Colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque quantification
Quantification of plaque including total plaque, calcified plaque, non-calcified plaque, and partially calcified plaque. Units: mm3
Measured: Baseline, 18 months
Characterization of plaque to evaluate for high-risk features - positive remodeling
Characterization of plaque to evaluate for high-risk features - positive remodeling Units: no units (yes or no)
Measured: Baseline, 18 months
Quantification of stenosis
Quantification of stenosis by using CT-FFR. Unit: percentage
Measured: Baseline, 18 months
Quantification of pericoronary fat attenuation.
Quantification of pericoronary and epicardial fat attenuation. Unit: Fat attenuation index [ranging from -190 to -30 Hounsfield units (HU)]
Measured: Baseline, 18 months
Characterization of plaque to evaluate for high-risk features - low CT attenuation
Characterization of plaque to evaluate for high-risk features - low CT attenuation Units: no units (yes or no)
Measured: Baseline, 18 months
Characterization of plaque to evaluate for high-risk features - napkin-ring sign
Characterization of plaque to evaluate for high-risk features - napkin-ring sign Units: no units (yes or no)
Measured: Baseline, 18 months
Quantification of epicardial fat attenuation.
Quantification of epicardial fat attenuation. Unit: Fat attenuation index [ranging from -190 to -30 Hounsfield units (HU)]
Measured: Baseline, 18 months
Secondary outcomes (13)
Major adverse cardiac and cardiovascular events (MACCE)
Number of participants with adjusted events including non-fatal myocardial infarction, stroke, transient ischemic attack, urgent revascularization, cardiovascular hospitalization, hospitalization for heart failure, and cardiovascular death.
Unit: number of events
Measured: 5 years
Polygenic risk score (PRS)
Polygenic risk score (PRS) to estimate the participant's genetic susceptibility for coronary artery disease, assessed via blood draw.
Unit: No units (weighted score ranging from 0-100)
Measured: Baseline
Next generation sequencing (NGS)
Next generation sequencing (NGS) to identify mutations associated with coronary artery disease, assessed via blood draw.
Unit: Mutation in disease-genes
Measured: Baseline
Change in Lipoprotein (a)
Change in Lipoprotein (a) level as assessed via blood draw. Unit: nmol/L
Measured: Baseline, 9 and 18 months
Change in myeloperoxidase (MPO) activity
Change in myeloperoxidase (MPO) activity, as assessed via blood draw. Unit: μU/mg
Measured: Baseline, 9 and 18 months
Change in trimethylamine-N-oxide (TMAO) levels
Change in trimethylamine-N-oxide (TMAO) levels, assessed via blood draw. Unit: µM
Measured: Baseline, 9 and 18 months
Change in lipoprotein-associated phospholipase A2 (Lp-PLA2) levels
Change in lipoprotein-associated phospholipase A2 (Lp-PLA2) levels, as assessed by blood draw.
Unit: ng/mL
Measured: Baseline, 9 and 18 months
Change in interleukin-6 (IL-6) levels
Change in interleukin-6 (IL-6) levels, as assessed by blood draw. Unit: pg/mL
Measured: Baseline, 9 and 18 months
Change in high sensitivity C-creative protein (HS-CRP) levels
Change in high sensitivity C-creative protein (HS-CRP) levels as assessed by blood draw.
Units: mg/mL
Measured: Baseline, 9 and 18 months
Buffy coat for chromatin immunoprecipitation (ChIP)
Buffy coat for chromatin immunoprecipitation (ChIP) as assessed by blood draw. Unit: Genomic locations of binding of various proteins involved in coronary plaque formation
Measured: Baseline, 9 and 18 months
Change in high sensitivity Troponin (HS-Tn)
Change in high sensitivity Troponin (HS-Tn), as assessed by blood draw. Unit: ng/mL
Measured: Baseline, 9 and 18 months
Change in natriuretic peptide (BNP, NT-pro BNP
Change in natriuretic peptide (BNP, NT-pro BNP), as assessed by blood draw. Unit: pg/mL
Measured: Baseline, 9 and 18 months
Change in levels of open reading frame 1 protein (ORF1p)
Change in levels of open reading frame 1 protein (ORF1p), as assessed by blood draw using enzyme-linked immunosorbent assay (ELISA) or western blotting.
Unit: μg/mL
Measured: Baseline, 9 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Mar 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Why it stopped: study withdrawn, no participants enrolled, changes in the study design planned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- PROBE design: Prospective Randomized Open Label Blinded End-point
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dinesh Kalra, MD, University of Louisville
- Investigators
- Dinesh Kalra, MD, Principal investigator, University of Louisville School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280976
- Sponsor's protocol ID
- 23.0001
- Acronym
- ARTCAP
- Status last verified
- Apr 2024
- First submitted
- 5 Feb 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)
- ClinicalTrials.gov ID
- NCT06280976
- Acronym / sponsor ID
- ARTCAP / 23.0001
- Conditions
- Coronary Artery Disease, Atherosclerosis, Heart Attack
- Keywords
- Coronary artery plaque, Coronary CT angiogram
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study withdrawn, no participants enrolled, changes in the study design planned
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 28 Feb 2024 (actual)
- 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 role of coronary CT angiogram (CCTA) as a superior guide for the assessment of coronary artery plaque and guiding treatment decisions. The investigators also assess the impact of preventive cardiovascular drugs on the plaque to improve patient outcomes. Participants aged 18-80 years, at intermediate or high-risk for coronary artery disease, with non-obstructive plaque on initial CCTA, will be enrolled in this study. They will be randomized into Standard of Care (SOC) vs. Aggressive Therapy (AT) groups. Both groups will undergo dietary and lifestyle interventions. Follow-up will consist of blood tests and clinic visits at baseline, 9 months, and 18 months. The second CCTA will be performed at 18 months to assess the change in plaque burden, characteristics, ischemia and pericoronary/epicardial fat.
Detailed description
ART-CAP (Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque ) is a prospective randomized open-label trial with blinded end-point. This research project aims to study the role of coronary computed tomographic angiography (CCTA) as a superior guide for the direct assessment and monitoring of the impact of preventive cardiovascular drugs on coronary artery plaque for better clinical decision-making and improving patient outcomes. Participants aged 18-80 years, at intermediate or high-risk (10-year ASCVD risk of 5-20% or >20%; calculated based on age, gender, race, history of smoking, diabetes mellitus, hypertension, hyperlipidemia, and family history of premature CAD, with/without symptoms suggestive of coronary disease) who has non-obstructive plaque on CCTA (stenosis of 0-39% or 40-69% with FFR-CT >0.8), will be enrolled. Participants with a history of heart attack, coronary stents or bypass surgery, recent stroke, severe valvular heart disease, pulmonary hypertension, NYHA class 3 or 4 heart failure, recent heart failure hospitalization, active cancer, life expectancy of <1 year, end-stage kidney or liver disease, pregnancy or uncontrolled psychiatric illness, will be excluded.
Participants will be randomly assigned to two groups - Standard of Care (SOC, 100 pts) vs. Aggressive Therapy (AT, 100 pts). Both groups will receive dietary and lifestyle interventions. SOC will be treated with statin and/or aspirin as per the ACC guidelines. AT group will be treated with statin, aspirin, nexlizet, leqvio, vascepa, jardiance, and colchicine. Follow-up will consist of blood tests and clinic visits at baseline, 9 months, and 18 months. At baseline, participants will undergo Polygenic Risk Score (PRS) and next-generation sequencing (NGS) for a South Asian gene panel. Biomarker evaluations at baseline, 9 months, and 18 months include lipid profiles, inflammatory markers, cardiac biomarkers, and buffy coat analysis for CHIP, along with standard blood tests including CBC and CMP. Additionally, echocardiographic evaluation will be performed at baseline and 18 months.
After 18 months of medical treatment, a repeat CCTA will be performed to evaluate primary endpoints of the percentage change in plaque burden (total, non-calcified and calcified), plaque characteristics including high-risk features, ischemia value for the most severe lesion, and pericoronary/epicardial fat attenuation. Patient will be followed for additional 5 years for MACCE (major adverse cardiovascular and cerebrovascular events).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- PROBE design: Prospective Randomized Open Label Blinded End-point
| Arm | Type | Receives |
|---|---|---|
| SOC: Statin ± Aspirin (per ACC guidelines) | Active comparator | Drug: Statin, Drug: Aspirin tabletThe SOC group: participant receive routine care as per cardiologist. Study doctor will prescribe medications that they choose themselves. |
| AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine | Experimental | Drug: Statin, Drug: Aspirin tablet, Drug: Nexlizet, Drug: LEQVIO, Drug: Vascepa, Drug: Jardiance, Drug: ColchicineAn AT group: FDA-approved drugs will be used to reduce cholesterol and cardiovascular risk. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non-obstructive atherosclerotic coronary artery plaque (stenosis of 0-39% or stenosis of 40-69% with FFR-CT >0.8) in a major epicardial vessel > 2 mm in diameter.
Key exclusion criteria (20 listed)
- coronary/PAD/carotid revascularization or ischemic stroke or TIA within 6 months prior to enrollment
- Valvular heart disease of moderate or worse severity or requiring interventional procedures or surgery
- LVEF <35% in the past 12 months
- Pulmonary hypertension with PASP>50 mm Hg in the past 12 months
- Myocarditis or pericarditis in the past 12 months
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 |
|---|---|---|
| StatinAlso: atorvastatinhigh intensity statin (eg atorvastatin 80 mg daily) | Drug | AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine, SOC: Statin ± Aspirin (per ACC guidelines) |
| Aspirin tabletAlso: aspirin 81 mgaspirin 81 mg po qd | Drug | AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine, SOC: Statin ± Aspirin (per ACC guidelines) |
| NexlizetAlso: bempedoic acid-ezetimibebempedoic acid-ezetimibe 180-10 mg po qd | Drug | AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine |
| LEQVIOAlso: inclisiraninclisiran SQ as per product insert | Drug | AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine |
| VascepaAlso: icosapent ethylicosapent ethyl 2g PO BID | Drug | AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine |
| JardianceAlso: empagliflozinempagliflozin 10 mg PO QD | Drug | AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine |
| ColchicineColchicine 0.5 MG po qd | Drug | AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine |
Primary outcome
Plaque quantification
Time frame: Baseline, 18 months
Quantification of plaque including total plaque, calcified plaque, non-calcified plaque, and partially calcified plaque. Units: mm3
Characterization of plaque to evaluate for high-risk features - positive remodeling
Time frame: Baseline, 18 months
Characterization of plaque to evaluate for high-risk features - positive remodeling Units: no units (yes or no)
Quantification of stenosis
Time frame: Baseline, 18 months
Quantification of stenosis by using CT-FFR. Unit: percentage
Quantification of pericoronary fat attenuation.
Time frame: Baseline, 18 months
Quantification of pericoronary and epicardial fat attenuation. Unit: Fat attenuation index [ranging from -190 to -30 Hounsfield units (HU)]
Characterization of plaque to evaluate for high-risk features - low CT attenuation
Time frame: Baseline, 18 months
Characterization of plaque to evaluate for high-risk features - low CT attenuation Units: no units (yes or no)
Characterization of plaque to evaluate for high-risk features - napkin-ring sign
Time frame: Baseline, 18 months
Characterization of plaque to evaluate for high-risk features - napkin-ring sign Units: no units (yes or no)
Quantification of epicardial fat attenuation.
Time frame: Baseline, 18 months
Quantification of epicardial fat attenuation. Unit: Fat attenuation index [ranging from -190 to -30 Hounsfield units (HU)]
13 secondary outcomes
Major adverse cardiac and cardiovascular events (MACCE)
Time frame: 5 years
Polygenic risk score (PRS)
Time frame: Baseline
Next generation sequencing (NGS)
Time frame: Baseline
Change in Lipoprotein (a)
Time frame: Baseline, 9 and 18 months
Change in myeloperoxidase (MPO) activity
Time frame: Baseline, 9 and 18 months
Change in trimethylamine-N-oxide (TMAO) levels
Time frame: Baseline, 9 and 18 months
Change in lipoprotein-associated phospholipase A2 (Lp-PLA2) levels
Time frame: Baseline, 9 and 18 months
Change in interleukin-6 (IL-6) levels
Time frame: Baseline, 9 and 18 months
Change in high sensitivity C-creative protein (HS-CRP) levels
Time frame: Baseline, 9 and 18 months
Buffy coat for chromatin immunoprecipitation (ChIP)
Time frame: Baseline, 9 and 18 months
Change in high sensitivity Troponin (HS-Tn)
Time frame: Baseline, 9 and 18 months
Change in natriuretic peptide (BNP, NT-pro BNP
Time frame: Baseline, 9 and 18 months
Change in levels of open reading frame 1 protein (ORF1p)
Time frame: Baseline, 9 and 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Dinesh Kalra, MD principal investigator
University of Louisville School of Medicine
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 Statin, Aspirin tablet and Nexlizet in people with Coronary Artery Disease and Atherosclerosis, run by University of Louisville at 1 site in United States.
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 1 inclusion and 20 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: withdrawn, as of the sponsor's last update on 17 Mar 2025. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Plaque quantification (time frame: Baseline, 18 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.