Coronary Artery DiseaseACROSSNCT03414840
Assessment of Change in Atherosclerotic Plaque by Serial CCTA
An observational study of Coronary Artery Disease and Hydroxymethylglutaryl-CoA Reductase Inhibitors, run by Yonsei University at 1 site in South Korea.
Trial summary
Assessment of Change in AtheROSclerotic Plaque by Serial CCTA (ACROSS) is designed as a prospective observational study which aim is to demonstrate the effect of statins on coronary atherosclerosis, assessed by quantitative analysis of CCTA. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Coronary Arteriosclerosis
- What is being tested?
- Atorvastatin
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2018to 31 Oct 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent clinically indicated CCTA and confirmed to have coronary atherosclerosis will be enrolled.
Who may be able to join
- Patients who underwent clinically indicated CCTA (index CCTA)
- Mild to moderate stenosis (25-69%) on CCTA
- ≥1 clinical risk factors (Smoking, HTN, HDL<40, Premature FHx, M ≥45, F ≥55) for CAD
Who cannot join
- Acute coronary syndrome (unstable angina or MI)
- Positive (not equivocal) stress test
- Contraindications to statin
Trial locations and contacts
1 site in 1 country.
Sang-Eun Lee, MD, PhD contact
South Korea1 site, 1 recruiting
- Recruiting
Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 120-752
Hyuk-Jae Chang, MD, PhD
About this study
Assessment of Change in AtheROSclerotic Plaque by Serial CCTA (ACROSS) is designed as a prospective observational study which aim is to demonstrate the effect of statins on coronary atherosclerosis, assessed by quantitative analysis of CCTA.
- Conditions
- Coronary Artery Disease, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Coronary Arteriosclerosis
- Being tested
- Atorvastatin
- Keywords
- coronary artery disease, coronary computed tomography angiography, statins, coronary atherosclerosis
- 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.
AtorvastatinDrug
Patients diagnosed with coronary artery disease by CCTA be enrolled. Among enrolled patients, patients who is indicated to statin treatment according to the current ACC/AHA guideline will be treated with atorvastatin.
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in percent change of total atheroma volume assessed by CCTA between statin-taking and statin-naïve group
Patients indicated with statin therapy according to current guideline will receive atorvastatin.
Measured: 24 months
Secondary outcomes (1)
Change of total atheroma volume at 24 months compared with baseline total atheroma volume
total atheroma volume assessed by CCTA
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start1 Apr 2018
- Primary completion28 Feb 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
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 Yonsei UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical Corp.
- Responsible party
- Principal investigator, Hyuk-Jae Chang, Yonsei University
- Investigators
- Hyuk-Jae Chang, MD, PhD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414840
- Sponsor's protocol ID
- 2017-2669-001
- Acronym
- ACROSS
- Status last verified
- Jun 2018
- First submitted
- 23 Jan 2018
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Change in Atherosclerotic Plaque by Serial CCTA
- ClinicalTrials.gov ID
- NCT03414840
- Acronym / sponsor ID
- ACROSS / 2017-2669-001
- Conditions
- Coronary Artery Disease, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Coronary Arteriosclerosis
- Keywords
- coronary artery disease, coronary computed tomography angiography, statins, coronary atherosclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical Corp.
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 30 Jan 2018 (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.
Assessment of Change in AtheROSclerotic Plaque by Serial CCTA (ACROSS) is designed as a prospective observational study which aim is to demonstrate the effect of statins on coronary atherosclerosis, assessed by quantitative analysis of CCTA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent clinically indicated CCTA and confirmed to have coronary atherosclerosis will be enrolled.
Key inclusion criteria (3 listed)
- Patients who underwent clinically indicated CCTA (index CCTA)
- Mild to moderate stenosis (25-69%) on CCTA
- ≥1 clinical risk factors (Smoking, HTN, HDL<40, Premature FHx, M ≥45, F ≥55) for CAD
Key exclusion criteria (3 listed)
- Acute coronary syndrome (unstable angina or MI)
- Positive (not equivocal) stress test
- Contraindications to statin
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 |
|---|---|---|
| AtorvastatinPatients diagnosed with coronary artery disease by CCTA be enrolled. Among enrolled patients, patients who is indicated to statin treatment according to the current ACC/AHA guideline will be treated with atorvastatin. | Drug | – |
Primary outcome
Difference in percent change of total atheroma volume assessed by CCTA between statin-taking and statin-naïve group
Time frame: 24 months
Patients indicated with statin therapy according to current guideline will receive atorvastatin.
1 secondary outcome
Change of total atheroma volume at 24 months compared with baseline total atheroma volume
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- 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.
Sang-Eun Lee, MD, PhD contact
Hyuk-Jae Chang, MD, PhD principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Hydroxymethylglutaryl-CoA Reductase Inhibitors, run by Yonsei University 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 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 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyuk-Jae Chang, MD, PhD (+82-2-2228-8454, hjchang@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in percent change of total atheroma volume assessed by CCTA between statin-taking and statin-naïve group (time frame: 24 months). 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 29 Jun 2018.