Assessment of Change in Atherosclerotic Plaque by Serial CCTA

Coronary Artery Disease Clinical Trial

— ACROSS  

Official title:

Assessment of Change in Atherosclerotic Plaque by Serial CCTA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03414840
• Other study ID #: 2017-2669-001
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: June 2018
• Source: Yonsei University
• Contact: Hyuk-Jae Chang, MD, PhD
• Phone: +82-2-2228-8454
• Email: hjchang[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 31, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Acute coronary syndrome (unstable angina or MI)

• Positive (not equivocal) stress test

• Contraindications to statin

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Coronary Disease
• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Myocardial Ischemia
• Plaque, Atherosclerotic

Intervention

Drug:
• Atorvastatin
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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Cardiovascular Hospital, Yonsei University College of Medicine	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	Chong Kun Dang Pharmaceutical Corp.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Secondary	Change of total atheroma volume at 24 months compared with baseline total atheroma volume	total atheroma volume assessed by CCTA	24 months