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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03414840
Other study ID # 2017-2669-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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