WARRIOR Ancillary Study for CCTA Analysis

Coronary Artery Disease Clinical Trial

Official title:

Effect of Intensive Medical Treatment on Quantified Coronary Artery Plaque Components With Serial Coronary CTA in Women With NonObstructive CAD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05035056
• Other study ID #: STUDY00000896
• Secondary ID: 1R01HL151266
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: July 2023
• Source: Cedars-Sinai Medical Center
• Contact: Damini Dey, PhD
• Phone: 310 423-1517
• Email: damini.dey[@]cshs.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study, quantitative characterization of plaque using coronary computed tomographic angiography (CTA) will be used to determine if women who were treated with intensive medical therapy have a greater reduction in the amount and type of cholesterol plaque compared to women receiving usual care and if this results in beneficial changes in clinical symptoms. The study will provide an understanding of how intensive medical therapy works in providing clinical benefit in women with nonobstructive plaque.

Description:

This is an ancillary substudy of the WARRIOR Trial (NCT03417388), a multi-site, PROBE design, that will evaluate an intensive statin/ACE-I (or ARB)/aspirin treatment strategy (IMT) vs. primary prevention risk factor therapy treatment strategy (UC) in 4,422 symptomatic (chronic angina or equivalent) women with non-obstructive CAD (<50% diameter narrowing).

In this ancillary substudy, 204 patients will be recruited from the WARRIOR trial with 102 patients from each of the treatment groups (IMT vs UC). From this cohort, 102 patients per treatment group, most compliant with WARRIOR protocol will undergo a CTA from any time from 2 years post-baseline up to the end of the main WARRIOR study; with changes in plaque and PCAT characteristics quantified.

The main aims are as follows:

1. To compare changes in coronary plaque characteristics and their hemodynamic significance using CTA in WARRIOR women treated with IMT vs UC;

2. To compare changes in plaque inflammation-related characteristics in PCAT in WARRIOR women treated with IMT with statin in combination with angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) medications vs UC;

3. To relate plaque burden and plaque composition, CT flow reserve, and PCAT density changes to angina score (Seattle Angina Questionnaire [SAQ]) changes in IMT and UC-randomized WARRIOR women.

Data to be analyzed include CT angiography scans at baseline and Year 3 follow-up and corresponding study data and laboratory tests (e.g. hsCRP); plus, selected data from the main WARRIOR study that are relevant to the present ancillary study.

UPDATE; In this ancillary study, 204 patients will be recruited from the WARRIOR Trial with 102 patients from each of the treatment groups (IMT vs UC). From this cohort, 102 patients per treatment group, most compliant with WARRIOR protocol will undergo a CTA as early as 2 years after their WARRIOR baseline scan up to study completion; with changes in plaque and CAT characteristics quantified.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• In addition to the inclusion criteria of the WARRIOR trial, only women who meet the following criteria will undergo final CTA at the same sites where they are screened and enrolled.

• Initial CTA with excellent or good image quality-defined as images where we are able to clearly identify the atherosclerotic plaque. Based on our preliminary assessment, we expect 90% of studies to be included.

• Measurable plaque with NCP volume = 200mm3; women without significant plaque will not receive additional radiation, and we can detect measurable changes in plaque burden and plaque composition.

Exclusion Criteria:

• In addition to exclusion criteria of the parent WARRIOR trial, key exclusion criteria are:

• Non-adherent with IMT. The parent trial is already powered for non-adherence. In our ancillary trial we have built in an exclusion, from final analysis, of an additional 30% who may be nonadherent with IMT or UC.

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia
• Non-Obstructive Coronary Atherosclerosis

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in atherosclerotic plaque burden and noncalcified plaque composition	Change in atherosclerotic plaque burden (%) and noncalcified plaque composition (%) using Autoplaque plaque analysis software	3 years
Primary	Change in coronary plaque inflammation (measured as CT attenuation of Pericoronary adipose tissue)	Change in pericoronary artery adipose tissue (PCAT) density (CT attenuation of PCAT, in Hounsfield Units) by Autoplaque plaque analysis software	3 years
Primary	Change in angina score assessed by the Seattle Angina Questionnaire (SAQ)	Change in angina score quantified by the Seattle Angina Questionnaire (SAQ)	3 years