Coronary Artery DiseaseNCT05035056
WARRIOR Ancillary Study for CCTA Analysis
An observational study of Coronary Artery Disease and Non-Obstructive Coronary Atherosclerosis, run by Cedars-Sinai Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Coronary Artery Disease, Non-Obstructive Coronary Atherosclerosis, Ischemia
- How many people
- 191 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 31 Jan 2026
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This ancillary sub-study will draw 204 patients from the WARRIOR patient group (4422 women), who have undergone a baseline CTA as part of the WARRIOR trial. From this group, 204 patients most compliant with the medication regimen (intensive medical therapy (IMT) with aspirin, statin, angiotensin-converting enzyme inhibitor, and/or angiotensin receptor blocker) vs. usual care (UC) recommended in their treatment groups will undergo a follow-up coronary CTA.
Who may be able to join
- 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 total plaque volume >0mm3; women without significant plaque will not receive additional radiation, and we can detect measurable changes in plaque burden and plaque composition.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Effect of Intensive Medical Treatment on Quantified Coronary Artery Plaque Components With Serial Coronary CTA in Women With NonObstructive CAD
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.
Read the detailed 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-randomization up to the end of the main WARRIOR study; with changes in plaque and PCAT characteristics quantified.
The main aims are as follows:
- To compare changes in coronary plaque characteristics and their hemodynamic significance using CTA in WARRIOR women treated with IMT vs UC;
- 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;
- 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 randomization to the WARRIOR trial up to study completion; with changes in plaque and CAT characteristics quantified.
- Medical subject headings
- Coronary Artery Disease, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CT Coronary Angiogram with quantitative characterization of plaque | Participants (102) from Intensive Medical Therapy [IMT] and 102 from the Usual Care [UC] group in the WARRIOR trial) will undergo CTA at the Year 3 follow-up visit (can be as early as 2 years from randomization) at their respective enrollment study sites. Quantitative characterization of plaque analysis will be conducted at Cedars-Sinai Medical Center using Autoplaque plaque analysis software. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in atherosclerotic plaque burden and noncalcified plaque composition
Change in atherosclerotic plaque burden (%) and noncalcified plaque composition (%) using Autoplaque plaque analysis software
Measured: 3 years
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
Measured: 3 years
Change in angina score assessed by the Seattle Angina Questionnaire (SAQ)
Change in angina score quantified by the Seattle Angina Questionnaire (SAQ)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Jul 2020
- Primary completion2 May 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Damini Dey, Cedars-Sinai Medical Center
- Investigators
- Damini Dey, PhD, Principal investigator, Cedars-Sinai Medical CenterBalaji Tamarappoo, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035056
- Sponsor's protocol ID
- STUDY00000896
- Other IDs
- 1R01HL151266
- Status last verified
- Mar 2026
- First submitted
- 20 Aug 2021
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tamarappoo B, Wolny R, Tomasino GF, Berman D, Handberg E, Pepine CJ, Lo MC, Budoff M, Shaw L, Shufelt C, Wei J, Gulati M, Merz CNB, Dey D. Design and rationale of the WARRIOR ancillary study for coronary CT angiographic analysis. Am Heart J. 2026 Apr;294:107340. doi: 10.1016/j.ahj.2026.107340. Epub 2026 Jan 2.
PubMed 41485680
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intensive Medical Treatment on Quantified Coronary Artery Plaque Components With Serial Coronary CTA in Women With NonObstructive CAD
- ClinicalTrials.gov ID
- NCT05035056
- Acronym / sponsor ID
- STUDY00000896
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 5 Sep 2021 (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.
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.
Detailed 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-randomization up to the end of the main WARRIOR study; with changes in plaque and PCAT characteristics quantified.
The main aims are as follows:
- To compare changes in coronary plaque characteristics and their hemodynamic significance using CTA in WARRIOR women treated with IMT vs UC;
- 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;
- 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 randomization to the WARRIOR trial up to study completion; with changes in plaque and CAT characteristics quantified.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT Coronary Angiogram with quantitative characterization of plaque | – | –Participants (102) from Intensive Medical Therapy [IMT] and 102 from the Usual Care [UC] group in the WARRIOR trial) will undergo CTA at the Year 3 follow-up visit (can be as early as 2 years from randomization) at their respective enrollment study sites. Quantitative characterization of plaque analysis will be conducted at Cedars-Sinai Medical Center using Autoplaque plaque analysis software. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This ancillary sub-study will draw 204 patients from the WARRIOR patient group (4422 women), who have undergone a baseline CTA as part of the WARRIOR trial. From this group, 204 patients most compliant with the medication regimen (intensive medical therapy (IMT) with aspirin, statin, angiotensin-converting enzyme inhibitor, and/or angiotensin receptor blocker) vs. usual care (UC) recommended in their treatment groups will undergo a follow-up coronary CTA.
Key inclusion criteria (3 listed)
- 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 total plaque volume >0mm3; women without significant plaque will not receive additional radiation, and we can detect measurable changes in plaque burden and plaque composition.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in atherosclerotic plaque burden and noncalcified plaque composition
Time frame: 3 years
Change in atherosclerotic plaque burden (%) and noncalcified plaque composition (%) using Autoplaque plaque analysis software
Change in coronary plaque inflammation (measured as CT attenuation of Pericoronary adipose tissue)
Time frame: 3 years
Change in pericoronary artery adipose tissue (PCAT) density (CT attenuation of PCAT, in Hounsfield Units) by Autoplaque plaque analysis software
Change in angina score assessed by the Seattle Angina Questionnaire (SAQ)
Time frame: 3 years
Change in angina score quantified by the Seattle Angina Questionnaire (SAQ)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Derived from this study: PubMed 41485680Tamarappoo B, Wolny R, Tomasino GF, Berman D, Handberg E, Pepine CJ, Lo MC, Budoff M, Shaw L, Shufelt C, Wei J, Gulati M, Merz CNB, Dey D. Design and rationale of the WARRIOR ancillary study for coronary CT angiographic analysis. Am Heart J. 2026 Apr;294:107340. doi: 10.1016/j.ahj.2026.107340. Epub 2026 Jan 2.
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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.
Damini Dey, PhD principal investigator
Cedars-Sinai Medical Center
Balaji Tamarappoo, MD principal investigator
Indiana 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 Non-Obstructive Coronary Atherosclerosis, run by Cedars-Sinai Medical Center 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 19 Mar 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in atherosclerotic plaque burden and noncalcified plaque composition (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05035056, which also lists 1 linked publication.
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 19 Mar 2026.