CAD - Coronary Artery DiseaseREWRITE-CADNCT07834372
REWRITE-CAD Protocol: Risk Evaluation With AI-CPA to Reduce Progression and Improve Lifetime Care for Patients With Known Coronary Artery Disease
A study testing Heartflow Analysis in people with CAD - Coronary Artery Disease, run by HeartFlow, Inc. at 1 site in United States.
Trial summary
REWRITE-CAD is a prospective, randomized, multi-center trial assessing the management of asymptomatic participants with a history of PCI or MI who will undergo a blinded CCTA and be randomly assigned to either the test arm in which participants receive the unblinded results of Heartflow AI-CPA or the usual care arm in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CAD - Coronary Artery Disease
- What is being tested?
- Heartflow Analysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of PCI (1 year - 5 years prior to Day 0) and/or history of MI (Type I or II) (1 year - 5 years prior to Day 0)
- Patients who do not exhibit symptoms suggestive of CAD
- No other clinical CCTA subsequent to MI/PCI but prior to screening
- eGFR >45 mL/min per most recent measurement within 90 days
- Willingness to comply with all aspects of the protocol including research CCTAs, lab draws, medication adherence assessments, attending all study visits, and the ability to comply with prescribed medications
- For a female participant of childbearing potential (those who have not been surgically sterilized), a pregnancy test must be performed with negative results known within 7 days prior to randomization
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- Ability to provide informed consent
- Visible plaque in non-stented region on CCTA as assessed by CCTA core lab
- Acceptable CCTA quality per Heartflow acceptance criteria
Who cannot join
- Non-imaging based
- Symptoms suggestive of CAD (e.g. stable angina or dyspnea on exertion)
- On PCSK9i and/or inclisiran at baseline
- Reduced left ventricular ejection fraction (LVEF) <35%, if known
- Prior coronary artery bypass graft (CABG)
- Prior stents in 2+ vessel territories
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- Life expectancy less than 2 years due to non-CV comorbidities
- Enrolled in an investigational trial that involves a non-approved cardiac drug or device
- Previously evaluated with and/or in a trial which includes AI-CPA
- Any condition that might interfere with trial procedures or follow up visits
- LDL-C <70 mg/dL at baseline lab draw
- Active chemotherapy and/or radiation
- Imaging Based (all to be assessed by CCTA core lab)
- Left Main (LM) ≥50% stenosis on baseline CCTA
- Proximal LAD FFRct <0.75
- Total occlusions in major vessels and/or total occlusion in stent
- No visible plaque in non-stented segments on CCTA
- Incidental findings requiring immediate follow-up or management (e.g., Aortic dissection, findings suggestive of cancer, pulmonary embolism)
- Findings that require further imaging follow-up within 1 year (e.g., pulmonary nodules ≥6 mm)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
REWRITE-CAD Trial Site
Greensboro, North Carolina, 27401
Heartflow Investigator, 877-478-3569, rewrite-cad@heartflow.com
About this study
Official title: Risk Evaluation With AI-CPA to Reduce Progression and Improve Lifetime Care for Patients With Known Coronary Artery Disease
REWRITE-CAD is a prospective, randomized, multi-center trial assessing the management of asymptomatic participants with a history of PCI or MI who will undergo a blinded CCTA and be randomly assigned to either the test arm in which participants receive the unblinded results of Heartflow AI-CPA or the usual care arm in which participants are blinded to the AI-CPA results.
Read the detailed description
The objective of the REWRITE-CAD trial is to assess changes in lipid lowering therapy over time in participants with a history of PCI or MI who undergo a blinded CCTA and are randomly assigned to either the test arm in which participants will undergo a blinded CCTA and receive the unblinded Heartflow AI-CPA results or the usual care arm in which participants will undergo a blinded CCTA with blinded AI-CPA results.
- Conditions
- CAD - Coronary Artery Disease
- Being tested
- Heartflow Analysis
- Keywords
- CAD, AI-CPA, CCTA, PCI, MI, Coronary Plaque
- 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.
Heartflow AnalysisDevice
REWRITE-CAD will provide AI-CPA results
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Arm | No intervention | Not described |
| Unblinded AI-CPA Test Arm | Experimental | Not described Receives: Device: Heartflow Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)
Measured: Enrollment to 90 days
Secondary outcomes (8)
Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)
Measured: Enrollment through end of study at 21 months
Percentage of participants who initiate or intensify cardiovascular disease prevention medication therapy
Measured: Enrollment through end of study at 21 months
Time to intensification of LLT
Measured: Enrollment through end of study at 21 months
% Undergoing lipid testing
Measured: Enrollment through end of study at 21 months
LDL-C changes
Measured: Enrollment through end of study at 21 months
Changes in Plaque Volumes
Measured: Enrollment through end of study at 21 months
Referral to invasive coronary angiography (ICA) and coronary revascularization
Measured: Enrollment through end of study at 21 months
Percentage of participants classified as high adherence on the 8-item Morisky Medication Adherence Scale (MMAS-8)
Evaluated using the 8-item MMAS-8 questionnaire. Total scores range from 0 to 8, where higher scores indicate better adherence. High adherence is defined as achieving a score of 8, medium adherence as 6 to <8, and low adherence as <6.
Measured: Enrollment through end of study at 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAD - 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized using a 1:1 randomization scheme via an interactive web or voice-based system (IXRS). Randomization will occur into one of two arms: the test arm test arm in which participants will undergo a blinded CCTA and receive unblinded Heartflow AI-CPA or the usual care arm in which participants will undergo a blinded CCTA with blinded AI-CPA.
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HeartFlow, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834372
- Sponsor's protocol ID
- CP-912-001
- Acronym
- REWRITE-CAD
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Evaluation With AI-CPA to Reduce Progression and Improve Lifetime Care for Patients With Known Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT07834372
- Acronym / sponsor ID
- REWRITE-CAD / CP-912-001
- Conditions
- CAD - Coronary Artery Disease
- Keywords
- CAD, AI-CPA, CCTA, PCI, MI, Coronary Plaque
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- HeartFlow, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 22 Sep 2026 (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.
REWRITE-CAD is a prospective, randomized, multi-center trial assessing the management of asymptomatic participants with a history of PCI or MI who will undergo a blinded CCTA and be randomly assigned to either the test arm in which participants receive the unblinded results of Heartflow AI-CPA or the usual care arm in which participants are blinded to the AI-CPA results.
Detailed description
The objective of the REWRITE-CAD trial is to assess changes in lipid lowering therapy over time in participants with a history of PCI or MI who undergo a blinded CCTA and are randomly assigned to either the test arm in which participants will undergo a blinded CCTA and receive the unblinded Heartflow AI-CPA results or the usual care arm in which participants will undergo a blinded CCTA with blinded AI-CPA results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized using a 1:1 randomization scheme via an interactive web or voice-based system (IXRS). Randomization will occur into one of two arms: the test arm test arm in which participants will undergo a blinded CCTA and receive unblinded Heartflow AI-CPA or the usual care arm in which participants will undergo a blinded CCTA with blinded AI-CPA.
| Arm | Type | Receives |
|---|---|---|
| Usual Care Arm | No intervention | – |
| Unblinded AI-CPA Test Arm | Experimental | Device: Heartflow Analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- History of PCI (1 year - 5 years prior to Day 0) and/or history of MI (Type I or II) (1 year - 5 years prior to Day 0)
- Patients who do not exhibit symptoms suggestive of CAD
- No other clinical CCTA subsequent to MI/PCI but prior to screening
- eGFR >45 mL/min per most recent measurement within 90 days
- Willingness to comply with all aspects of the protocol including research CCTAs, lab draws, medication adherence assessments, attending all study visits, and the ability to comply with prescribed medications
Key exclusion criteria (19 listed)
- Non-imaging based
- Symptoms suggestive of CAD (e.g. stable angina or dyspnea on exertion)
- On PCSK9i and/or inclisiran at baseline
- Reduced left ventricular ejection fraction (LVEF) <35%, if known
- Prior coronary artery bypass graft (CABG)
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 |
|---|---|---|
| Heartflow AnalysisREWRITE-CAD will provide AI-CPA results | Device | Unblinded AI-CPA Test Arm |
Primary outcome
Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)
Time frame: Enrollment to 90 days
8 secondary outcomes
Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)
Time frame: Enrollment through end of study at 21 months
Percentage of participants who initiate or intensify cardiovascular disease prevention medication therapy
Time frame: Enrollment through end of study at 21 months
Time to intensification of LLT
Time frame: Enrollment through end of study at 21 months
% Undergoing lipid testing
Time frame: Enrollment through end of study at 21 months
LDL-C changes
Time frame: Enrollment through end of study at 21 months
Changes in Plaque Volumes
Time frame: Enrollment through end of study at 21 months
Referral to invasive coronary angiography (ICA) and coronary revascularization
Time frame: Enrollment through end of study at 21 months
Percentage of participants classified as high adherence on the 8-item Morisky Medication Adherence Scale (MMAS-8)
Time frame: Enrollment through end of study at 21 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heartflow Analysis in people with CAD - Coronary Artery Disease, run by HeartFlow, Inc. 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 9 inclusion and 19 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: opening soon, as of the sponsor's last update on 22 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Whitney Huey (877-478-3569, whuey@heartflow.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who initiate or intensify lipid-lowering therapy (LLT) (time frame: Enrollment to 90 days). 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 22 Sep 2026.