Heartflow Analysis: REWRITE-CAD will provide AI-CPA results
Study 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 which participants are blinded to the AI-CPA results.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. 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)
2. Patients who do not exhibit symptoms suggestive of CAD
3. No other clinical CCTA subsequent to MI/PCI but prior to screening
4. eGFR \>45 mL/min per most recent measurement within 90 days
5. 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
6. 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
7. Ability to provide informed consent
8. Visible plaque in non-stented region on CCTA as assessed by CCTA core lab
9. Acceptable CCTA quality per Heartflow acceptance criteria
Exclusion Criteria:
Non-imaging based
1. Symptoms suggestive of CAD (e.g. stable angina or dyspnea on exertion)
2. On PCSK9i and/or inclisiran at baseline
3. Reduced left ventricular ejection fraction (LVEF) \<35%, if known
4. Prior coronary artery bypass graft (CABG)
5. Prior stents in 2+ vessel territories
6. Life expectancy less than 2 years due to non-CV comorbidities
7. Enrolled in an investigational trial that involves a non-approved cardiac drug or device
8. Previously evaluated with and/or in a trial which includes AI-CPA
9. Any condition that might interfere with trial procedures or follow up visits
10. LDL-C \<70 mg/dL at baseline lab draw
11. Active chemotherapy and/or radiation
Imaging Based (all to be assessed by CCTA core lab)
12. Left Main (LM) ≥50% stenosis on baseline CCTA
13. Proximal LAD FFRct \<0.75
14. Total occlusions in major vessels and/or total occlusion in stent
15. No visible plaque in non-stented segments on CCTA
16. Incidental findings requiring immediate follow-up or management (e.g., Aortic dissection, findings suggestive of cancer, pulmonary embolism)
17. Findings that require further imaging follow-up within 1 year (e.g., pulmonary nodules ≥6 mm)
Primary outcome measure(s)
Percentage of participants who initiate or intensify lipid-lowering therapy (LLT) — Enrollment to 90 days
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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