[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657120":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":38,"studyPopulation":11,"armGroups":39,"interventions":48,"overallOfficials":11,"centralContacts":54,"locations":63,"responsibleParty":81,"collaborators":83,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":11,"enrollmentInfo":96,"targetDuration":11,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":112,"whyStopped":11,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"HeartFlow, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)",null,"Enrollment to 90 days",[14,16,18,20,22,24,26,28],{"measure":10,"description":11,"timeFrame":15},"Enrollment through end of study at 21 months",{"measure":17,"description":11,"timeFrame":15},"Percentage of participants who initiate or intensify cardiovascular disease prevention medication therapy",{"measure":19,"description":11,"timeFrame":15},"Time to intensification of LLT",{"measure":21,"description":11,"timeFrame":15},"% Undergoing lipid testing",{"measure":23,"description":11,"timeFrame":15},"LDL-C changes",{"measure":25,"description":11,"timeFrame":15},"Changes in Plaque Volumes",{"measure":27,"description":11,"timeFrame":15},"Referral to invasive coronary angiography (ICA) and coronary revascularization",{"measure":29,"description":30,"timeFrame":15},"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 \\\u003C8, and low adherence as \\\u003C6.",{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":11,"timePerspective":11,"maskingInfo":36},"RANDOMIZED","PARALLEL","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.","PREVENTION",{"masking":37,"maskingDescription":11,"whoMasked":11},"NONE","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.",[40,43],{"label":41,"type":42,"description":11,"interventionNames":11},"Usual Care Arm","NO_INTERVENTION",{"label":44,"type":45,"description":11,"interventionNames":46},"Unblinded AI-CPA Test Arm","EXPERIMENTAL",[47],"Device: Heartflow Analysis",[49],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":11},"DEVICE","Heartflow Analysis","REWRITE-CAD will provide AI-CPA results",[44],[55,60],{"name":56,"role":57,"phone":58,"phoneExt":11,"email":59},"Whitney Huey","CONTACT","877-478-3569","whuey@heartflow.com",{"name":61,"role":57,"phone":58,"phoneExt":11,"email":62},"Zachary Sterner, Ph.D","zsterner@heartflow.com",[64],{"facility":65,"status":11,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"REWRITE-CAD Trial Site","Greensboro","North Carolina","27401","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-79.79198,36.07264,{"lat":75,"lon":74},[78],{"name":79,"role":57,"phone":58,"phoneExt":11,"email":80},"Heartflow Investigator","rewrite-cad@heartflow.com",{"type":82,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[84],{"name":85,"class":6},"Avania","100657120","rewrite-cad-protocol-risk-evaluation-with-ai-cpa-to-reduce-progression-and-improve-lifetime-care-for-patients-with-known-coronary-artery-disease-100657120",false,"NCT07834372","REWRITE-CAD Protocol: Risk Evaluation With AI-CPA to Reduce Progression and Improve Lifetime Care for Patients With Known Coronary Artery Disease","Risk Evaluation With AI-CPA to Reduce Progression and Improve Lifetime Care for Patients With Known Coronary Artery Disease","REWRITE-CAD","Inclusion Criteria:\n\n1. History of PCI (1 year - 5 years prior to Day 0) and\u002For history of MI (Type I or II) (1 year - 5 years prior to Day 0)\n2. Patients who do not exhibit symptoms suggestive of CAD\n3. No other clinical CCTA subsequent to MI\u002FPCI but prior to screening\n4. eGFR \\>45 mL\u002Fmin per most recent measurement within 90 days\n5. 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\n6. 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\n7. Ability to provide informed consent\n8. Visible plaque in non-stented region on CCTA as assessed by CCTA core lab\n9. Acceptable CCTA quality per Heartflow acceptance criteria\n\nExclusion Criteria:\n\nNon-imaging based\n\n1. Symptoms suggestive of CAD (e.g. stable angina or dyspnea on exertion)\n2. On PCSK9i and\u002For inclisiran at baseline\n3. Reduced left ventricular ejection fraction (LVEF) \\\u003C35%, if known\n4. Prior coronary artery bypass graft (CABG)\n5. Prior stents in 2+ vessel territories\n6. Life expectancy less than 2 years due to non-CV comorbidities\n7. Enrolled in an investigational trial that involves a non-approved cardiac drug or device\n8. Previously evaluated with and\u002For in a trial which includes AI-CPA\n9. Any condition that might interfere with trial procedures or follow up visits\n10. LDL-C \\\u003C70 mg\u002FdL at baseline lab draw\n11. Active chemotherapy and\u002For radiation\n\n    Imaging Based (all to be assessed by CCTA core lab)\n12. Left Main (LM) ≥50% stenosis on baseline CCTA\n13. Proximal LAD FFRct \\\u003C0.75\n14. Total occlusions in major vessels and\u002For total occlusion in stent\n15. No visible plaque in non-stented segments on CCTA\n16. Incidental findings requiring immediate follow-up or management (e.g., Aortic dissection, findings suggestive of cancer, pulmonary embolism)\n17. Findings that require further imaging follow-up within 1 year (e.g., pulmonary nodules ≥6 mm)","ALL","18 Years",{"count":97,"type":98},350,"ESTIMATED","INTERVENTIONAL",[101],"NA","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.",[104],"CAD - Coronary Artery Disease",[106,107,108,109,110,111],"CAD","AI-CPA","CCTA","PCI","MI","Coronary Plaque","NOT_YET_RECRUITING","2026-09-16",{"date":115,"type":116},"2026-09-22","ACTUAL",{"date":118,"type":98},"2026-10",{"date":120,"type":98},"2029-04",{"name":5,"class":6},1]