REWRITE-CAD Protocol: Risk Evaluation With AI-CPA to Reduce Progression and Improve Lifetime Care for Patients With Known Coronary Artery Disease

NCT07834372 | Not Yet Recruiting FDA Device

• 1 other identifier: CP-912-001
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CAD - Coronary Artery Disease

Keywords

CAD; AI-CPA; CCTA; PCI; MI; Coronary Plaque

Outcome Measures

Primary Outcomes (1)

• Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)

  Enrollment to 90 days

Secondary Outcomes (8)

• Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)

  Enrollment through end of study at 21 months

• Percentage of participants who initiate or intensify cardiovascular disease prevention medication therapy

  Enrollment through end of study at 21 months

• Time to intensification of LLT

  Enrollment through end of study at 21 months

• % Undergoing lipid testing

  Enrollment through end of study at 21 months

• LDL-C changes

  Enrollment through end of study at 21 months

Study Arms (2)

Usual Care Arm

NO INTERVENTION

Unblinded AI-CPA Test Arm

EXPERIMENTAL

Device: Heartflow Analysis

Interventions

Heartflow Analysis DEVICE

REWRITE-CAD will provide AI-CPA results

Unblinded AI-CPA Test Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• HeartFlow, Inc.: lead
• Avania: collaborator

Study Sites (1)

REWRITE-CAD Trial Site

Greensboro, North Carolina, 27401, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Whitney Huey

CONTACT

877-478-3569; whuey@heartflow.com

Zachary Sterner, Ph.D

CONTACT

877-478-3569; zsterner@heartflow.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 22, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): April 1, 2029
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)