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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
350
REWRITE-CAD will provide AI-CPA results
REWRITE-CAD Trial Site
Greensboro, North Carolina, United States
Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)
Time frame: Enrollment to 90 days
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)
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.
Time frame: Enrollment through end of study at 21 months
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