The overall purpose of ACCURATE II trial is to compare the clinical outcomes of CT-derived FFR guided strategy versus medical therapy in patients with chronic coronary syndrome.
ACCURATE II is a prospective, multicenter, randomized clinical trial comparing the clinical outcome and cost-effectiveness of the two management strategies. CT-FFR-guided invasive treatment strategy versus optimal medical therapy, in management of patients with chronic coronary syndrome. The study is powered to detect if the primary endpoint by the CT-FFR-guided strategy is superior to the medical therapy strategy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,066
Invasive treatment strategy plus optimal medical therapy
Optimal medical therapy alone
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGMajor adverse cardiac events (MACE)
A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization.
Time frame: 1 year
Death
All-cause death and cardiac death.
Time frame: 1 year
MI
Target vessel related and non-target vessel related MI.
Time frame: 1 year
Revascularization
Ischemia driven, non-ischemia driven, target vessel and non-target vessel revascularization.
Time frame: 1 year
Stroke
Stroke (ischemic and hemorrhagic).
Time frame: 1 year
Cost-effectiveness analysis
Medical expenses of treatment and follow-up.
Time frame: 1 year
Quality of life assessed by Seattle Angina Questionnaire
Frequency of angina and the disease-specific quality of life, as assessed by Seattle Angina Questionnaire.
Time frame: 1 year
MACE
A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization.
Time frame: 1 month, 2 years, 3 years, 5 years
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