Coronary CT-Derived FFR-Guided Strategy Versus Medical Therapy

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Coronary Computed Tomography-Derived Fraction Flow Reserve (FFR)-Guided Invasive Treatment Strategy (ITS) Versus Optimal Medical Therapy (OMT) Alone in Patient With Chronic Coronary Syndrome

Conditions
-----------------
Coronary Artery Disease, Myocardial Ischaemia

Intervention / Treatment
-----------------
* Other: ITS plus OMT
* Other: OMT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years, with at least one vessel has CT-derived FFR≤0.80 Patients with chronic coronary syndromes Signed written informed consent Exclusion Criteria: The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Contrast media (Patients with documented sensitivity to contrast media which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled) Prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) Sinus arrhythmia, cardiogenic shock, or severe heart failure (NYHA≥III) Inability or unwillingness to undergo CT scan or coronary angiography Patients on hemodialysis or with severe hepatic or renal insufficiency Left main coronary artery stenosis ≥ 50% Target vessel total occlusion Pregnancy or intention to become pregnant during the course of the trial Patients with a life expectancy less than 2 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-derived FFR guided-ITS group<br>CT-derived FFR≤0.8; ITS plus OMT | Other: ITS plus OMT<br>* Invasive treatment strategy plus optimal medical therapy<br>|
| Active Comparator: Medical therapy group<br>CT-derived FFR≤0.8; OMT alone | Other: OMT<br>* Optimal medical therapy alone<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events (MACE) | A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | All-cause death and cardiac death. | 1 year | 
| MI | Target vessel related and non-target vessel related MI. | 1 year | 
| Revascularization | Ischemia driven, non-ischemia driven, target vessel and non-target vessel revascularization. | 1 year | 
| Stroke | Stroke (ischemic and hemorrhagic). | 1 year | 
| Cost-effectiveness analysis | Medical expenses of treatment and follow-up. | 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. | 1 year | 
| MACE | A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization. | 1 month, 2 years, 3 years, 5 years |