Back to resultsCoronary CT-Derived FFR-Guided Strategy Versus Medical Therapy (ACCURATE II)
Primary Purpose
Coronary Artery Disease, Myocardial Ischaemia
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ITS plus OMT
OMT
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
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
Sites / Locations
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CT-derived FFR guided-ITS group
Medical therapy group
Arm Description
CT-derived FFR≤0.8; ITS plus OMT
CT-derived FFR≤0.8; OMT alone
Outcomes
Primary Outcome Measures
Major adverse cardiac events (MACE)
A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization.
Secondary Outcome Measures
Death
All-cause death and cardiac death.
MI
Target vessel related and non-target vessel related MI.
Revascularization
Ischemia driven, non-ischemia driven, target vessel and non-target vessel revascularization.
Stroke
Stroke (ischemic and hemorrhagic).
Cost-effectiveness analysis
Medical expenses of treatment and follow-up.
Quality of life assessed by Seattle Angina Questionnaire
Frequency of angina and the disease-specific quality of life, as assessed by Seattle Angina Questionnaire.
MACE
A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization.
Full Information
NCT ID
NCT05824520
First Posted
March 6, 2023
Last Updated
April 20, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05824520
Brief Title
Coronary CT-Derived FFR-Guided Strategy Versus Medical Therapy
Acronym
ACCURATE II
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 4, 2023 (Anticipated)
Primary Completion Date
May 20, 2025 (Anticipated)
Study Completion Date
May 20, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Myocardial Ischaemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1066 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CT-derived FFR guided-ITS group
Arm Type
Experimental
Arm Description
CT-derived FFR≤0.8; ITS plus OMT
Arm Title
Medical therapy group
Arm Type
Active Comparator
Arm Description
CT-derived FFR≤0.8; OMT alone
Intervention Type
Other
Intervention Name(s)
ITS plus OMT
Intervention Description
Invasive treatment strategy plus optimal medical therapy
Intervention Type
Other
Intervention Name(s)
OMT
Intervention Description
Optimal medical therapy alone
Primary Outcome Measure Information:
Title
Major adverse cardiac events (MACE)
Description
A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Death
Description
All-cause death and cardiac death.
Time Frame
1 year
Title
MI
Description
Target vessel related and non-target vessel related MI.
Time Frame
1 year
Title
Revascularization
Description
Ischemia driven, non-ischemia driven, target vessel and non-target vessel revascularization.
Time Frame
1 year
Title
Stroke
Description
Stroke (ischemic and hemorrhagic).
Time Frame
1 year
Title
Cost-effectiveness analysis
Description
Medical expenses of treatment and follow-up.
Time Frame
1 year
Title
Quality of life assessed by Seattle Angina Questionnaire
Description
Frequency of angina and the disease-specific quality of life, as assessed by Seattle Angina Questionnaire.
Time Frame
1 year
Title
MACE
Description
A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization.
Time Frame
1 month, 2 years, 3 years, 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian'an Wang, MD
Phone
+(86)(571) 87784808
Email
wangjianan111@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian'an Wang, MD
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Jiang, MD
Email
jiang-jun@zju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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Coronary CT-Derived FFR-Guided Strategy Versus Medical Therapy
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