ACCURATE II: Coronary CT-Derived FFR-Guided Strategy Versus Medical Therapy
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CT-derived FFR guided-ITS group CT-derived FFR≤0.8; ITS plus OMT |
Other: ITS plus OMT
Invasive treatment strategy plus optimal medical therapy
|
| Active Comparator: Medical therapy group CT-derived FFR≤0.8; OMT alone |
Other: OMT
Optimal medical therapy alone
|
Outcome Measures
Primary Outcome Measures
- Major adverse cardiac events (MACE) [1 year]
A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization.
Secondary Outcome Measures
- Death [1 year]
All-cause death and cardiac death.
- MI [1 year]
Target vessel related and non-target vessel related MI.
- Revascularization [1 year]
Ischemia driven, non-ischemia driven, target vessel and non-target vessel revascularization.
- Stroke [1 year]
Stroke (ischemic and hemorrhagic).
- Cost-effectiveness analysis [1 year]
Medical expenses of treatment and follow-up.
- Quality of life assessed by Seattle Angina Questionnaire [1 year]
Frequency of angina and the disease-specific quality of life, as assessed by Seattle Angina Questionnaire.
- MACE [1 month, 2 years, 3 years, 5 years]
A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization.
Eligibility Criteria
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)
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Sinus arrhythmia, cardiogenic shock, or severe heart failure (NYHA≥III)
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Inability or unwillingness to undergo CT scan or coronary angiography
-
Patients on hemodialysis or with severe hepatic or renal insufficiency
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | China | 310009 |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
- Principal Investigator: Jian'an Wang, MD, Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-0318