Coronary CT-Derived FFR-Guided Strategy Versus Medical Therapy

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05824520
• Other study ID #: 2023-0318
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 4, 2023
• Est. completion date: May 20, 2026

Study information

• Verified date: April 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jian'an Wang, MD
• Phone: +(86)(571) 87784808
• Email: wangjianan111[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1066
• Est. completion date: May 20, 2026
• Est. primary completion date: May 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• Myocardial Ischaemia
• Myocardial Ischemia

Intervention

Other:
• ITS plus OMT
Invasive treatment strategy plus optimal medical therapy
• OMT
Optimal medical therapy alone

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

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