Coronary CT-Derived FFR-Guided Strategy Versus Medical Therapy (ACCURATE II)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Myocardial Ischaemia
• Intervention / Treatment: Other: ITS plus OMT; Other: OMT

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 Type: Interventional
• Enrollment (Anticipated): 1066
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian'an Wang, MD; Phone Number: +(86)(571) 87784808; Email: wangjianan111@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Jun Jiang, MD; Email: jiang-jun@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Jian'an Wang, MD, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 4, 2023
• Primary Completion (Anticipated): May 20, 2025
• Study Completion (Anticipated): May 20, 2026

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: 2023-0318

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No