Coronary CT-Derived FFR-Guided Strategy Versus Medical Therapy

NCT ID: NCT05824520

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1066 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-10
• Study Completion Date: 2032-10-20

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.

Conditions

Coronary Artery Disease; Myocardial Ischaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CT-derived FFR guided-ITS group

CT-derived FFR≤0.8; ITS plus OMT

Group Type: EXPERIMENTAL

ITS plus OMT

Intervention Type: OTHER

Invasive treatment strategy plus optimal medical therapy

Medical therapy group

CT-derived FFR≤0.8; OMT alone

Group Type: ACTIVE_COMPARATOR

OMT

Intervention Type: OTHER

Optimal medical therapy alone

Interventions

ITS plus OMT

Invasive treatment strategy plus optimal medical therapy

Intervention Type: OTHER

OMT

Optimal medical therapy alone

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian'an Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jian'an Wang, MD

Role: CONTACT

wangjianan111@zju.edu.cn

+(86)(571) 87784808

Facility Contacts

Jun Jiang, MD

Role: primary

jiang-jun@zju.edu.cn

Other Identifiers

2023-0318

Identifier Type: -

Identifier Source: org_study_id