Coronary CT-Derived FFR-Guided Strategy Versus Medical Therapy

NCT05824520 | Recruiting DMC

• 1 other identifier: 2023-0318
• Study Type: interventional
• Target: 1,066
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Myocardial Ischaemia

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac events (MACE)

  A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization.

  1 year

Secondary Outcomes (7)

• Death

  1 year

• MI

  1 year

• Revascularization

  1 year

• Stroke

  1 year

• Cost-effectiveness analysis

  1 year

Study Arms (2)

CT-derived FFR guided-ITS group

EXPERIMENTAL

CT-derived FFR≤0.8; ITS plus OMT

Other: ITS plus OMT

Medical therapy group

ACTIVE COMPARATOR

CT-derived FFR≤0.8; OMT alone

Other: OMT

Interventions

ITS plus OMT OTHER

Invasive treatment strategy plus optimal medical therapy

CT-derived FFR guided-ITS group

OMT OTHER

Optimal medical therapy alone

Medical therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, with at least one vessel has CT-derived FFR≤0.80
• Patients with chronic coronary syndromes
• Signed written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jian'an Wang, MD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian'an Wang, MD

CONTACT

+(86)(571) 87784808; wangjianan111@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 21, 2023
• Study Start: October 10, 2024
• Primary Completion (Estimated): October 20, 2028
• Study Completion (Estimated): October 20, 2032
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)