Coronary CT-Derived FFR-Guided Strategy Versus Medical Therapy

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease; Myocardial Ischaemia
• Interventions: Other: OMT; Other: ITS plus OMT

• Registration Number: NCT05824520
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Study First Submitted: 2023-03-06
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-20
• Last Update Submitted: 2023-04-20
• Study First Posted: 2023-04-21
• Last Update Posted: 2023-04-21
• Study Start: 2023-05-04
• Primary Completion: 2025-05-20
• Study Completion: 2026-05-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1066

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical therapy group	OMT	CT-derived FFR≤0.8; OMT alone
CT-derived FFR guided-ITS group	ITS plus OMT	CT-derived FFR≤0.8; ITS plus OMT

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events (MACE)	1 year	A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization.

Secondary Outcome Measures

Name	Time	Method
Stroke	1 year	Stroke (ischemic and hemorrhagic).
Death	1 year	All-cause death and cardiac death.
Revascularization	1 year	Ischemia driven, non-ischemia driven, target vessel and non-target vessel revascularization.
MACE	1 month, 2 years, 3 years, 5 years	A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization.
Cost-effectiveness analysis	1 year	Medical expenses of treatment and follow-up.
MI	1 year	Target vessel related and non-target vessel related MI.
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.

Trial Locations

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China