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NCT Number: NCT05824520

Coronary CT-Derived FFR-Guided Strategy Versus Medical Therapy

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

Jun Jiang, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ITS plus OMT

Other

Invasive treatment strategy plus optimal medical therapy

OMT

Other

Optimal medical therapy alone

Primary outcomes

  1. Major adverse cardiac events (MACE)

    Time frame: 1 year

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

Secondary outcomes

  1. Death

    Time frame: 1 year

    All-cause death and cardiac death.

  2. MI

    Time frame: 1 year

    Target vessel related and non-target vessel related MI.

  3. Revascularization

    Time frame: 1 year

    Ischemia driven, non-ischemia driven, target vessel and non-target vessel revascularization.

  4. Stroke

    Time frame: 1 year

    Stroke (ischemic and hemorrhagic).

  5. Cost-effectiveness analysis

    Time frame: 1 year

    Medical expenses of treatment and follow-up.

  6. Quality of life assessed by Seattle Angina Questionnaire

    Time frame: 1 year

    Frequency of angina and the disease-specific quality of life, as assessed by Seattle Angina Questionnaire.

  7. MACE

    Time frame: 1 month, 2 years, 3 years, 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jian'an Wang, MD

CONTACT

[email protected]

+(86)(571) 87784808

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study 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

Acronym: ACCURATE II

Important dates

Study start
2024
Primary completion
2028
Study completion
2032
First posted
Apr 21, 2023
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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