Coronary Artery DiseaseACCURATE IINCT05824520
Coronary CT-Derived FFR-Guided Strategy Versus Medical Therapy
A study testing ITS plus OMT and OMT in people with Coronary Artery Disease and Myocardial Ischaemia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Ischaemia
- What is being tested?
- ITS plus OMT and OMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,066 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2024to 20 Oct 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, with at least one vessel has CT-derived FFR≤0.80
- Patients with chronic coronary syndromes
- Signed written informed consent
Who cannot join
- 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%
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Jun Jiang, MD, jiang-jun@zju.edu.cn
About this study
Official 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
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.
Read the 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
- Being tested
- ITS plus OMT, OMT
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITS plus OMTOther
Invasive treatment strategy plus optimal medical therapy
OMTOther
Optimal medical therapy alone
| Study group | Role | What they receive |
|---|---|---|
| CT-derived FFR guided-ITS group | Experimental | CT-derived FFR≤0.8; ITS plus OMT Receives: Other: ITS plus OMT |
| Medical therapy group | Active comparator | CT-derived FFR≤0.8; OMT alone Receives: Other: OMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events (MACE)
A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization.
Measured: 1 year
Secondary outcomes (7)
Death
All-cause death and cardiac death.
Measured: 1 year
MI
Target vessel related and non-target vessel related MI.
Measured: 1 year
Revascularization
Ischemia driven, non-ischemia driven, target vessel and non-target vessel revascularization.
Measured: 1 year
Stroke
Stroke (ischemic and hemorrhagic).
Measured: 1 year
Cost-effectiveness analysis
Medical expenses of treatment and follow-up.
Measured: 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.
Measured: 1 year
MACE
A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization.
Measured: 1 month, 2 years, 3 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start10 Oct 2024
- Primary completion20 Oct 2028 (estimated)
- Study completion20 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,066 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian'an Wang, MD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824520
- Sponsor's protocol ID
- 2023-0318
- Acronym
- ACCURATE II
- Status last verified
- Jan 2026
- First submitted
- 6 Mar 2023
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05824520
- Acronym / sponsor ID
- ACCURATE II / 2023-0318
- Conditions
- Coronary Artery Disease, Myocardial Ischaemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,066 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 20 Oct 2028 (estimated)
- Study completion
- 20 Oct 2032 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-derived FFR guided-ITS group | Experimental | Other: ITS plus OMTCT-derived FFR≤0.8; ITS plus OMT |
| Medical therapy group | Active comparator | Other: OMTCT-derived FFR≤0.8; OMT alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years, with at least one vessel has CT-derived FFR≤0.80
- Patients with chronic coronary syndromes
- Signed written informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITS plus OMTInvasive treatment strategy plus optimal medical therapy | Other | CT-derived FFR guided-ITS group |
| OMTOptimal medical therapy alone | Other | Medical therapy group |
Primary outcome
Major adverse cardiac events (MACE)
Time frame: 1 year
A composite of all-cause death, myocardial infarction (MI) or ischemia-driven revascularization.
7 secondary outcomes
Death
Time frame: 1 year
MI
Time frame: 1 year
Revascularization
Time frame: 1 year
Stroke
Time frame: 1 year
Cost-effectiveness analysis
Time frame: 1 year
Quality of life assessed by Seattle Angina Questionnaire
Time frame: 1 year
MACE
Time frame: 1 month, 2 years, 3 years, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian'an Wang, MD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ITS plus OMT and OMT in people with Coronary Artery Disease and Myocardial Ischaemia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian'an Wang, MD (+(86)(571) 87784808, wangjianan111@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (MACE) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.