Coronary Artery Disease(CAD)Phase 3NCT07439133
Comparison of Diagnostic Accuracy Between XTR004 PET MPI and the Composite Index of Quantitative Coronary Angiography (QCA) and Fractional Flow Reserve (FFR)
A Phase 3 study testing XTR004 in people with Coronary Artery Disease(CAD), run by Sinotau Pharmaceutical Group at 5 sites in China.
Trial summary
The primary objective of this study is to evaluate the effectiveness of visual reading in XTR004 PET myocardial perfusion imaging (MPI) for detecting restrictive stenosis, using quantitative coronary angiography (QCA) and fractional flow reserve (FFR) as reference standards in patients with suspected or known coronary… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease(CAD)
- What is being tested?
- XTR004
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 395 participants
- Where
- 5 sitesChina
- Study dates
- 14 Nov 2025to Oct 2027
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 18 to 80 years, male or female.
- Suspected or confirmed patients with stable coronary heart disease. Those suspected of having stable coronary heart disease must meet at least one of the following risk factors: hypertension, hyperlipidemia, diabetes, obesity (BMI ≥28), a history of alcohol abuse, a smoking history, a family history of coronary heart disease, postmenopausal status, or age 60 years or older.
- Participants can communicate well with investigators, understand and comply with clinical trial requirements, voluntarily participate in the study, and sign an informed consent form.
Who cannot join
- Participants with severe cardiovascular diseases, including but not limited to unstable angina (Canadian Cardiac Society (CCS) Grade III/IV angina pectoris), uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and/or diastolic ≥110 mmHg despite long-term regular antihypertensive medication), hypotension (resting systolic blood pressure <90 mmHg), acute myocardial infarction, second or third-degree atrioventricular block, sinoatrial node disease, NYHA Class III/IV heart failure, dilated or hypertrophic cardiomyopathy, pericarditis, valvular heart disease, aortic dissection, uncontrolled severe arrhythmias, congenital heart disease, those who have undergone coronary artery bypass grafting or interventional procedures within three months, and those determined unsuitable for participation in this study by investigators;
- Participants with severe acute or chronic pulmonary diseases (including but not limited to COPD, asthma, bronchiectasis, emphysema, pulmonary fibrosis, pulmonary embolism, pneumonia, etc.) who are determined unsuitable for participation by the investigator;
- Participants with severe or unstable central nervous system disorders (including but not limited to unstable cerebrovascular diseases, active epilepsy, CNS infections, CNS diseases accompanied by mental disorders or motor impairments) who are determined unsuitable for participation by the investigator;
- Participants with severe bleeding disorders or coagulation dysfunction (including but not limited to purpura, hemophilia, vitamin K deficiency, etc.) who are determined unsuitable for participation by the investigator;
- Participants with severe liver dysfunction (including but not limited to viral hepatitis, autoimmune hepatitis, cirrhosis, liver cancer, etc.) who are determined unsuitable for participation by the investigator;
- Participants with severe kidney impairment (including but not limited to glomerulonephritis, renal insufficiency, nephrotic syndrome, membranous nephropathy, hydronephrosis, renal cystopathy, etc.) who are determined unsuitable for participation by the investigator;
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- Participants with fever or active infectious diseases who are determined unsuitable for participation by the investigator;
- Participants with known alcohol allergy who are determined unsuitable for participation by the investigator;
- participants with known adenosine allergy who are determined unsuitable for participation by the investigator;
- Participants with known iodine contrast agent allergy who are determined unsuitable for participation by the investigator;
- Within the past 10 years, significant occupational exposure to ionizing radiation (e.g., exceeding 50 mSv/year) or exposure to radioactive substances or ionizing radiation for therapeutic/research purposes;
- Male or women of childbearing age not using effective contraception during study participation and within 6 months post-study (effective contraception refers to sterilization, intrauterine device, condoms, abstinence, or surgical blockage of vas deferens/fallopian tubes);
- Female participants in pregnancy or lactation
- Individuals with claustrophobia, bipolar disorder, mental disorders, or poor compliance;
- Participation in other investigational drug trials within 30 days prior to enrollment or planned during study;
- Any other circumstances determined unsuitable by investigators.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing
- Recruiting
Beijing Tongren Hospital
Beijing
- Recruiting
Peking Union Medical College Hospital
Beijing
- Recruiting
The First People's Hospital of Foshan
Foshan
- Recruiting
TEDA International Cardiovascular Hospital
Tianjin
About this study
Official title: Evaluation of the Efficacy and Safety of XTR004 Injection in Detecting Blood Flow Restrictive Stenosis in Patients With Suspected or Known Stable Coronary Artery Disease: A Multicenter, Open-Label, Phase III Clinical Trial
The primary objective of this study is to evaluate the effectiveness of visual reading in XTR004 PET myocardial perfusion imaging (MPI) for detecting restrictive stenosis, using quantitative coronary angiography (QCA) and fractional flow reserve (FFR) as reference standards in patients with suspected or known coronary artery disease.
- Conditions
- Coronary Artery Disease(CAD)
- Being tested
- XTR004
- 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.
XTR004Drug
Also called Drug: 99mTechnicium Sestamibi, Procedure: Coronary angiography
XTR004 as the experiemental drug, 99mTechnetium Sestamibi as the Active Comparator, and Coronary artery angiography as the refenrece standard
| Study group | Role | What they receive |
|---|---|---|
| enrolled participants with suspected or known CAD | Experimental | Not described Receives: Drug: XTR004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Efficacy of XTR004 PET myocardial perfusion imaging (MPI) for detecting restrictive stenosis, using quantitative coronary angiography (QCA) and fractional flow reserve (FFR) as reference standards
Sensitivity and specificity of XTR004 PET myocardial perfusion imaging (MPI) for detecting restrictive stenosis, using quantitative coronary angiography (QCA) and fractional flow reserve (FFR) as reference standards
Measured: 60 days
Secondary outcomes (6)
To evaluate the differences in diagnostic efficacy between XTR004 PET MPI and MIBI SPECT MPI in detecting restrictive stenosis
Sensitivity and specificity of XTR004 PET MPI and MIBI SPECT MPI in detecting restrictive stenosis
Measured: 60 days
To assess differences in image quality and diagnostic certainty between XTR004 PET MPI and MIBI SPECT MPI
Overall summary of image quality and diagnostic certainty of XTR004 PET MPI and MIBI SPECT MPI
Measured: 60 days
To validate the effectiveness of semi-quantitative analysis in XTR004 PET MPI for the detection of restrictive stenosis
Overall summary of the sensitivity and specificity of semi-quantitative analysis in XTR004 PET MPI for the detection of restrictive stenosis
Measured: 60 days
To evaluate the diagnostic efficacy of XTR004 PET MPI in different subgroups
Sensitivity and specificcity of XTR004 PET MPI in detection of flow-limiting stenosis in different subgroups, including subjects with different stenosis degrees detected by CTA, female, BMI ≥30kg/m2, and subjects with diabetes
Measured: 60 days
To compare the differences in diagnostic performance between XTR004 PET MPI and MIBI SPECT MPI using QCA results as a reference standard
Overall summary of diagnostic efficacy of XTR004 PET MPI and MIBI SPECT MPI using QCA results as a reference standard
Measured: 60 days
Number of participants with treatment-related adverse events, severe adverse events as assessed by CTCAE v5.0
To assess the safety in subjects with suspected or confirmed stable coronary artery disease after two consecutive intravenous bolus injections of XTR004 solution
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start14 Nov 2025
- Primary completionJun 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease(CAD)Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 395 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinotau Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439133
- Sponsor's protocol ID
- STB-XTR004-301
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of XTR004 Injection in Detecting Blood Flow Restrictive Stenosis in Patients With Suspected or Known Stable Coronary Artery Disease: A Multicenter, Open-Label, Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT07439133
- Acronym / sponsor ID
- STB-XTR004-301
- Conditions
- Coronary Artery Disease(CAD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 395 participants (estimated)
- Lead sponsor
- Sinotau Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 27 Feb 2026 (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 primary objective of this study is to evaluate the effectiveness of visual reading in XTR004 PET myocardial perfusion imaging (MPI) for detecting restrictive stenosis, using quantitative coronary angiography (QCA) and fractional flow reserve (FFR) as reference standards in patients with suspected or known coronary artery disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| enrolled participants with suspected or known CAD | Experimental | Drug: XTR004 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants aged 18 to 80 years, male or female.
- Suspected or confirmed patients with stable coronary heart disease. Those suspected of having stable coronary heart disease must meet at least one of the following risk factors: hypertension, hyperlipidemia, diabetes, obesity (BMI ≥28), a history of alcohol abuse, a smoking history, a family history of coronary heart disease, postmenopausal status, or age 60 years or older.
- Participants can communicate well with investigators, understand and comply with clinical trial requirements, voluntarily participate in the study, and sign an informed consent form.
Key exclusion criteria (16 listed)
- Participants with severe cardiovascular diseases, including but not limited to unstable angina (Canadian Cardiac Society (CCS) Grade III/IV angina pectoris), uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and/or diastolic ≥110 mmHg despite long-term regular antihypertensive medication), hypotension (resting systolic blood pressure <90 mmHg), acute myocardial infarction, second or third-degree atrioventricular block, sinoatrial node disease, NYHA Class III/IV heart failure, dilated or hypertrophic cardiomyopathy, pericarditis, valvular heart disease, aortic dissection, uncontrolled severe arrhythmias, congenital heart disease, those who have undergone coronary artery bypass grafting or interventional procedures within three months, and those determined unsuitable for participation in this study by investigators;
- Participants with severe acute or chronic pulmonary diseases (including but not limited to COPD, asthma, bronchiectasis, emphysema, pulmonary fibrosis, pulmonary embolism, pneumonia, etc.) who are determined unsuitable for participation by the investigator;
- Participants with severe or unstable central nervous system disorders (including but not limited to unstable cerebrovascular diseases, active epilepsy, CNS infections, CNS diseases accompanied by mental disorders or motor impairments) who are determined unsuitable for participation by the investigator;
- Participants with severe bleeding disorders or coagulation dysfunction (including but not limited to purpura, hemophilia, vitamin K deficiency, etc.) who are determined unsuitable for participation by the investigator;
- Participants with severe liver dysfunction (including but not limited to viral hepatitis, autoimmune hepatitis, cirrhosis, liver cancer, etc.) who are determined unsuitable for participation by the investigator;
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 |
|---|---|---|
| XTR004Also: Drug: 99mTechnicium Sestamibi, Procedure: Coronary angiographyXTR004 as the experiemental drug, 99mTechnetium Sestamibi as the Active Comparator, and Coronary artery angiography as the refenrece standard | Drug | enrolled participants with suspected or known CAD |
Primary outcome
Diagnostic Efficacy of XTR004 PET myocardial perfusion imaging (MPI) for detecting restrictive stenosis, using quantitative coronary angiography (QCA) and fractional flow reserve (FFR) as reference standards
Time frame: 60 days
Sensitivity and specificity of XTR004 PET myocardial perfusion imaging (MPI) for detecting restrictive stenosis, using quantitative coronary angiography (QCA) and fractional flow reserve (FFR) as reference standards
6 secondary outcomes
To evaluate the differences in diagnostic efficacy between XTR004 PET MPI and MIBI SPECT MPI in detecting restrictive stenosis
Time frame: 60 days
To assess differences in image quality and diagnostic certainty between XTR004 PET MPI and MIBI SPECT MPI
Time frame: 60 days
To validate the effectiveness of semi-quantitative analysis in XTR004 PET MPI for the detection of restrictive stenosis
Time frame: 60 days
To evaluate the diagnostic efficacy of XTR004 PET MPI in different subgroups
Time frame: 60 days
To compare the differences in diagnostic performance between XTR004 PET MPI and MIBI SPECT MPI using QCA results as a reference standard
Time frame: 60 days
Number of participants with treatment-related adverse events, severe adverse events as assessed by CTCAE v5.0
Time frame: 60 days
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 3 Mar 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing XTR004 in people with Coronary Artery Disease(CAD), run by Sinotau Pharmaceutical Group at 5 sites 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 16 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 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 LING YUAN (010-80716990, ling.yuan@sinotau.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Efficacy of XTR004 PET myocardial perfusion imaging (MPI) for detecting restrictive stenosis, using quantitative coronary angiography (QCA) and fractional flow reserve (FFR) as reference standards (time frame: 60 days). 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 3 Mar 2026.