STEMI (ST Elevation MI)Phase 2NCT07621107
Effect of Guanxinning Tablet on Coronary Microcirculation After Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction
A Phase 2 study testing Guanxinning Tablet(GXNT) in people with STEMI (ST Elevation MI) and STEMI - ST Elevation Myocardial Infarction, run by Beijing Anzhen Hospital.
Trial summary
①Research objective: In a small sample population, through the pre - experimental method, explore and evaluate the effect of Guanxinning tablets on the coronary microcirculation after primary percutaneous coronary intervention (PPCI) in patients with acute ST - segment elevation myocardial infarction (STEMI), with the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- STEMI (ST Elevation MI), STEMI - ST Elevation Myocardial Infarction, STEMI
- What is being tested?
- Guanxinning Tablet(GXNT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Feb 2027
- Phase
- Phase 2
- 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
- Age between 18 and 80 years (gender is not restricted).
- STEMI diagnosed for the first time and with an onset time within 12 hours. (According to the "Chinese Guidelines for the Diagnosis and Treatment of Acute ST - Segment Elevation Myocardial Infarction 2019" and the fourth - edition "Global Definition of Myocardial Infarction" criteria, myocardial infarction refers to acute myocardial injury [serum cardiac troponin (cTn) increases and/or decreases, and at least once is higher than the upper limit of the normal value (the 99th percentile of the upper limit of the reference value)], along with clinical evidence of acute myocardial ischemia, including: (1) Symptoms of acute myocardial ischemia; (2) New ischemic electrocardiogram changes; (3) New pathological Q - wave; (4) New imaging evidence of viable myocardial loss or abnormal wall segmental motion; (5) Coronary artery thrombosis confirmed by coronary angiography, intracavitary imaging examination, or autopsy.)
- Successfully received PPCI treatment (assessed by visual inspection or quantitative coronary angiography, with residual stenosis of the target lesion < 20% after stent implantation or < 50% after simple balloon dilation, and forward TIMI blood flow ≥ grade 2).
- Signed a written informed consent form.
Who cannot join
- Cardiogenic shock with poor response to vasoactive drugs; or uncontrolled acute left - heart failure or pulmonary edema; uncontrolled malignant arrhythmia.
- LVEF < 40%.
- Currently using nicorandil, other Chinese patent medicines, and Chinese herbal decoctions, etc.
- Unable to undergo CMR examination for various reasons.
- Expected to be unable to complete 6 - month treatment with Guanxinning Tablets.
- Contraindications or allergies to Guanxinning Tablets.
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- Suspected or confirmed hereditary cardiomyopathy (such as hypertrophic, dilated, obstructive cardiomyopathy, cardiac amyloidosis, hemochromatosis cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, etc.).
- Active or chronic liver disease.
- Renal insufficiency (eGFR < 60ml/min/1.73m²).
- History of previous cerebral hemorrhage.
- History of alcohol or drug abuse.
- Known active infection, or severe hematological, metabolic, or endocrine dysfunction.
- Patients who have received systemic steroid or cyclosporine treatment in the past 3 months.
- Active malignant tumor.
- Life expectancy less than 6 months.
- Pregnant or lactating women.
- Already participating in other clinical studies.
About this study
Official title: A Randomized Explorative Pre-trial of the Effect of Guanxinning Tablet on Coronary Microcirculation After Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction
①Research objective: In a small sample population, through the pre - experimental method, explore and evaluate the effect of Guanxinning tablets on the coronary microcirculation after primary percutaneous coronary intervention (PPCI) in patients with acute ST - segment elevation myocardial infarction (STEMI), with the change in the percentage of intramyocardial hemorrhage (IMH) in ventricular mass measured by cardiac magnetic resonance (CMR) imaging as the primary endpoint.
②Research significance: The research results of this project will provide preliminary theoretical basis and methodological support for the formal randomized controlled study on evaluating the effect of Guanxinning tablets on the coronary microcirculation after PPCI in STEMI patients. It will offer new ideas for the long - term clinical treatment of STEMI patients after PPCI, and provide important theoretical support for expanding the clinical indications of Guanxinning tablets and exploring the reasons for its improvement of cardiovascular outcomes.
Read the detailed description
This study is a preliminary pre-trial for a single-center, prospective, randomized, double-blind, placebo-controlled trial. The objective is to explore the effect of Guanxinning Tablet on improving coronary microcirculation. A total of 70 STEMI patients who have successfully undergone primary percutaneous coronary intervention (PPCI) will be enrolled. Regardless of whether elective complete revascularization is needed, after the IRA (infarct-related artery) is treated during PPCI, patients will be randomly assigned in a 1:1 ratio to two groups: one group will receive an immediate loading dose of 4 Guanxinning Tablets post-PPCI, followed by a maintenance dose of 4 tablets three times daily (TID) (intervention group), while the other group will receive placebo treatment (placebo group). Both groups will receive standard secondary prevention treatment for coronary heart disease. Patients in both groups will undergo cardiac magnetic resonance (CMR) examinations within 1 week after PPCI and at 6 months (±14 days) post-PPCI.
Primary Endpoint:
The change in the percentage of intramyocardial hemorrhage (IMH) volume relative to ventricular volume in the IRA-supplied myocardial territory, measured by CMR at the 6-month follow-up.
Secondary Endpoints:
- Change in the incidence of IMH in the IRA-supplied myocardial territory measured by CMR at 6 months.
- Change in the percentage of microvascular obstruction (MVO) volume in the IRA-supplied myocardial territory measured by CMR at 6 months.
- Change in the incidence of MVO in the IRA-supplied myocardial territory measured by CMR at 6 months.
- Change in myocardial infarct size and percentage of myocardial edema volume measured by CMR at 6 months.
- Change in left ventricular ejection fraction (LVEF) measured by echocardiography at 6 months.
- Change in angina pectoris score at 6 months. ⑦ Change in traditional Chinese medicine (TCM) syndrome score for blood stasis pattern at 6 months.
- Association between changes in circulating inflammatory markers (oxidized LDL, IL-6, hsCRP) and diabetes markers (HbA1c, FBG, GSP) at 6 months with coronary microcirculation status.
Safety Endpoints:
Composite endpoint including all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, ischemia-driven repeat revascularization, rehospitalization for heart failure, and any drug-related adverse reactions.
- Conditions
- STEMI (ST Elevation MI), STEMI - ST Elevation Myocardial Infarction, STEMI, CMD, Coronary Microvascular Dysfunction (CMD)
- Being tested
- Guanxinning Tablet(GXNT), Placebo
- Keywords
- TCM, traditional chinese medicine, guanxinning tablet, CMR, intramyocardial hemorrhage
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guanxinning Tablet(GXNT)Drug
Guanxinning Tablets (2015), an established treatment for stable exertional angina (Grades I-II) with TCM-diagnosed heart-blood stasis syndrome, demonstrates proven safety/efficacy. Its active components (e.g., tanshinone IIA, salvianolic acid B, tetramethylpyrazine) from Salvia miltiorrhiza and Ligusticum chuanxiong exert:
Anti-atherosclerotic effects via:
Anti-inflammation \& anti-LDL oxidation Endothelial improvement VSMC proliferation/migration inhibition Anti-platelet aggregation
Microvascular protection through:
Anti-apoptosis \& autophagy regulation Platelet adhesion inhibition Reduced inflammatory factor release
PlaceboDrug
In this study, the placebo used in the placebo control group was completely consistent with the Guanxinning Tablets (GXNT) used in the experimental group in terms of appearance, including color, shape, size, gloss, odor, bitterness, dissolution rate, and packaging.
| Study group | Role | What they receive |
|---|---|---|
| GXNT treatment group | Experimental | Immediately after PPCI, the patient was given a loading dose of 4 tablets of Guanxinning Tablets, and then 4 tablets of Guanxinning Tablets were given tid for maintenance treatment, along with standard secondary prevention treatment for coronary heart disease. Receives: Drug: Guanxinning Tablet(GXNT) |
| standard treatment group | Placebo comparator | Immediately after PPCI, the patient was given a loading dose of 4 tablets of placebo, and then 4 tablets of placebo were given tid for maintenance treatment, along with standard secondary prevention treatment for coronary heart disease. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
△IMH volume (%)
The change in the percentage of intramyocardial hemorrhage (IMH) volume relative to ventricular volume in the IRA-supplied myocardial territory, measured by CMR at the 6-month follow-up.
Measured: 6 months
Secondary outcomes (14)
incidence of IMH (%)
Change in the incidence of IMH in the IRA-supplied myocardial territory measured by CMR at 6 months.
Measured: 6 months
△MVO volume (%)
Change in the percentage of microvascular obstruction (MVO) volume in the IRA-supplied myocardial territory measured by CMR at 6 months.
Measured: 6 months
incidence of MVO (%)
Change in the incidence of MVO in the IRA-supplied myocardial territory measured by CMR at 6 months.
Measured: 6 months
myocardial infarct size (/ventricular volume, %)
Change in myocardial infarct size (/ventricular volume,%) measured by CMR at 6 months.
Measured: 6 months
myocardial edema volume (/ventricular volume, %)
Change in percentage of myocardial edema volume (/ventricular volume, %) measured by CMR at 6 months.
Measured: 6 months
△LVEF (%)
Change in left ventricular ejection fraction (LVEF) measured by echocardiography at 6 months.
Measured: 6 months
CCS Angina Classification change
Change in Canada Cardiovascular Society Angina Classification score at 6 months.
Class I: Ordinary physical activity, such as walking and climbing stairs, does not cause angina. Angina occurs with strenuous, rapid, or prolonged exertion at work or recreation.
Class II: Slight limitation of ordinary activity. Angina occurs on walking or climbing stairs rapidly, walking uphill, walking or stair - climbing after meals, in cold, in wind, or under emotional stress. Angina occurs on walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace.
Class III: Marked limitation of ordinary physical activity. Angina occurs on walking one to two blocks on the level and climbing one flight of stairs at a normal pace.
Class IV: Inability to carry on any physical activity without discomfort. Angina may be present at rest.
The lowest CCS angina pectoris score is grade I, and the highest is grade IV. The higher the grade, the worse the outcome.
Measured: 6 months
TCM blood stasis pattern score change
Change in traditional Chinese medicine (TCM) syndrome score for blood stasis pattern at 6 months.
- Main Index: Fixed location of chest pain(10 score); Purple or dark - colored tongue(10); Ecchymosis and petechiae on the tongue(10); oronary angiography shows that at least one coronary artery is stenosed ≥ 75%(9); Ultrasound or angiography shows coronary artery thrombosis or intracardiac mural thrombosis(8); ②Secondary Index: Chest pain worsens at night(6); Purple - dark lips or gums(7); Varicose sublingual veins or purple - dark color(7); CAG shows that at least one coronary artery is stenosed ≥ 50% but < 75%(6); Shortening of APTT or PT(5); ③Auxiliary Index: Dark - black complexion(2); Stringy pulse(4); CCTA or CAG shows obvious vascular calcification or diffuse lesions(3); Elevated fibrinogen (3); The maximum value is 80, the minimum is not clearly defined as it depends on the combination of positive indexes; The higher the score, the more severe the symptom as well as the outcome.
Measured: 6 months
circulating inflammatory markers absolute change(oxidized LDL, mmol/L)
absolute changes in circulating inflammatory markers: oxidized LDL(mmol/L) at 6 months
Measured: 6 months
circulating inflammatory markers absolute change (IL-6, pg/mL)
absolute changes in circulating inflammatory markers: IL-6(pg/mL) at 6 months
Measured: 6 months
circulating inflammatory markers absolute change (hsCRP, mg/L)
absolute changes in circulating inflammatory markers hsCRP(mg/L) at 6 months
Measured: 6 months
diabetes markers absolute change (HbA1c, %)
absolute changes in diabetes markers: HbA1c(%) at 6 months
Measured: 6 months
diabetes markers absolute change (FBG, fasting blood glucose, mmol/L)
absolute changes in diabetes markers: FBG, fasting blood glucose, (mmol/L) at 6 months
Measured: 6 months
diabetes markers absolute change of GSP, Glycated serum protein (%)
absolute changes in diabetes markers: GSP, Glycated serum protein (%) at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMI (ST Elevation MI)Studies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621107
- Sponsor's protocol ID
- GXN-CIRC
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Explorative Pre-trial of the Effect of Guanxinning Tablet on Coronary Microcirculation After Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07621107
- Acronym / sponsor ID
- GXN-CIRC
- Conditions
- STEMI (ST Elevation MI), STEMI - ST Elevation Myocardial Infarction, STEMI, CMD, Coronary Microvascular Dysfunction (CMD)
- Keywords
- TCM, traditional chinese medicine, guanxinning tablet, CMR, intramyocardial hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 2 Jun 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.
①Research objective: In a small sample population, through the pre - experimental method, explore and evaluate the effect of Guanxinning tablets on the coronary microcirculation after primary percutaneous coronary intervention (PPCI) in patients with acute ST - segment elevation myocardial infarction (STEMI), with the change in the percentage of intramyocardial hemorrhage (IMH) in ventricular mass measured by cardiac magnetic resonance (CMR) imaging as the primary endpoint.
②Research significance: The research results of this project will provide preliminary theoretical basis and methodological support for the formal randomized controlled study on evaluating the effect of Guanxinning tablets on the coronary microcirculation after PPCI in STEMI patients. It will offer new ideas for the long - term clinical treatment of STEMI patients after PPCI, and provide important theoretical support for expanding the clinical indications of Guanxinning tablets and exploring the reasons for its improvement of cardiovascular outcomes.
Detailed description
This study is a preliminary pre-trial for a single-center, prospective, randomized, double-blind, placebo-controlled trial. The objective is to explore the effect of Guanxinning Tablet on improving coronary microcirculation. A total of 70 STEMI patients who have successfully undergone primary percutaneous coronary intervention (PPCI) will be enrolled. Regardless of whether elective complete revascularization is needed, after the IRA (infarct-related artery) is treated during PPCI, patients will be randomly assigned in a 1:1 ratio to two groups: one group will receive an immediate loading dose of 4 Guanxinning Tablets post-PPCI, followed by a maintenance dose of 4 tablets three times daily (TID) (intervention group), while the other group will receive placebo treatment (placebo group). Both groups will receive standard secondary prevention treatment for coronary heart disease. Patients in both groups will undergo cardiac magnetic resonance (CMR) examinations within 1 week after PPCI and at 6 months (±14 days) post-PPCI.
Primary Endpoint:
The change in the percentage of intramyocardial hemorrhage (IMH) volume relative to ventricular volume in the IRA-supplied myocardial territory, measured by CMR at the 6-month follow-up.
Secondary Endpoints:
- Change in the incidence of IMH in the IRA-supplied myocardial territory measured by CMR at 6 months.
- Change in the percentage of microvascular obstruction (MVO) volume in the IRA-supplied myocardial territory measured by CMR at 6 months.
- Change in the incidence of MVO in the IRA-supplied myocardial territory measured by CMR at 6 months.
- Change in myocardial infarct size and percentage of myocardial edema volume measured by CMR at 6 months.
- Change in left ventricular ejection fraction (LVEF) measured by echocardiography at 6 months.
- Change in angina pectoris score at 6 months. ⑦ Change in traditional Chinese medicine (TCM) syndrome score for blood stasis pattern at 6 months.
- Association between changes in circulating inflammatory markers (oxidized LDL, IL-6, hsCRP) and diabetes markers (HbA1c, FBG, GSP) at 6 months with coronary microcirculation status.
Safety Endpoints:
Composite endpoint including all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, ischemia-driven repeat revascularization, rehospitalization for heart failure, and any drug-related adverse reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GXNT treatment group | Experimental | Drug: Guanxinning Tablet(GXNT)Immediately after PPCI, the patient was given a loading dose of 4 tablets of Guanxinning Tablets, and then 4 tablets of Guanxinning Tablets were given tid for maintenance treatment, along with standard secondary prevention treatment for coronary heart disease. |
| standard treatment group | Placebo comparator | Drug: PlaceboImmediately after PPCI, the patient was given a loading dose of 4 tablets of placebo, and then 4 tablets of placebo were given tid for maintenance treatment, along with standard secondary prevention treatment for coronary heart disease. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 80 years (gender is not restricted).
- STEMI diagnosed for the first time and with an onset time within 12 hours. (According to the "Chinese Guidelines for the Diagnosis and Treatment of Acute ST - Segment Elevation Myocardial Infarction 2019" and the fourth - edition "Global Definition of Myocardial Infarction" criteria, myocardial infarction refers to acute myocardial injury [serum cardiac troponin (cTn) increases and/or decreases, and at least once is higher than the upper limit of the normal value (the 99th percentile of the upper limit of the reference value)], along with clinical evidence of acute myocardial ischemia, including: (1) Symptoms of acute myocardial ischemia; (2) New ischemic electrocardiogram changes; (3) New pathological Q - wave; (4) New imaging evidence of viable myocardial loss or abnormal wall segmental motion; (5) Coronary artery thrombosis confirmed by coronary angiography, intracavitary imaging examination, or autopsy.)
- Successfully received PPCI treatment (assessed by visual inspection or quantitative coronary angiography, with residual stenosis of the target lesion < 20% after stent implantation or < 50% after simple balloon dilation, and forward TIMI blood flow ≥ grade 2).
- Signed a written informed consent form.
Key exclusion criteria (17 listed)
- Cardiogenic shock with poor response to vasoactive drugs; or uncontrolled acute left - heart failure or pulmonary edema; uncontrolled malignant arrhythmia.
- LVEF < 40%.
- Currently using nicorandil, other Chinese patent medicines, and Chinese herbal decoctions, etc.
- Unable to undergo CMR examination for various reasons.
- Expected to be unable to complete 6 - month treatment with Guanxinning Tablets.
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 |
|---|---|---|
| Guanxinning Tablet(GXNT)Guanxinning Tablets (2015), an established treatment for stable exertional angina (Grades I-II) with TCM-diagnosed heart-blood stasis syndrome, demonstrates proven safety/efficacy. Its active components (e.g., tanshinone IIA, salvianolic acid B, tetramethylpyrazine) from Salvia miltiorrhiza and Ligusticum chuanxiong exert: Anti-atherosclerotic effects via: Anti-inflammation \& anti-LDL oxidation Endothelial improvement VSMC proliferation/migration inhibition Anti-platelet aggregation Microvascular protection through: Anti-apoptosis \& autophagy regulation Platelet adhesion inhibition Reduced inflammatory factor release | Drug | GXNT treatment group |
| PlaceboIn this study, the placebo used in the placebo control group was completely consistent with the Guanxinning Tablets (GXNT) used in the experimental group in terms of appearance, including color, shape, size, gloss, odor, bitterness, dissolution rate, and packaging. | Drug | standard treatment group |
Primary outcome
△IMH volume (%)
Time frame: 6 months
The change in the percentage of intramyocardial hemorrhage (IMH) volume relative to ventricular volume in the IRA-supplied myocardial territory, measured by CMR at the 6-month follow-up.
14 secondary outcomes
incidence of IMH (%)
Time frame: 6 months
△MVO volume (%)
Time frame: 6 months
incidence of MVO (%)
Time frame: 6 months
myocardial infarct size (/ventricular volume, %)
Time frame: 6 months
myocardial edema volume (/ventricular volume, %)
Time frame: 6 months
△LVEF (%)
Time frame: 6 months
CCS Angina Classification change
Time frame: 6 months
TCM blood stasis pattern score change
Time frame: 6 months
circulating inflammatory markers absolute change(oxidized LDL, mmol/L)
Time frame: 6 months
circulating inflammatory markers absolute change (IL-6, pg/mL)
Time frame: 6 months
circulating inflammatory markers absolute change (hsCRP, mg/L)
Time frame: 6 months
diabetes markers absolute change (HbA1c, %)
Time frame: 6 months
diabetes markers absolute change (FBG, fasting blood glucose, mmol/L)
Time frame: 6 months
diabetes markers absolute change of GSP, Glycated serum protein (%)
Time frame: 6 months
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 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Guanxinning Tablet(GXNT) in people with STEMI (ST Elevation MI) and STEMI - ST Elevation Myocardial Infarction, run by Beijing Anzhen Hospital.
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 4 inclusion and 17 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: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
△IMH volume (%) (time frame: 6 months). 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 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.