A Phase 2 interventional study of Fexofenadine Hydrochloride and Placebo in ST-segment Elevation Myocardial Infarction (STEMI), sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Phase 2, Interventional, and Treatment
Among 146 studies in ST Elevation Myocardial Infarction with a site in China — 42 open to participants now, 44 under way, 2 of them phase 3. ST Elevation Myocardial Infarction · China.
Among the 146 studies in ST Elevation Myocardial Infarction with a site in China, this one is the 74th largest by planned enrollment of the 97 interventional ones, is one of 11 that started in 2025, is one of 6 in phase 2, reaches primary completion later than 13 of the 42 other live ones, and was the 116th registered.
850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.
This study's planned enrollment of 160 is below the median of 194 across 527 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →42 of the 146 studies in ST Elevation Myocardial Infarction with a site in China are open now, in 12 countries. Each count lists the studies.
Of the 122 ST Elevation Myocardial Infarction studies recruiting now, 76 (62%) set no upper age limit and 20 (16%) stop at 75 or younger; 10 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →146 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 11 started in 2025.
Median enrollment 320 across the 97 interventional studies, 737 across the 48 observational. Of the 39 that completed or were terminated, 1 (3%) have results posted.
12 of 146 have an industry lead sponsor. The 10 most frequent:
Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 99 studies on the registry; 67 are open to participants now.
Second Affiliated Hospital, Zhejiang University, School of Medicine has 2 studies filed under ST Elevation Myocardial Infarction — fewer than ten, so there is no comparison to draw.
17 of the studies in ST Elevation Myocardial Infarction with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07102628Phase 3Novartis PharmaceuticalsEvaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes | 2027-02-11 |
| NCT06794801LanZhou UniversityEvaluating the Safety and Efficacy of Drug-Coated Autoperfusion Balloons Versus Conventional Drug-Coated Balloons Guided by IVUS-OCT Multimodal Imaging for Treating Acute Myocardial Infarction: OPERA-AMI Study | 2026-12 |
| NCT05967663RenJi HospitalFractional Flow Reserve Guided Immediate Versus Staged Complete Myocardial Revascularization in Patients With ST-segment Elevation Myocardial Infarction With Multivessel Disease (Future Study) | 2026-12 |
| NCT06339021Shenyang Northern HospitalOCT or Angiography Guided De-escalation of DAPT | 2026-12-01 |
| NCT06548204Second Affiliated Hospital, Zhejiang University, School of MedicineEffect and Safety of Fexofenadine Hydrochloride vs Placebo in Patients With Acute Myocardial Infaction: A Randomized Clinical Trial | 2026-12-30 |
Among the 146 studies in ST Elevation Myocardial Infarction with a site in China, from their registry updates:
The purpose of this study was to evaluate the efficacy and safety of fexofenadine hydrochloride on the basis of standard treatment after PCI in STEMI patients.
Background: Cardiac fibrosis caused by acute myocardial infarction is one of the major causes of death for cardiovascular disease patients in China. Previous research found that expression of FMO2 in heart significantly decreased after myocardial infarction. Overexpression of FMO2 in cardiac fibroblasts using lentivirus can reduce collagen deposition and improve cardiac function, which suggest that FMO2 can be a target for treating cardiac fibrosis. The investigators used the FDA drug library to screen drugs that promote FMO2 expression, then validated the top ranked candidate drug and found that fexofenadine hydrochloride had the most significant effect. Animal experiments found that fexofenadine significantly improved the heart function and reduced heart fibrosis in mice after myocardial infarction and has no significant side effects on liver or kidney function. Fexofenadine Hydrochloride is a third-generation H1 receptor antagonist mainly used to treat allergic diseases such as seasonal allergic rhinitis and chronic idiopathic urticarial. However, currently no study evaluates the efficacy and safety of fexofenadine hydrochloride in treating acute myocardial infarction in human.
Purpose: The purpose of this study was to evaluate the efficacy and safety of fexofenadine hydrochloride on the basis of standard treatment after PCI in STEMI patients.
Study design: This study is a prospective, multi-center, double blind, randomized controlled clinical trial. The study objects are STEMI patients: left ventricular ejection fraction (LVEF)≤50%, and primary PCI was performed. Participants will be randomly assigned to control group and fexofenadine group in a 1:1 ratio. The control group will receive placebo 3 days after primary PCI for 6 months based on the standard treatment. The fexofenadine group will receive fexofenadine hydrochloride 60mg bid 3 days after primary PCI for 6 months on the basis of standard treatment, and both groups will be followed up for 6 months.
Outcome measure: The primary outcome is late gadolinium enhancement/left ventricular mass (LGE/LV mass%). The secondary outcomes are left ventricular ejection fraction (LVEF%), left ventricular end-systolic volume/body surface area (LVESV/BSA%), left ventricular end-diastolic volume/body surface area (LVEDV/BSA%), extracellular volume (ECV), intramyocardial hemorrhage (IMH), stroke volume, peri-infarct zone, BNP, VO2 max, SAQ scale score, drug-associated adverse events and incidence of MACE (including cardiac death, myocardial infarction, readmission due to heart failure).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Meet the diagnostic criteria for STEMI, the diagnostic criteria includes:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fexofenadine hydrochloride 60mg bid was added to the standard treatment 3 days after the completion of primary PCI and CMR examination for 6 months.
Drug: Fexofenadine Hydrochloride
Participants will receive a matched 60mg placebo tablet orally twice a day for 6 months, which was added to the standard treatment.
Other: Placebo
Fexofenadine hydrochloride 60mg bid treatment for 6 months on the basis of standard treatment.
Placebo administration for 6 months on the basis of standard treatment.
Late gadolinium enhancement/Left ventricular mass (LGE/LV%)
The difference of LGE/LV% from baseline. LGE/LV% will be assessed by CMR.
Time frame: 6 months after myocardial infarction
Left ventricular ejection fraction (LVEF)
The difference of LVEF from baseline. LVEF will be assessed by CMR.
Time frame: 6 months after myocardial infarction
Left ventricular end-systolic volume/body surface area (LVESV/BSA%)
The difference of LVESV/BSA% from baseline. LVESV will be assessed by CMR and BSA will be calculated by height and weight.
Time frame: 6 months after myocardial infarction
Left ventricular end-diastolic volume/body surface area (LVEDV/BSA%)
The difference of LVEDV/BSA% from baseline. LVEDV will be assessed by CMR and BSA will be calculated by height and weight.
Time frame: 6 months after myocardial infarction
Left ventricular ejection fraction (LVEF)
The difference of LVEF from baseline. LVEF will be assessed by UCG.
Time frame: 6 months after myocardial infarction
Left ventricular end-systolic volume/body surface area (LVESV/BSA%)
The difference of LVESV/BSA% from baseline. LVESV will be assessed by UCG and BSA will be calculated by height and weight.
Time frame: 6 months after myocardial infarction
Left ventricular end-diastolic volume/body surface area (LVEDV/BSA%)
The difference of LVEDV/BSA% from baseline. LVEDV will be assessed by UCG and BSA will be calculated by height and weight.
Time frame: 6 months after myocardial infarction
Extracellular volume (ECV)
The difference of ECV from baseline. ECV will be assessed by CMR.
Time frame: 6 months after myocardial infarction
Intramyocardial hemorrhage (IMH)
Analysis of differences of IMH from baseline.
Time frame: 6 months after myocardial infarction
stroke volume
Analysis of differences of stroke volume from baseline.
Time frame: 6 months after myocardial infarction
peri-infarct zone
Analysis of differences of peri-infarct zone from baseline.
Time frame: 6 months after myocardial infarction
BNP
Analysis of differences of BNP from baseline.
Time frame: 6 months after myocardial infarction
VO2 max
Analysis of VO2 max.
Time frame: 6 months after myocardial infarction
SAQ scale score
Analysis of SAQ scale score.
Time frame: 6 months after myocardial infarction
Drug-associated adverse reaction
Heart, nerve system, mental system, digestive system and immune system reactions.
Time frame: 1 month, 3 months and 6 months after myocardial infarction
Incidence of MACE
Incidence of Cardiac death, myocardial infarction and readmission due to heart failure.
Time frame: 6 months after myocardial infarction
Plan to share: No
Started Jan 2025 (actual). Primary completion is estimated for Dec 2026, 23 months after the start.
Of 31 phase 2 interventional studies under ST Elevation Myocardial Infarction, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 39. This study's planned 23 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Fexofenadine
ST Elevation Myocardial Infarction →
Second Affiliated Hospital, Zhejiang University, School of Medicine