ST-segment Elevation Myocardial Infarction (STEMI)Phase 2FEND-AMINCT06548204
Effect and Safety of Fexofenadine Hydrochloride vs Placebo in Patients With Acute Myocardial Infaction: A Randomized Clinical Trial
A Phase 2 study testing Fexofenadine Hydrochloride in people with ST-segment Elevation Myocardial Infarction (STEMI), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction (STEMI)
- What is being tested?
- Fexofenadine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2025to 30 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages above 18;
- Being able to verbally confirm understanding of the trial risks, benefits, and treatment options of receiving treatment with fexofenadine hydrochloride. He/she or his/her legal representative shall provide written informed consent before participating in the clinical trial.
- Meet the diagnostic criteria for STEMI, the diagnostic criteria includes:
- Clinical symptoms: ischemic chest pain lasting for over 30 minites;
- Elevated serum cTn: at least once higher than the upper limit of normal values (99th percentile of the reference upper limit);
- ST segment elevation: new ST segment elevation in two or more adjacent leads on the ECG;
- Emergency coronary angiography and revascularization should be performed;
- Ultrasonic cardiogram indicates regional wall motion abnormality, and transthoracic echocardiography shows LVEF ≤ 50% within 72 hours after revascularization.
Who cannot join
- Long term use of fexofenadine hydrochloride or other H1 receptor inhibitors;
- Previously suffered from myocardial infarction or received coronary artery bypass grafting;
- Patients with concomitant cardiomyopathy or valve disease;
- History of severe renal failure, estimated glomerular filtration rate (eGFR) < 30ml/min;
- History of severe liver dysfunction;
- Concurrent severe infections, or liver/gallbladder obstruction, or history of malignant tumors;
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- Currently receiving immunosuppressive therapy;
- Pregnant or potentially pregnant and breastfeeding women;
- Contraindications for fexofenadine hydrochloride or cardiac magnetic resonance examinations;
- Without obtaining written informed consent.
- Patients with hemodynamic instability.
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
The 2nd Affiliated Hopital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310000
Prof. Yinchuan Xu, 86-13968126628, lsyrmxyc@126.com
About this study
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.
Read the detailed description
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).
- Being tested
- Fexofenadine Hydrochloride, Placebo
- 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.
Fexofenadine HydrochlorideDrug
Fexofenadine hydrochloride 60mg bid treatment for 6 months on the basis of standard treatment.
PlaceboOther
Placebo administration for 6 months on the basis of standard treatment.
| Study group | Role | What they receive |
|---|---|---|
| Fexofenadine hydrochloride | Experimental | Fexofenadine hydrochloride 60mg bid was added to the standard treatment 3 days after the completion of primary PCI and CMR examination for 6 months. Receives: Drug: Fexofenadine Hydrochloride |
| Placebo | Placebo comparator | Participants will receive a matched 60mg placebo tablet orally twice a day for 6 months, which was added to the standard treatment. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late gadolinium enhancement/Left ventricular mass (LGE/LV%)
The difference of LGE/LV% from baseline. LGE/LV% will be assessed by CMR.
Measured: 6 months after myocardial infarction
Secondary outcomes (15)
Left ventricular ejection fraction (LVEF)
The difference of LVEF from baseline. LVEF will be assessed by CMR.
Measured: 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.
Measured: 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.
Measured: 6 months after myocardial infarction
Left ventricular ejection fraction (LVEF)
The difference of LVEF from baseline. LVEF will be assessed by UCG.
Measured: 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.
Measured: 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.
Measured: 6 months after myocardial infarction
Extracellular volume (ECV)
The difference of ECV from baseline. ECV will be assessed by CMR.
Measured: 6 months after myocardial infarction
Intramyocardial hemorrhage (IMH)
Analysis of differences of IMH from baseline.
Measured: 6 months after myocardial infarction
stroke volume
Analysis of differences of stroke volume from baseline.
Measured: 6 months after myocardial infarction
peri-infarct zone
Analysis of differences of peri-infarct zone from baseline.
Measured: 6 months after myocardial infarction
BNP
Analysis of differences of BNP from baseline.
Measured: 6 months after myocardial infarction
VO2 max
Analysis of VO2 max.
Measured: 6 months after myocardial infarction
SAQ scale score
Analysis of SAQ scale score.
Measured: 6 months after myocardial infarction
Drug-associated adverse reaction
Heart, nerve system, mental system, digestive system and immune system reactions.
Measured: 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.
Measured: 6 months after myocardial infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start20 Jan 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-segment Elevation Myocardial Infarction (STEMI)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinyang Hu, PhD, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548204
- Sponsor's protocol ID
- YAN2024-0866
- Acronym
- FEND-AMI
- Status last verified
- Jan 2026
- First submitted
- 25 Jul 2024
- Last updated
- 16 Sep 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Safety of Fexofenadine Hydrochloride vs Placebo in Patients With Acute Myocardial Infaction: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06548204
- Acronym / sponsor ID
- FEND-AMI / YAN2024-0866
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 12 Aug 2024 (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 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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fexofenadine hydrochloride | Experimental | Drug: Fexofenadine HydrochlorideFexofenadine hydrochloride 60mg bid was added to the standard treatment 3 days after the completion of primary PCI and CMR examination for 6 months. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive a matched 60mg placebo tablet orally twice a day for 6 months, which was added to the standard treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ages above 18;
- Being able to verbally confirm understanding of the trial risks, benefits, and treatment options of receiving treatment with fexofenadine hydrochloride. He/she or his/her legal representative shall provide written informed consent before participating in the clinical trial.
- Meet the diagnostic criteria for STEMI, the diagnostic criteria includes:
- Emergency coronary angiography and revascularization should be performed;
- Ultrasonic cardiogram indicates regional wall motion abnormality, and transthoracic echocardiography shows LVEF ≤ 50% within 72 hours after revascularization.
Key exclusion criteria (11 listed)
- Long term use of fexofenadine hydrochloride or other H1 receptor inhibitors;
- Previously suffered from myocardial infarction or received coronary artery bypass grafting;
- Patients with concomitant cardiomyopathy or valve disease;
- History of severe renal failure, estimated glomerular filtration rate (eGFR) < 30ml/min;
- History of severe liver dysfunction;
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 |
|---|---|---|
| Fexofenadine HydrochlorideFexofenadine hydrochloride 60mg bid treatment for 6 months on the basis of standard treatment. | Drug | Fexofenadine hydrochloride |
| PlaceboPlacebo administration for 6 months on the basis of standard treatment. | Other | Placebo |
Primary outcome
Late gadolinium enhancement/Left ventricular mass (LGE/LV%)
Time frame: 6 months after myocardial infarction
The difference of LGE/LV% from baseline. LGE/LV% will be assessed by CMR.
15 secondary outcomes
Left ventricular ejection fraction (LVEF)
Time frame: 6 months after myocardial infarction
Left ventricular end-systolic volume/body surface area (LVESV/BSA%)
Time frame: 6 months after myocardial infarction
Left ventricular end-diastolic volume/body surface area (LVEDV/BSA%)
Time frame: 6 months after myocardial infarction
Left ventricular ejection fraction (LVEF)
Time frame: 6 months after myocardial infarction
Left ventricular end-systolic volume/body surface area (LVESV/BSA%)
Time frame: 6 months after myocardial infarction
Left ventricular end-diastolic volume/body surface area (LVEDV/BSA%)
Time frame: 6 months after myocardial infarction
Extracellular volume (ECV)
Time frame: 6 months after myocardial infarction
Intramyocardial hemorrhage (IMH)
Time frame: 6 months after myocardial infarction
stroke volume
Time frame: 6 months after myocardial infarction
peri-infarct zone
Time frame: 6 months after myocardial infarction
BNP
Time frame: 6 months after myocardial infarction
VO2 max
Time frame: 6 months after myocardial infarction
SAQ scale score
Time frame: 6 months after myocardial infarction
Drug-associated adverse reaction
Time frame: 1 month, 3 months and 6 months after myocardial infarction
Incidence of MACE
Time frame: 6 months after myocardial infarction
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 16 Sep 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.
Xinyang Hu, PhD principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fexofenadine Hydrochloride in people with ST-segment Elevation Myocardial Infarction (STEMI), 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 8 inclusion and 11 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 16 Sep 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. 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?
Contact Yinchuan Xu, PhD (86-13968126628, lsyrmxyc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late gadolinium enhancement/Left ventricular mass (LGE/LV%) (time frame: 6 months after myocardial infarction). 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 16 Sep 2026.