Zhejiang UniversityPhase 3NCT07381803
The Impact of Fexofenadine Hydrochloride on the Prognosis of Patients Post-Acute Myocardial Infarction
A Phase 3 study testing Fexofenadine 60 Mg Oral Tablet in people with Zhejiang University, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this study is o evaluate the prognostic effect of fexofenadine hydrochloride in patients with myocardial infarction Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Zhejiang University
- What is being tested?
- Fexofenadine 60 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,804 participants
- Where
- 1 siteChina
- Study dates
- 27 Jan 2025to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Able to verbally confirm understanding of the trial risks, benefits, and treatment options of fexofenadine hydrochloride therapy. He/she or his/her legal representative must provide written informed consent prior to participating in the clinical trial.
- Acute ST-segment elevation myocardial infarction (STEMI) occurring within 7 days, with diagnostic criteria including:
- Typical clinical symptoms: such as severe crushing pain in the retrosternal or precordial area, usually lasting more than 10-20 minutes, which may radiate to the left upper arm, jaw, neck, back, or shoulders, etc.; ii) Elevated serum cardiac troponin (cTn): at least one measurement above the upper limit of normal (99th percentile of the reference upper limit); iii) ST-segment elevation: new ST-segment elevation at the J point in 2 adjacent leads.
- Echocardiography indicating segmental wall motion abnormalities.
Who cannot join
- Need for long-term use of fexofenadine hydrochloride or other H1 receptor inhibitors.
- Previous coronary artery bypass grafting (CABG) surgery.
- History of severe renal failure with estimated glomerular filtration rate (eGFR) < 30 ml/min.
- History of severe liver dysfunction.
- History of concurrent severe infection, hepatobiliary obstruction, or malignant tumor.
- Expected life expectancy of less than 2 years due to non-cardiac diseases.
Show all 11Show fewer
- Currently receiving immunosuppressive therapy.
- Pregnant, potentially pregnant, or lactating women.
- Contraindication to the study drug or examinations.
- Failure to provide written informed consent.
- Presence of mechanical complications (ventricular septal defect, papillary muscle dysfunction, acute mitral regurgitation), refractory cardiogenic shock unresponsive to vasopressors, acute left heart failure or pulmonary edema, or malignant arrhythmias uncontrolled by antiarrhythmic drugs at enrollment.
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 Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310000
Xinyang Hu, +86 13856166372, hxy0507@zju.edu.cn
About this study
Official title: The Impact of Fexofenadine Hydrochloride on the Prognosis of Patients Post-Acute Myocardial Infarction: A Randomized Clinical Trial (FEND Ⅱ)
The goal of this study is o evaluate the prognostic effect of fexofenadine hydrochloride in patients with myocardial infarction
- Conditions
- Zhejiang University
- Being tested
- Fexofenadine 60 Mg Oral Tablet, Placebo
- Keywords
- myocardial infarction, cardiac fibrosis, cardiac MRI
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fexofenadine 60 Mg Oral TabletDrug
Fexofenadine, 60mg BID oral
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Fexofenadine | Experimental | 60mg, BID Receives: Drug: Fexofenadine 60 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular and cerebrovascular events (MACCE)
MACCE within 24 months after randomization, including all-cause death, recurrent myocardial infarction, stroke, hospitalization for heart failure, outpatient or emergency visits due to worsening heart failure, and repeat revascularization driven by angina pectoris.
Measured: 24 months
Secondary outcomes (8)
All-cause death
All-cause death between 2 groups
Measured: 24 months, 60 months after myocardial infarction
Recurrent myocardial infarction
Recurrent myocardial infarction between 2 groups
Measured: 24 and 60 months after myocardial infarction
Stroke
Stroke incidence between 2 groups
Measured: 24 and 60 months after myocardial infarction
Hospitalization for heart failure
The incidence of Hospitalization for heart failure between 2 groups
Measured: 24 and 60 months after myocardial infarction
Repeat revascularization driven by angina pectoris
Repeat revascularization driven by angina pectoris between 2 groups
Measured: 24 and 60 months after myocardial infarction
Left ventricular ejection fraction (LVEF%)
Comparison of the difference in left ventricular ejection fraction (LVEF%) measured by echocardiography between the two groups at 24 months after randomization compared to baseline.
Measured: 24 months after myocardial infarction
Left ventricular end-systolic diameter (LVIDs)
Comparison of the difference in left ventricular end-systolic diameter (LVIDs) measured by echocardiography between the two groups at 24 months after randomization compared to baseline.
Measured: 24 months after myocardial infarction
Left ventricular end-diastolic diameter (LVIDd)
Comparison of the difference in left ventricular end-diastolic diameter (LVIDd) measured by echocardiography between the two groups at 24 months after randomization compared to baseline.
Measured: 24 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 posted2 Feb 2026
- Study start27 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zhejiang UniversityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,804 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381803
- Sponsor's protocol ID
- YAN2025-1734
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Fexofenadine Hydrochloride on the Prognosis of Patients Post-Acute Myocardial Infarction: A Randomized Clinical Trial (FEND Ⅱ)
- ClinicalTrials.gov ID
- NCT07381803
- Acronym / sponsor ID
- YAN2025-1734
- Conditions
- Zhejiang University
- Keywords
- myocardial infarction, cardiac fibrosis, cardiac MRI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,804 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 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 goal of this study is o evaluate the prognostic effect of fexofenadine hydrochloride in patients with myocardial infarction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebo |
| Fexofenadine | Experimental | Drug: Fexofenadine 60 Mg Oral Tablet60mg, BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old.
- Able to verbally confirm understanding of the trial risks, benefits, and treatment options of fexofenadine hydrochloride therapy. He/she or his/her legal representative must provide written informed consent prior to participating in the clinical trial.
- Acute ST-segment elevation myocardial infarction (STEMI) occurring within 7 days, with diagnostic criteria including:
- Echocardiography indicating segmental wall motion abnormalities.
Key exclusion criteria (11 listed)
- Need for long-term use of fexofenadine hydrochloride or other H1 receptor inhibitors.
- Previous coronary artery bypass grafting (CABG) surgery.
- History of severe renal failure with estimated glomerular filtration rate (eGFR) < 30 ml/min.
- History of severe liver dysfunction.
- History of concurrent severe infection, hepatobiliary obstruction, or malignant tumor.
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 60 Mg Oral TabletFexofenadine, 60mg BID oral | Drug | Fexofenadine |
| Placeboplacebo | Drug | placebo |
Primary outcome
Major adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: 24 months
MACCE within 24 months after randomization, including all-cause death, recurrent myocardial infarction, stroke, hospitalization for heart failure, outpatient or emergency visits due to worsening heart failure, and repeat revascularization driven by angina pectoris.
8 secondary outcomes
All-cause death
Time frame: 24 months, 60 months after myocardial infarction
Recurrent myocardial infarction
Time frame: 24 and 60 months after myocardial infarction
Stroke
Time frame: 24 and 60 months after myocardial infarction
Hospitalization for heart failure
Time frame: 24 and 60 months after myocardial infarction
Repeat revascularization driven by angina pectoris
Time frame: 24 and 60 months after myocardial infarction
Left ventricular ejection fraction (LVEF%)
Time frame: 24 months after myocardial infarction
Left ventricular end-systolic diameter (LVIDs)
Time frame: 24 months after myocardial infarction
Left ventricular end-diastolic diameter (LVIDd)
Time frame: 24 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 7 Aug 2026.
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Outcome
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fexofenadine 60 Mg Oral Tablet in people with Zhejiang University, 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 5 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 7 Aug 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 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 Cheng Ni (+8615088555539, cescni@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 cardiovascular and cerebrovascular events (MACCE) (time frame: 24 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 7 Aug 2026.