Effect and Safety of Fexofenadine Hydrochloride vs Placebo in Patients With Acute Myocardial Infaction: A Randomized Clinical Trial

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fexofenadine Hydrochloride

    Drug

    Fexofenadine hydrochloride 60mg bid treatment for 6 months on the basis of standard treatment.

  • Placebo

    Other intervention

    Placebo administration for 6 months on the basis of standard treatment.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Fexofenadine hydrochlorideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Left ventricular ejection fraction (LVEF)

The difference of LVEF from baseline. LVEF will be assessed by CMR.

Time frame
6 months after myocardial infarction
2

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
3

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
4

Left ventricular ejection fraction (LVEF)

The difference of LVEF from baseline. LVEF will be assessed by UCG.

Time frame
6 months after myocardial infarction

Other outcomes

Sponsors and contacts

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