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

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

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;

History of severe renal failure, estimated glomerular filtration rate (eGFR) < 30ml/min;

History of severe liver dysfunction, total bilirubin (TBil) > the upper limit of normal, or AST/ALT > 3 times the upper limit of normal, or alkaline phosphatase > 2.5 times the upper limit of normal;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fexofenadine Hydrochloride 60mg bid

    Drug

    Fexofenadine hydrochloride 60mg bid treatment for 6 months.

  • Placebo

    Other intervention

    Placebo administration for 6 months.

  • Fexofenadine Hydrochloride 120mg bid

    Drug

    Fexofenadine hydrochloride 120mg bid treatment for 6 months.

Treatment groups

165 Participants
are divided into 3 treatment groups
Group A: Fexofenadine hydrochloride 60mg bidExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Fexofenadine hydrochloride 120mg bidExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Late gadolinium enhancement/Left ventricular mass (LGE/LV%)

LGE/LV% will be assessed by CMR

Time frame
6 months after myocardial infarction

Secondary outcomes

1

Left ventricular ejection fraction (LVEF)

LVEF will be assessed by CMR

Time frame
6 months after myocardial infarction
2

Left ventricular internal dimension in systole/body surface area (LVIDs/BSA%)

LVIDs will be assessed by CMR and BSA will be calculated by height and weight

Time frame
6 months after myocardial infarction
3

Left ventricular internal dimension in diastole/body surface area (LVIDd/BSA%)

LVIDd will be assessed by CMR and BSA will be calculated by height and weight

Time frame
6 months after myocardial infarction
4

BNP

Analysis of differences of BNP

Time frame
6 months after myocardial infarction

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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