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

NCT06548204 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: YAN2024-0866
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

ST-segment Elevation Myocardial Infarction (STEMI)

Outcome Measures

Primary Outcomes (1)

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

  LGE/LV% will be assessed by CMR

  6 months after myocardial infarction

Secondary Outcomes (8)

• Left ventricular ejection fraction (LVEF)

  6 months after myocardial infarction

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

  6 months after myocardial infarction

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

  6 months after myocardial infarction

• BNP

  6 months after myocardial infarction

• VO2 max

  6 months after myocardial infarction

Study Arms (3)

Fexofenadine hydrochloride 60mg bid

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.

Drug: Fexofenadine Hydrochloride 60mg bid

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.

Other: Placebo

Fexofenadine hydrochloride 120mg bid

EXPERIMENTAL

Fexofenadine hydrochloride 120mg bid was added to the standard treatment 3 days after the completion of primary PCI and CMR examination for 6 months.

Drug: Fexofenadine Hydrochloride 120mg bid

Interventions

Fexofenadine Hydrochloride 60mg bid DRUG

Fexofenadine hydrochloride 60mg bid treatment for 6 months.

Fexofenadine hydrochloride 60mg bid

Placebo OTHER

Placebo administration for 6 months.

Placebo

Fexofenadine Hydrochloride 120mg bid DRUG

Fexofenadine hydrochloride 120mg bid treatment for 6 months.

Fexofenadine hydrochloride 120mg bid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 within 12 hours of symptom onset;
• Ultrasonic cardiogram indicates regional wall motion abnormality, and transthoracic echocardiography shows LVEF ≤ 50% within 72 hours after revascularization.

You may not qualify if:

• 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;
• Concurrent severe infections, or liver/gallbladder obstruction, or history of malignant tumors;
• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

fexofenadine; BID protein, human

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Xinyang Hu, PhD

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yinchuan Xu, PhD

CONTACT

86-13968126628; lsyrmxyc@126.com

Feimu Zhang, MSt

CONTACT

86-18888915610; feimuzhang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 12, 2024
• Study Start: September 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share