Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548204
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Effect and Safety of Fexofenadine Hydrochloride vs Placebo in Patients With Acute Myocardial Infaction A Randomized Clinical Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect and Safety of Fexofenadine Hydrochloride vs Placebo in Patients With Acute Myocardial Infaction A Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 single center randomized controlled clinical trial The study objects are STEMI patients left ventricular ejection fraction LVEF50 and primary PCI was performed within 12 hours of symptoms onset Participants will be randomly assigned to control group fexofenadine 60mg bid group or fexofenadine 120mg bid in a 111 ratio The control group will receive placebo for 6 months based on the standard treatment The fexofenadine 60mg bid group will receive fexofenadine hydrochloride 60mg bid 3 days after primary PCI for 6 months on the basis of standard treatment The fexofenadine 120mg bid group will receive fexofenadine hydrochloride 120mg bid 3 days after primary PCI for 6 months on the basis of standard treatment and all groups will be followed up for 6 months
Outcome measure The primary outcome is late gadolinium enhancementleft ventricular mass LGELV The secondary outcomes are left ventricular ejection fraction LVEF left ventricular internal dimension in systolebody surface area LVIDsBSA left ventricular internal dimension in diastolebody surface area LVIDdBSA BNP VO2 max SAQ scale score drug-associated adverse events and incidence of MACE
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 single center randomized controlled clinical trial The study objects are STEMI patients left ventricular ejection fraction LVEF50 and primary PCI was performed within 12 hours of symptoms onset Participants will be randomly assigned to control group fexofenadine 60mg bid group or fexofenadine 120mg bid in a 111 ratio The control group will receive placebo for 6 months based on the standard treatment The fexofenadine 60mg bid group will receive fexofenadine hydrochloride 60mg bid 3 days after primary PCI for 6 months on the basis of standard treatment The fexofenadine 120mg bid group will receive fexofenadine hydrochloride 120mg bid 3 days after primary PCI for 6 months on the basis of standard treatment and all groups will be followed up for 6 months
Outcome measure The primary outcome is late gadolinium enhancementleft ventricular mass LGELV The secondary outcomes are left ventricular ejection fraction LVEF left ventricular internal dimension in systolebody surface area LVIDsBSA left ventricular internal dimension in diastolebody surface area LVIDdBSA BNP VO2 max SAQ scale score drug-associated adverse events and incidence of MACE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None