Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426537
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2024-05-17
Brief Title:
Colchicines Efficacy in MI Patients Comparing PCI and Non-Reperfusion Approaches
Sponsor:
University of Brawijaya
Organization:
University of Brawijaya
Study Overview
Official Title:
A Comparative Study of Colchicines Role in Reducing Cardiac Fibrosis in Acute Myocardial Infarction Patients Evaluating Outcomes With Percutaneous Coronary Intervention Versus Without Reperfusion
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study investigates the effect of Colchicine in preventing heart structure changes following ST-segment elevation myocardial infarction Through a clinical trial involving patients requiring coronary intervention we explore how Colchicine can reduce inflammation and fibrosis two crucial factors influencing heart failure post-heart attack The outcomes are expected to offer new insights into post-heart attack treatments to prevent heart failure
Detailed Description:
This clinical trial a prospective focuses on patients with ST-Elevation Myocardial Infarction STEMI requiring Percutaneous Coronary Intervention PCI within 12 hours of onset The study aims to control bias effectively through randomization evenly distributing confounding factors across two groups Patients unknown to both researchers and themselves whether receiving Colchicine or a placebo will undergo reperfusion therapy and optimal medicinal treatment according to the latest guidelines The study population includes all STEMI patients in three cities in East Java Jember Malang Tulungagung selected through purposive sampling The independent variable is Colchicine administration while dependent variables include ventricular remodeling assessed by Left Ventricular End-Diastolic Volume LVEDV via echocardiography serum levels of caspase-1 TGF-β NT pro BNP and Galectin-3 All patients receive standard medical treatment pre-PCI including aspirin and antiplatelet drugs with post-PCI Optical Medical Treatment OMT following the latest guidelines
The trial is randomized double-blinded and placebo-controlled with participants divided into four groups early PCI with Colchicine or placebo and STEMI without reperfusion receiving either Colchicine or placebo This setup allows for a comprehensive comparison across different patient management strategies exploring Colchicines potential benefits in post-AMI care and its effects on key inflammatory and fibrotic markers
The trial is randomized double-blinded and placebo-controlled with participants divided into four groups early PCI with Colchicine or placebo and STEMI without reperfusion receiving either Colchicine or placebo This setup allows for a comprehensive comparison across different patient management strategies exploring Colchicines potential benefits in post-AMI care and its effects on key inflammatory and fibrotic markers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None