Ignite Creation Date:
2024-07-17 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465303
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-13
Brief Title:
A Study of RTP-026 to Assess Safety Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction STEMI
Sponsor:
ResoTher Pharma
Organization:
ResoTher Pharma
Study Overview
Official Title:
An Exploratory Randomised Double-blind Multicentre Placebo-controlled Study of RTP-026 to Assess Safety Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction STEMI
Status:
RECRUITING
Status Verified Date:
2024-06
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 is an exploratory randomized double-blind multicentre placebo-controlled study of RTP-026
The study population will consist of men and women with documented evidence of ST-elevation myocardial infarction STEMI referred to primary Percutaneous Coronary Intervention PCI
The study population will consist of men and women with documented evidence of ST-elevation myocardial infarction STEMI referred to primary Percutaneous Coronary Intervention PCI
Detailed Description:
An exploratory randomized double-blind multicentre placebo-controlled study of RTP-026 to assess safety tolerability and efficacy in patients with STEMI
The study population is men between 18-80 years and post-menopausal women up to 80 years with documented evidence of STEMI referred to primary PCI with acute onset of chest pain lasting 12 hours and neutrophil to lymphocyte ratio NLR in the range of 7-17 at hospital admissionright after the PCI
They will be given three 30-minute intravenous infusions of RTP-026 or placebo the investigational product The first dose is to be initiated within 2 hours following the establishment of reflow after PCI and the following two study treatments with 8-hour intervals
The purpose of this study is to evaluate the safety tolerability and efficacy of RTP-026 versus placebo in multiple doses
The study population is men between 18-80 years and post-menopausal women up to 80 years with documented evidence of STEMI referred to primary PCI with acute onset of chest pain lasting 12 hours and neutrophil to lymphocyte ratio NLR in the range of 7-17 at hospital admissionright after the PCI
They will be given three 30-minute intravenous infusions of RTP-026 or placebo the investigational product The first dose is to be initiated within 2 hours following the establishment of reflow after PCI and the following two study treatments with 8-hour intervals
The purpose of this study is to evaluate the safety tolerability and efficacy of RTP-026 versus placebo in multiple doses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None