Ignite Creation Date:
2024-05-05 @ 9:47 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00966563
Status:
COMPLETED
Last Update Posted:
2013-07-16
First Post:
2009-08-26
Brief Title:
Mangafodipir as an Adjunct to Percutaneous Coronary Intervention
Sponsor:
Egetis Therapeutics
Organization:
Egetis Therapeutics
Study Overview
Official Title:
Mangafodipir as an Adjunct to Percutaneous Coronary Intervention in Acute Myocardial Infarction MANAMI
Status:
COMPLETED
Status Verified Date:
2013-07
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:
MANAMI
Brief Summary:
The present feasibility study is designed to find out whether pre-treatment with the compound mangafodipir PP-099 provides an additional reduction in myocardial infarct size in patients treated with primary percutaneous coronary intervention PCI during acute myocardial infarction AMI
Detailed Description:
Mangafodipir manganese Mn dipyridoxyl diphosphate MnDPDP and its lipophile metabolite Mn dipyridoxyl diethylene diamide MnPLED are catalytic antioxidants and iron chelators In preclinical studies these agents reduce oxidative stress induced injuries related to chemotherapy of cancer and to reperfusionreoxygenation of ischemichypoxic myocardium Accordingly in an in vivo pig model of AMI metabolite MnPLED applied at end of ischemia and during reperfusion reduced myocardial infarct size by 55 Mangafodipir most likely activates salvage pathways and prevents lethal reperfusion injuries
Other advantages are that mangafodipir is already approved as a contrast agent for MRI of liver and that the experience for more than a decade reveals a high safety with minor and tolerable side-effects
The present study will include 20 patients treated for their first documented AMI They will after admission to hospital undergo primary PCI Reopening of an occluded coronary artery will be preceded by iv infusion of mangafodipir or placebo in two groups each consisting of 10 patients The primary endpoint will be release to plasma of commonly accepted biomarkers of myocardial injury Troponin T and CK-MB measured at admission and 6 hours after PCI The secondary endpoints include the accumulated release of plasma biomarkers over 48 hours and direct measurement of the final myocardial infarct size at 6-10 weeks after PCI
Other advantages are that mangafodipir is already approved as a contrast agent for MRI of liver and that the experience for more than a decade reveals a high safety with minor and tolerable side-effects
The present study will include 20 patients treated for their first documented AMI They will after admission to hospital undergo primary PCI Reopening of an occluded coronary artery will be preceded by iv infusion of mangafodipir or placebo in two groups each consisting of 10 patients The primary endpoint will be release to plasma of commonly accepted biomarkers of myocardial injury Troponin T and CK-MB measured at admission and 6 hours after PCI The secondary endpoints include the accumulated release of plasma biomarkers over 48 hours and direct measurement of the final myocardial infarct size at 6-10 weeks after PCI
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