Status:
COMPLETED
Mangafodipir as an Adjunct to Percutaneous Coronary Intervention
Lead Sponsor:
Egetis Therapeutics
Conditions:
Myocardial Infarction
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
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...
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 stu...
Eligibility Criteria
Inclusion
- Males 40-80 and females 50-80 years with first severe coronary attack
- Chest pain up to 6 hours.
- T segment elevation (≥ 0.2 mV in two neighbouring anterior and inferior wall leads.
- Decided for treatment by primary PCI.
- TIMI grade 0 flow in the occluded LAD or RCA artery
- Written informed consent.
Exclusion
- Previous coronary artery bypass operation.
- Previous AMI.
- Chest pain more than 6 hours.
- Angina within 48 hours before admission.
- Cardiac arrest and cardiogenic shock.
- Occlusion of the left main stem, circumflex and right coronary arteries at angiography.
- Known hypersensitivity to mangafodipir (as contrast agent for MRI).
- Received mangafodipir ≤ 5 weeks before admission
- History of prior serious allergic or pseudo-allergic reaction
- Severely reduced liver or renal function
- Any other serious illness or medical condition
- Fertile females
- Phaeochromocytoma
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00966563
Start Date
December 1 2009
End Date
July 1 2013
Last Update
July 16 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Internal Medicine, County Hospital Ryhov
Jönköping, Sweden, 551 85