Mangafodipir as an Adjunct to Percutaneous Coronary Intervention

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Egetis Therapeutics; PledPharma AB
• Treatments: Edetic Acid; Pyridoxal Phosphate

Criteria

Inclusion Criteria:

1. Males 40-80 and females 50-80 years with first severe coronary attack

2. Chest pain up to 6 hours.

3. T segment elevation (≥ 0.2 mV in two neighbouring anterior and inferior wall leads.

4. Decided for treatment by primary PCI.

5. TIMI grade 0 flow in the occluded LAD or RCA artery

6. Written informed consent.

Exclusion Criteria:

1. Previous coronary artery bypass operation.

2. Previous AMI.

3. Chest pain more than 6 hours.

4. Angina within 48 hours before admission.

5. Cardiac arrest and cardiogenic shock.

6. Occlusion of the left main stem, circumflex and right coronary arteries at angiography.

7. Known hypersensitivity to mangafodipir (as contrast agent for MRI).

8. Received mangafodipir ≤ 5 weeks before admission

9. History of prior serious allergic or pseudo-allergic reaction

10. Severely reduced liver or renal function

11. Any other serious illness or medical condition

12. Fertile females

13. Phaeochromocytoma