Pexelizumab in Conjunction with Angioplasty in Acute Myocardial Infarction (APEX-AMI)

In the setting of reperfusion therapy in an acute myocardial infarction using primary percutaneous intervention (PCI), the body’s own inflammatory system involving the complement cascade may be harmful. This study will test the safety and efficacy of a novel complement inhibitor, pexelizumab to reduce mortality at 90 days.

Official Title

APEX-AMI

Conditions

Acute Myocardial Infarction

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Study Start

Eligibility & Criteria

Inclusion Criteria:- Cardiac symptoms for at least 20 minutes within past 6 hours; – Will undergo primary PCI; – Has ECG evidence of acute high risk ST elevation myocardial infarction; – Willing and able to be followed for at least 12 months. Exclusion Criteria:- Isolated low risk inferior wall myocardial infarction; – Received fibrinolytic therapy; – History of complement deficiency; – Suspected neiserial infection; – Participating in other investigational study; – Pregnancy; – Previous enrollment.

Total Enrolment

Contact Details

[1] Procter & Gamble Pharmaceuticals [2] Alexion Pharmaceuticals[3] Fremantle Hospital, Fremantle, Western Australia, 6160, Australia; Recruiting Randall Hendriks, MD 61 (0)8-9431-2025 Randall Hendriks, MD, Principal Investigator[4] Royal Perth Hospital, Perth, Western Australia, 6000, Australia; Recruiting Jamie Rankin, MD 61 (0)8-9224-2067 Jamie Rankin, MD, Principal Investigator[5] Sir Charles Gairdner Hospital, Nedlands, Western Australia, 6009, Australia; Recruiting Peter Thompson, MD 61 (0)8-9346-2677 Peter Thompson, MD, Principal Investigator