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

Conditions

Acute Myocardial Infarction

Brief summary

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 30 days.

Guptill JT, Mehta RH, Armstrong PW, Horton J, Laskowitz D, James S, Granger CB, Lopes RD.

2013-04-0241 citations

10.1161/circinterventions.112.000159

Mortality implications of primary percutaneous coronary intervention treatment delays: insights from the Assessment of Pexelizumab in Acute Myocardial Infarction trial.

Hudson MP, Armstrong PW, O'Neil WW, Stebbins AL, Weaver WD, Widimsky P, Aylward PE, Ruzyllo W, Holmes D, Mahaffey KW, Granger CB.

2011-02-0822 citations

10.1161/circoutcomes.110.945311

Influence of functional deficiency of complement mannose-binding lectin on outcome of patients with acute ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention.

Trendelenburg M, Theroux P, Stebbins A, Granger C, Armstrong P, Pfisterer M.

2010-01-1948 citations

10.1093/eurheartj/ehp597

Pexelizumab and infarct size in patients with acute myocardial infarction undergoing primary percutaneous coronary Intervention: a delayed enhancement cardiac magnetic resonance substudy from the APEX-AMI trial.

Patel MR, Worthley SG, Stebbins A, Dill T, Rademakers FE, Valeti US, Barsness GW, Van de Werf F, Hamm CW, Armstrong PW, Granger CB, Kim RJ.

2010-01-1236 citations

10.1016/j.jcmg.2009.09.014

Baseline Q-wave surpasses time from symptom onset as a prognostic marker in ST-segment elevation myocardial infarction patients treated with primary percutaneous coronary intervention.

Armstrong PW, Fu Y, Westerhout CM, Hudson MP, Mahaffey KW, White HD, Todaro TG, Adams PX, Aylward PE, Granger CB.

2009-04-0152 citations

10.1016/j.jacc.2009.01.046

Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial.

APEX AMI Investigators, Armstrong PW, Granger CB, Adams PX, Hamm C, Holmes D, O'Neill WW, Todaro TG, Vahanian A, Van de Werf F.

2007-01-01286 citations

10.1001/jama.297.1.43

Interventions

DRUGPexelizumab

Pexelizumab (2 mg/kg) intravenous , bolus for 10 minutes once

DRUGPlacebo infusion

bolus infusion over a 10 minute period once

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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 neisserial infection; * Participating in other investigational study; * Pregnancy; * Previous enrollment.

Design outcomes

Primary

Measure	Time frame
Reduction of all causes of mortality	day 30

Countries

Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Italy, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, Switzerland, United States

Outcome results

None listed