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

Sponsor:	Procter and Gamble
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00091637

Purpose

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.

Condition	Intervention	Phase
Acute Myocardial Infarction	Drug: Pexelizumab Drug: Placebo infusion	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	APEX-AMI - Pexelizumab in Conjunction With Angioplasty

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Heart Attack

U.S. FDA Resources

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:

Reduction of all causes of mortality [ Time Frame: day 30 ] [ Designated as safety issue: No ]

Enrollment:	5745
Study Start Date:	April 2004
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo infusion	Drug: Placebo infusion bolus infusion over a 10 minute period once
Experimental: 2 Pexelizumab infusion	Drug: Pexelizumab Pexelizumab (2 mg/kg) intravenous , bolus for 10 minutes once

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091637

Show 349 Study Locations

Sponsors and Collaborators

Procter and Gamble

Investigators

Study Director:

Thomas G Todaro, MD, JD, FACC

Procter and Gamble

More Information

No publications provided by Procter and Gamble

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hudson MP, Armstrong PW, O'Neil WW, Stebbins AL, Weaver WD, Widimsky P, Aylward PE, Ruzyllo W, Holmes D, Mahaffey KW, Granger CB. Mortality implications of primary percutaneous coronary intervention treatment delays: insights from the assessment of pexelizumab in acute myocardial infarction trial. Circ Cardiovasc Qual Outcomes. 2011 Mar 1;4(2):183-92. Epub 2011 Feb 8.

Huber K, Holmes DR Jr, van 't Hof AW, Montalescot G, Aylward PE, Betriu GA, Widimsky P, Westerhout CM, Granger CB, Armstrong PW. Use of glycoprotein IIb/IIIa inhibitors in primary percutaneous coronary intervention: insights from the APEX-AMI trial. Eur Heart J. 2010 Jul;31(14):1708-16. Epub 2010 May 25.

Alhadramy O, Westerhout CM, Brener SJ, Granger CB, Armstrong PW; APEX AMI Investigators. Is visual interpretation of coronary epicardial flow reliable in patients with ST-elevation myocardial infarction undergoing primary angioplasty? Insights from the angiographic substudy of the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Am Heart J. 2010 May;159(5):899-904.

Patel MR, Worthley SG, Stebbins A, Dill T, Rademakers FE, Velleti US, Barsness GW, Van de Werf F, Hamm CW, Armstrong PW, Granger CB, Kim RJ. 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. JACC Cardiovasc Imaging. 2010 Jan;3(1):52-60. Epub 2010 Jan 12.

Trendelenburg M, Theroux P, Stebbins A, Granger C, Armstrong P, Pfisterer M. Influence of functional deficiency of complement mannose-binding lectin on outcome of patients with acute ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Eur Heart J. 2010 May;31(10):1181-7. Epub 2010 Jan 19.

Brener SJ, Westerhout CM, Fu Y, Todaro TG, Moliterno DJ, Wagner GS, Granger CB, Armstrong PW; APEX-AMI Investigators. Contribution of angiographic and electrocardiographic parameters of reperfusion to prediction of mortality and morbidity after acute ST-elevation myocardial infarction: Insights from the Assessment of Pexelizumab in Acute Myocardial Infarction trial. Am Heart J. 2009 Nov;158(5):755-60. Epub 2009 Oct 3.

Buller CE, Fu Y, Mahaffey KW, Todaro TG, Adams P, Westerhout CM, White HD, van 't Hof AW, Van de Werf FJ, Wagner GS, Granger CB, Armstrong PW. ST-segment recovery and outcome after primary percutaneous coronary intervention for ST-elevation myocardial infarction: insights from the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Circulation. 2008 Sep 23;118(13):1335-46. Epub 2008 Sep 8.

APEX AMI Investigators; Armstrong PW, Granger CB, Adams PX, Hamm C, Holmes D Jr, O'Neill WW, Todaro TG, Vahanian A, Van de Werf F. Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial. JAMA. 2007 Jan 3;297(1):43-51.

Responsible Party:	Thomas G Todaro, MD, JD, FACC, Procter and Gamble Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00091637 History of Changes
Other Study ID Numbers:	2003056
Study First Received:	September 14, 2004
Last Updated:	August 4, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis

Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 24, 2012