EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED) - Full Text View

Purpose

The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention (surgery) compared to placebo (with delayed provisional use of eptifibatide).

Condition	Intervention	Phase
Myocardial Ischemia Acute Coronary Syndrome	Drug: Eptifibatide (Integrilin) Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Early Glycoprotein IIb/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome: A Randomized, Placebo-Controlled Trial Evaluating the Clinical Benefits of Early Front-loaded Eptifibatide in the Treatment of Patients With Non-ST-segment Elevation Acute Coronary Syndrome (EARLY ACS)

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Coronary Artery Bypass Surgery Coronary Artery Disease Heart Attack

Drug Information available for: Heparin Eptifibatide

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out. [ Time Frame: 96 hours after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of the Composite of Death/MI. [ Time Frame: 30 days after randomization ] [ Designated as safety issue: No ]

Enrollment:	9406
Study Start Date:	November 2004
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Eptifibatide Eptifibatide in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.	Drug: Eptifibatide (Integrilin) intravenous; 180 mcg/kg bolus followed by infusion of 2 mcg/kg/min for 12 to 96 hours (or longer if necessary to complete the 18- to 24-hour post-PCI infusion period, or up to 120 hours in patients who proceed to CABG [coronary artery bypass graft]); second bolus of 180 mcg/kg administered 10 minutes after first bolus. Other Names: Integrilin SCH 060936 SCH 60936
Placebo Comparator: Placebo Placebo in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.	Drug: Placebo intravenous; delivery to match eptifibatide to maintain blind

Arms

Assigned Interventions

Experimental: Eptifibatide

Eptifibatide in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.

Drug: Eptifibatide (Integrilin)

intravenous; 180 mcg/kg bolus followed by infusion of 2 mcg/kg/min for 12 to 96 hours (or longer if necessary to complete the 18- to 24-hour post-PCI infusion period, or up to 120 hours in patients who proceed to CABG [coronary artery bypass graft]); second bolus of 180 mcg/kg administered 10 minutes after first bolus.

Other Names:

Integrilin
SCH 060936
SCH 60936

Placebo Comparator: Placebo

Placebo in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.

Drug: Placebo

intravenous; delivery to match eptifibatide to maintain blind

Detailed Description:

This study will enroll patients who experience symptoms of acute coronary syndrome (experiencing chest pain at rest with episodes lasting at least 10 minutes) and who are planned to undergo invasive surgical procedures after being given study drug for 12 to 96 hours. There are two different treatment groups in this study; approximately half of the patients will go to each group and the likelihood of receiving study drug vs. placebo is 50/50 (like tossing a coin). Medications that are standard of care will be provided to the patients (all patients will be given aspirin and standard hospital doses of one of two other blood thinning drugs - unfractionated heparin (UFH) or low-molecular-weight heparin). Which one patients receive is at the discretion of the Investigator.

Eligibility

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

Criteria

Inclusion Criteria:

Willing and able to give informed consent and comply with study procedures and follow-up through 1 year.
Plan to undergo an invasive strategy after receiving study drug for 12 to 96 hours.
Able to be randomized into the trial within 12 hours of having symptoms of acute coronary syndrome.
Experiencing symptoms of cardiac ischemia at rest (angina or anginal equivalent) with episode(s) lasting at least 10 minutes and have at least 2 of the following:
- 60 years of age or more
- Electrocardiogram changes (ECG)
- Elevated troponin (protein released in the blood stream in people suffering from acute coronary syndrome) or CK-MB levels
Or have all 3 of the following:
- Prior history of cardiovascular disease
- Elevated troponin or CK-MB levels
- 50-59 years of age

Exclusion Criteria:

pregnancy (known or suspected)
renal dialysis within 30 days prior to randomizing in study
other serious illnesses or any condition that the investigator feels would pose a significant hazard to the patient if the investigational therapy was to be initiated
Stroke (hemorrhagic stroke at any time or non-hemorrhagic stroke within previous 7 days), central nervous system damage (such as neoplasm, aneurysm, intracranial surgery), bleeding disorders (including gastrointestinal bleeding), or recent major surgery or major trauma.
History of certain hematologic problems following treatment with heparin or eptifibatide.
Therapy with certain related drugs within a short time before randomization into the trial.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided by Schering-Plough

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

Klutstein MW, Westerhout CM, Armstrong PW, Giugliano RP, Lewis BS, Gibson CM, Lutchmedial S, Widimsky P, Steg PG, Dalby A, Zeymer U, Van de Werf F, Harrington RA, Newby LK, Rao SV. Radial versus femoral access, bleeding and ischemic events in patients with non-ST-segment elevation acute coronary syndrome managed with an invasive strategy. Am Heart J. 2013 Apr;165(4):583-590.e1. doi: 10.1016/j.ahj.2013.01.009. Epub 2013 Feb 22.

Pride YB, Mohanavelu S, Zorkun C, Kunadian V, Giugliano RP, Newby LK, Braunwald E, Califf RM, Harrington RA, Gibson CM; EARLY ACS Investigators. Association between angiographic complications and clinical outcomes among patients with acute coronary syndrome undergoing percutaneous coronary intervention: an EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non-ST-Segment Elevation Acute Coronary Syndrome) angiographic substudy. JACC Cardiovasc Interv. 2012 Sep;5(9):927-35. doi: 10.1016/j.jcin.2012.05.007. PubMed PMID: 22995880.

Roe MT, White JA, Kaul P, Tricoci P, Lokhnygina Y, Miller CD, van't Hof AW, Montalescot G, James SK, Saucedo J, Ohman EM, Pollack CV Jr, Hochman JS, Armstrong PW, Giugliano RP, Harrington RA, Van de Werf F, Califf RM, Newby LK. Regional patterns of use of a medical management strategy for patients with non-ST-segment elevation acute coronary syndromes: insights from the EARLY ACS Trial. Circ Cardiovasc Qual Outcomes. 2012 Mar 1;5(2):205-13. Epub 2012 Feb 28.

Wang TY, White JA, Tricoci P, Giugliano RP, Zeymer U, Harrington RA, Montalescot G, James SK, Van de Werf F, Armstrong PW, Braunwald E, Califf RM, Newby LK. Upstream clopidogrel use and the efficacy and safety of early eptifibatide treatment in patients with acute coronary syndrome: an analysis from the Early Glycoprotein IIb/IIIa Inhibition in Patients with Non-ST-Segment Elevation Acute Coronary Syndrome (EARLY ACS) trial. Circulation. 2011 Feb 22;123(7):722-30. Epub 2011 Feb 7.

Giugliano RP, White JA, Bode C, Armstrong PW, Montalescot G, Lewis BS, van 't Hof A, Berdan LG, Lee KL, Strony JT, Hildemann S, Veltri E, Van de Werf F, Braunwald E, Harrington RA, Califf RM, Newby LK; EARLY ACS Investigators. Early versus delayed, provisional eptifibatide in acute coronary syndromes. N Engl J Med. 2009 May 21;360(21):2176-90. Epub 2009 Mar 30.

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00089895 History of Changes
Other Study ID Numbers:	P03684
Study First Received:	August 17, 2004
Results First Received:	November 13, 2009
Last Updated:	March 11, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

myocardial infarction
acute coronary syndrome
non-ST-segment elevation
eptifibatide
Integrilin
glycoprotein IIb/IIIa inhibitor (GP IIb/IIIa)
percutaneous coronary intervention (PCI)

coronary artery bypass graph surgery (CABG)
catheterization
angina
ischemia
cardiac ischemia
cardiovascular disease

Additional relevant MeSH terms:

Myocardial Ischemia
Coronary Artery Disease
Ischemia
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

Krestin
Heparin, Low-Molecular-Weight
Eptifibatide
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Interferon Inducers
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 19, 2013