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

Sponsor:	Schering-Plough
Collaborator:	Duke University
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00089895

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.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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: Coronary Artery Bypass Surgery Heart Attack Surgery

Drug Information available for: Krestin 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:

Key secondary outcome is incidence of the composite of death/MI. [ Time Frame: 30 days after randomization ] [ Designated as safety issue: No ]
Incidences of (1) MI and (2) the composite of death/MI. [ Time Frame: 96 hours after randomization ] [ Designated as safety issue: No ]
Incidence of the composite of death/MI/RI-UR [ Time Frame: 30 days after randomization ] [ Designated as safety issue: No ]
Incidence of death. [ Time Frame: 30 days, 6 months, and 1 year after randomization ] [ Designated as safety issue: No ]

Estimated Enrollment:	9500
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
Eptifibatide: Experimental Eptifibatide in addition to standard of care.	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.
Placebo: Placebo Comparator Placebo in addition to standard of care.	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

Additional Information:

website containing information on the trial This link exits the ClinicalTrials.gov site

No publications provided by Schering-Plough

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P03684
Study First Received:	August 17, 2004
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00089895 History of Changes
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:

Anti-Infective Agents
Interferon Inducers
Radiation-Protective Agents
Immunologic Factors
Antineoplastic Agents
Myocardial Ischemia
Physiological Effects of Drugs
Hematologic Agents
Antibiotics, Antineoplastic
Pathologic Processes
Syndrome
Therapeutic Uses
Cardiovascular Diseases

Eptifibatide
Heart Diseases
Disease
Adjuvants, Immunologic
Vascular Diseases
Ischemia
Antiviral Agents
Protective Agents
Pharmacologic Actions
Acute Coronary Syndrome
Platelet Aggregation Inhibitors
PS-K

ClinicalTrials.gov processed this record on November 05, 2009