Full Text View
Tabular View
No Study Results Posted
Related Studies
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
This study has been completed.
Study NCT00089895   Information provided by Schering-Plough
First Received: August 17, 2004   Last Updated: December 17, 2008   History of Changes

August 17, 2004
December 17, 2008
November 2004
November 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00089895 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
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)

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.

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.

Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
  • Myocardial Ischemia
  • Acute Coronary Syndrome
  • Drug: Eptifibatide (Integrilin)
  • Drug: Placebo
  • Experimental: Eptifibatide in addition to standard of care.
  • Placebo Comparator: Placebo in addition to standard of care.
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
9500
November 2008
November 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00089895
Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
P03684
Schering-Plough
Duke University
 
Schering-Plough
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP