CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 9,406 enrolled
Drug / intervention
Eptifibatide (Integrilin) +1 moredrug
Likely dose
Eptifibatide 180 mcg/kg intravenous bolus followed by 2 mcg/kg/min infusion for 12–96 hours (or longer if needed for PCI or CABG)AI-extracted
Key inclusion· 4
  • ✓Symptoms of cardiac ischemia at rest (angina or equivalent) lasting ≥10 minutes
  • ✓Randomization within 12 hours of symptom onset
  • ✓Age ≥60 years OR ECG changes OR elevated troponin/CK-MB; OR all three: prior CVD history, elevated troponin/CK-MB, age 50-59
  • ✓Plan to undergo invasive strategy after study drug administration
Key exclusion· 7
  • ✕Pregnancy (known or suspected)
  • ✕Renal dialysis within 30 days prior to randomization
  • ✕Hemorrhagic stroke at any time or non-hemorrhagic stroke within 7 days
  • ✕CNS pathology (neoplasm, aneurysm, intracranial surgery)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00089895
NCT00089895Phase 3Completed
CompareCT.gov

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)

Organon and Co·interventional·Posted Aug 19, 2004·Updated May 17, 2024

In Brief

A Phase 3 clinical trial evaluating Eptifibatide (Integrilin) and Placebo for Myocardial Ischemia and Acute Coronary Syndrome. Completed, enrolled 9,406 participants.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyocardial Ischemia, Acute Coronary Syndrome
Countries--
CollaboratorsDuke Clinical Research Institute

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 19, 2004
Enrollment StartNov 1, 2004
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 21.9 years ago

Interventions

Eptifibatide (Integrilin)drug

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.

Placebodrug

intravenous; delivery to match eptifibatide to maintain blind