CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,461 enrolled
Drug / intervention
abciximab placebo; reteplase placebo, abciximab, abciximab +5 moredrug
Likely dose
Abciximab 0.25 mg/kg intravenous bolus followed by 0.125 mcg/kg/min infusion (max 10 mcg/min) for 12 hours, with or without reteplase 1-2 five-unit bolusesAI-extracted
Key inclusion· 3
  • ✓Acute myocardial infarction with prolonged, continuous ischemic signs and symptoms lasting ≥20 minutes, not relieved by nitrates
  • ✓Symptom onset within 6 hours of randomization
  • ✓Electrocardiographic confirmation of acute MI
Key exclusion· 2
  • ✕Low-risk clinical presentation
  • ✕Will not undergo cardiac catheterization within 4 hours of the qualifying ECG

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

Search/NCT00046228
NCT00046228Phase 3Completed
CompareCT.gov

A Muticenter, Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy and Safety of Reteplease and Abciximab Combination Therapy With Abciximab Alone Administered Early or Just Prior to Primary Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction.

Centocor, Inc.·interventional·Posted Sep 25, 2002·Updated Jul 31, 2014

In Brief

A Phase 3 clinical trial evaluating abciximab placebo; reteplase placebo, abciximab, abciximab, Abciximab; reteplase; abciximab placebo; abciximab, and 1 other intervention for Myocardial Infarction. Completed, enrolled 2,461 participants across 227 sites in 19 countries.

Detailed Summary

The purpose of this study is to determine whether abciximab given in combination with reteplase, before patients have a coronary intervention (a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot), is safe and effective in the treatment of heart attacks compared to only abciximab given during coronary intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyocardial Infarction
CountriesArgentina, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Israel, Netherlands, Poland, Romania, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 25, 2002
Enrollment StartAug 1, 2002
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 23.8 years ago

Interventions

abciximab placebo; reteplase placebo, abciximab, abciximabdrug

placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h

Abciximab; reteplase; abciximab placebo; abciximabdrug

0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h

abciximab; reteplase placebo; abciximab placebo; abciximabdrug

0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h

abciximab placebo; reteplase placebo, abciximab, abciximabdrug

placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h

abciximab; reteplase placebo; abciximab placebo; abciximabdrug

0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h

Abciximab; reteplase; abciximab placebo; abciximabdrug

0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h