CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 2,022 enrolled
Drug / intervention
Abciximab +1 moredrug
Likely dose
Abciximab 0.25 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00133003
NCT00133003Phase 4Completed
CompareCT.gov

Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of the Glycoprotein IIb/IIIa Inhibition With Abciximab in Patients With ACS Undergoing Coronary Stenting After Pretreatment With a High Loading Dose of Clopidogrel (ISAR-REACT-2)

Deutsches Herzzentrum Muenchen·interventional·Posted Aug 22, 2005·Updated Apr 15, 2008

In Brief

A Phase 4 clinical trial evaluating Abciximab and Placebo for Coronary Disease and Angina, Unstable. Completed, enrolled 2,022 participants across 5 sites in 3 countries.

Detailed Summary

The purpose of this study is to determine whether there is any additional benefit from abciximab administration during percutaneous coronary intervention in patients presenting with acute coronary syndromes after pre-treatment with 600mg of clopidogrel.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Disease, Angina, Unstable
CountriesBrazil, Germany, Netherlands
CollaboratorsTechnical University of Munich

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 22, 2005
Enrollment StartMar 1, 2003
Primary CompletionJan 1, 2006
TodayJul 1, 2026
Enrollment to primary: 2.8 yearsPosted 20.9 years ago

Interventions

Abciximabdrug

0.25 mg/kg of body weight bolus, followed by a 0.125-microg/kg per minute \[maximum, 10 microg/min\] infusion for 12 hours, plus heparin, 70 U/kg of body weight

Placebodrug

Placebo consist of placebo bolus and infusion of 12 hours (NaCl 0.9%), plus heparin bolus, 140 U/kg of body weight