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Trial · NCT00089895

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

NCT00089895, Phase 3, Completed, Organon and Co; results first posted 2009-12-21

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED). Trials, record NCT00089895. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00089895

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
NCT number
NCT00089895
Status
Completed
Phases
Phase 3
Enrollment
9,406 participants, actual
Lead sponsor
Organon and Co
Conditions
Myocardial Ischemia, Acute Coronary Syndrome
Interventions
Eptifibatide (Integrilin), Placebo
First posted
2004-08-19
Last updated
2024-05-17
Results first posted
2009-12-21

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryIncidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out.96 hours after randomization
SecondaryIncidence of the Composite of Death/MI.30 days after randomization

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYIncidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out.96 hours after randomizationIntent to treat populationpercentage of participantsNUMBER
SECONDARYIncidence of the Composite of Death/MI.30 days after randomizationIntent to treat populationpercentage of participantsNUMBER

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out.Eptifibatide9.3percentage of participants
Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out.Placebo10.0percentage of participants
Incidence of the Composite of Death/MI.Eptifibatide11.2percentage of participants
Incidence of the Composite of Death/MI.Placebo12.3percentage of participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDEptifibatide4,722
Overall StudySTARTEDPlacebo4,684
Overall StudyCOMPLETEDEptifibatide4,687
Overall StudyCOMPLETEDPlacebo4,642
Overall StudyNOT COMPLETEDEptifibatide35
Overall StudyNOT COMPLETEDPlacebo42

Adverse events182

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
seriousANAEMIABlood and lymphatic system disordersEptifibatide14,6861
seriousANAEMIABlood and lymphatic system disordersPlacebo04,6430
seriousMICROCYTIC ANAEMIABlood and lymphatic system disordersEptifibatide14,6861
seriousMICROCYTIC ANAEMIABlood and lymphatic system disordersPlacebo04,6430
seriousPERICARDIAL EFFUSIONCardiac disordersEptifibatide04,6860
seriousPERICARDIAL EFFUSIONCardiac disordersPlacebo14,6431
seriousMIDDLE EAR INFLAMMATIONEar and labyrinth disordersEptifibatide04,6860
seriousMIDDLE EAR INFLAMMATIONEar and labyrinth disordersPlacebo14,6431
seriousADRENOCORTICAL INSUFFICIENCY ACUTEEndocrine disordersEptifibatide14,6861
seriousADRENOCORTICAL INSUFFICIENCY ACUTEEndocrine disordersPlacebo04,6430

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityEptifibatide
Total, all-cause mortalityPlacebo
Total, other adverse eventsEptifibatide04,686
Total, other adverse eventsPlacebo04,643
Total, serious adverse eventsEptifibatide664,686
Total, serious adverse eventsPlacebo604,643

Papers15

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
19332455DERIVEDPubMed
21300952DERIVEDPubMed
22373905DERIVEDPubMed
22645292DERIVEDPubMed
22995880DERIVEDPubMed
23416014DERIVEDPubMed
23537976DERIVEDPubMed
24016495DERIVEDPubMed
24093853DERIVEDPubMed
24562802DERIVEDPubMed

1 to 10 of 15

See all 15 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Eptifibatide vs Placebo: serious adverse events

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00089895

GET https://conductscience.org/api/trials/v1/NCT00089895/events?page=2