NCT00089895

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,406

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2004

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2004

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2004

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 21, 2009

Completed
Last Updated

May 17, 2024

Status Verified

February 1, 2022

Enrollment Period

4 years

First QC Date

August 17, 2004

Results QC Date

November 13, 2009

Last Update Submit

May 8, 2024

Conditions

Myocardial IschemiaAcute Coronary Syndrome

Keywords

myocardial infarctionacute coronary syndromenon-ST-segment elevationeptifibatideIntegrilinglycoprotein IIb/IIIa inhibitor (GP IIb/IIIa)percutaneous coronary intervention (PCI)coronary artery bypass graph surgery (CABG)catheterizationanginaischemiacardiac ischemiacardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out.

    96 hours after randomization

Secondary Outcomes (1)

  • Incidence of the Composite of Death/MI.

    30 days after randomization

Study Arms (2)

Eptifibatide

EXPERIMENTAL

Eptifibatide in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.

Drug: Eptifibatide (Integrilin)

Placebo

PLACEBO COMPARATOR

Placebo in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.

Drug: Placebo

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.

Also known as: Integrilin, SCH 060936, SCH 60936
Eptifibatide
PlaceboDRUG

intravenous; delivery to match eptifibatide to maintain blind

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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
  • years of age

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

    PMID: 35224730DERIVED

  • Furtado RHM, Nicolau JC, Guo J, Im K, White JA, Sabatine MS, Newby LK, Giugliano RP. Morphine and Cardiovascular Outcomes Among Patients With Non-ST-Segment Elevation Acute Coronary Syndromes Undergoing Coronary Angiography. J Am Coll Cardiol. 2020 Jan 28;75(3):289-300. doi: 10.1016/j.jacc.2019.11.035.

    PMID: 31976867DERIVED

  • Farhan S, Clare RM, Jarai R, Giugliano RP, Lokhnygina Y, Harrington RA, Kristin Newby L, Huber K. Fasting glucose, NT-proBNP, treatment with eptifibatide, and outcomes in non-ST-segment elevation acute coronary syndromes: An analysis from EARLY ACS. Int J Cardiol. 2017 Apr 1;232:264-270. doi: 10.1016/j.ijcard.2017.01.007. Epub 2017 Jan 4.

    PMID: 28089149DERIVED

  • Kragholm K, Goldstein SA, Yang Q, Lopes RD, Schulte PJ, Bernacki GM, White HD, Mahaffey KW, Giugliano RP, Armstrong PW, Harrington RA, Tricoci P, Van de Werf F, Alexander JH, Alexander KP, Newby LK. Trends in Enrollment, Clinical Characteristics, Treatment, and Outcomes According to Age in Non-ST-Segment-Elevation Acute Coronary Syndromes Clinical Trials. Circulation. 2016 Apr 19;133(16):1560-73. doi: 10.1161/CIRCULATIONAHA.115.017299. Epub 2016 Mar 8.

    PMID: 26957532DERIVED

  • Kunadian V, Giugliano RP, Newby LK, Zorkun C, Guo J, Bagai A, Montalescot G, Braunwald E, Califf RM, Van de Werf F, Armstrong PW, Harrington R, Gibson CM. Angiographic outcomes with early eptifibatide therapy in non-ST-segment elevation acute coronary syndrome (from the EARLY ACS Trial). Am J Cardiol. 2014 Apr 15;113(8):1297-305. doi: 10.1016/j.amjcard.2014.01.404. Epub 2014 Jan 31.

    PMID: 24607027DERIVED

  • De Ferrari GM, Fox KA, White JA, Giugliano RP, Tricoci P, Reynolds HR, Hochman JS, Gibson CM, Theroux P, Harrington RA, Van de Werf F, White HD, Califf RM, Newby LK. Outcomes among non-ST-segment elevation acute coronary syndromes patients with no angiographically obstructive coronary artery disease: observations from 37,101 patients. Eur Heart J Acute Cardiovasc Care. 2014 Mar;3(1):37-45. doi: 10.1177/2048872613489315. Epub 2013 May 9.

    PMID: 24562802DERIVED

  • Kaul P, Tanguay JF, Newby LK, Hochman JS, Westerhout CM, Califf RM, Tricoci P, Gibson CM, Giugliano RP, Harrington RA, Van de Werf F, Armstrong PW. Association between bleeding and mortality among women and men with high-risk acute coronary syndromes: insights from the Early versus Delayed, Provisional Eptifibatide in Acute Coronary Syndromes (EARLY ACS) trial. Am Heart J. 2013 Oct;166(4):723-8. doi: 10.1016/j.ahj.2013.07.014. Epub 2013 Sep 5.

    PMID: 24093853DERIVED

  • Bagai A, White JA, Lokhnygina Y, Giugliano RP, Van de Werf F, Montalescot G, Armstrong PW, Tricoci P, Gibson CM, Califf RM, Harrington RA, Newby LK. Routine early eptifibatide versus delayed provisional use at percutaneous coronary intervention in high-risk non-ST-segment elevation acute coronary syndromes patients: an analysis from the Early Glycoprotein IIb/IIIa Inhibition in Non-ST-Segment Elevation Acute Coronary Syndrome trial. Am Heart J. 2013 Sep;166(3):466-73. doi: 10.1016/j.ahj.2013.05.019. Epub 2013 Jul 25.

    PMID: 24016495DERIVED

  • Klutstein MW, Westerhout CM, Armstrong PW, Giugliano RP, Lewis BS, Gibson CM, Lutchmedial S, Widimsky P, Steg PG, Dalby A, Zeymer U, Van de Werf F, Harrington RA, Newby LK, Rao SV. Radial versus femoral access, bleeding and ischemic events in patients with non-ST-segment elevation acute coronary syndrome managed with an invasive strategy. Am Heart J. 2013 Apr;165(4):583-590.e1. doi: 10.1016/j.ahj.2013.01.009. Epub 2013 Feb 22.

    PMID: 23537976DERIVED

  • Ezekowitz JA, Bakal JA, Westerhout CM, Giugliano RP, White H, Keltai M, Prabhakaran D, Tricoci P, Van de Werf F, Califf RM, Newby LK, Armstrong PW. The relationship between meteorological conditions and index acute coronary events in a global clinical trial. Int J Cardiol. 2013 Oct 3;168(3):2315-21. doi: 10.1016/j.ijcard.2013.01.061. Epub 2013 Feb 14.

    PMID: 23416014DERIVED

  • Pride YB, Mohanavelu S, Zorkun C, Kunadian V, Giugliano RP, Newby LK, Braunwald E, Califf RM, Harrington RA, Gibson CM; EARLY ACS Investigators. Association between angiographic complications and clinical outcomes among patients with acute coronary syndrome undergoing percutaneous coronary intervention: an EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non-ST-Segment Elevation Acute Coronary Syndrome) angiographic substudy. JACC Cardiovasc Interv. 2012 Sep;5(9):927-35. doi: 10.1016/j.jcin.2012.05.007.

    PMID: 22995880DERIVED

  • Piccini JP, White JA, Mehta RH, Lokhnygina Y, Al-Khatib SM, Tricoci P, Pollack CV Jr, Montalescot G, Van de Werf F, Gibson CM, Giugliano RP, Califf RM, Harrington RA, Newby LK. Sustained ventricular tachycardia and ventricular fibrillation complicating non-ST-segment-elevation acute coronary syndromes. Circulation. 2012 Jul 3;126(1):41-9. doi: 10.1161/CIRCULATIONAHA.111.071860. Epub 2012 May 29.

    PMID: 22645292DERIVED

  • Roe MT, White JA, Kaul P, Tricoci P, Lokhnygina Y, Miller CD, van't Hof AW, Montalescot G, James SK, Saucedo J, Ohman EM, Pollack CV Jr, Hochman JS, Armstrong PW, Giugliano RP, Harrington RA, Van de Werf F, Califf RM, Newby LK. Regional patterns of use of a medical management strategy for patients with non-ST-segment elevation acute coronary syndromes: insights from the EARLY ACS Trial. Circ Cardiovasc Qual Outcomes. 2012 Mar 1;5(2):205-13. doi: 10.1161/CIRCOUTCOMES.111.962332. Epub 2012 Feb 28.

    PMID: 22373905DERIVED

  • Wang TY, White JA, Tricoci P, Giugliano RP, Zeymer U, Harrington RA, Montalescot G, James SK, Van de Werf F, Armstrong PW, Braunwald E, Califf RM, Newby LK. Upstream clopidogrel use and the efficacy and safety of early eptifibatide treatment in patients with acute coronary syndrome: an analysis from the Early Glycoprotein IIb/IIIa Inhibition in Patients with Non-ST-Segment Elevation Acute Coronary Syndrome (EARLY ACS) trial. Circulation. 2011 Feb 22;123(7):722-30. doi: 10.1161/CIRCULATIONAHA.110.958041. Epub 2011 Feb 7.

    PMID: 21300952DERIVED

  • 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. doi: 10.1056/NEJMoa0901316. Epub 2009 Mar 30.

    PMID: 19332455DERIVED

MeSH Terms

Conditions

Myocardial IschemiaAcute Coronary SyndromeMyocardial InfarctionAngina PectorisIschemiaCoronary Artery DiseaseCardiovascular Diseases

Interventions

Eptifibatide

Condition Hierarchy (Ancestors)

Heart DiseasesVascular DiseasesInfarctionPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisChest PainPainNeurologic ManifestationsSigns and SymptomsCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2004

First Posted

August 19, 2004

Study Start

November 1, 2004

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

May 17, 2024

Results First Posted

December 21, 2009

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share