Myocardial IschemiaPhase 3NCT00089895
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
A Phase 3 study testing Eptifibatide (Integrilin) in people with Myocardial Ischemia and Acute Coronary Syndrome, run by Organon and Co.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia, Acute Coronary Syndrome
- What is being tested?
- Eptifibatide (Integrilin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9,406 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2004to 1 Nov 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 60 years of age or more
- Electrocardiogram changes (ECG)
Show all 11Show fewer
- 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
- 50-59 years of age
Who cannot join
- 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.
About this study
Official title: 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)
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).
Read the detailed description
This study will enroll patients who experience symptoms of acute coronary syndrome (experiencing chest pain at rest with episodes lasting at least 10 minutes) and who are planned to undergo invasive surgical procedures after being given study drug for 12 to 96 hours. There are two different treatment groups in this study; approximately half of the patients will go to each group and the likelihood of receiving study drug vs. placebo is 50/50 (like tossing a coin). Medications that are standard of care will be provided to the patients (all patients will be given aspirin and standard hospital doses of one of two other blood thinning drugs - unfractionated heparin (UFH) or low-molecular-weight heparin). Which one patients receive is at the discretion of the Investigator.
- Conditions
- Myocardial Ischemia, Acute Coronary Syndrome
- Being tested
- Eptifibatide (Integrilin), Placebo
- Keywords
- myocardial infarction, acute coronary syndrome, non-ST-segment elevation, eptifibatide, Integrilin, glycoprotein IIb/IIIa inhibitor (GP IIb/IIIa), percutaneous coronary intervention (PCI), coronary artery bypass graph surgery (CABG), catheterization, angina, ischemia, cardiac ischemia, cardiovascular disease
- Medical subject headings
- Myocardial Ischemia, Acute Coronary Syndrome, Myocardial Infarction, Angina Pectoris, Ischemia, Coronary Artery Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eptifibatide (Integrilin)Drug
Also called Integrilin, SCH 060936, SCH 60936
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
| Study group | Role | What they receive |
|---|---|---|
| Eptifibatide | Experimental | Eptifibatide in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out.
Measured: 96 hours after randomization
Secondary outcomes (1)
Incidence of the Composite of Death/MI.
Measured: 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2004 (estimated)
- Study start1 Nov 2004
- Primary completion1 Nov 2008
- Study completion1 Nov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9,406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00089895
- Sponsor's protocol ID
- P03684
- Status last verified
- Feb 2022
- First submitted
- 17 Aug 2004
- Last updated
- 17 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35224730Furtado 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.
PubMed 31976867Farhan 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.
PubMed 28089149Kragholm 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.
PubMed 26957532Kunadian 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.
PubMed 24607027De 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.
PubMed 24562802Kaul 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.
PubMed 24093853Bagai 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.
PubMed 24016495Klutstein 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.
PubMed 23537976Ezekowitz 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.
PubMed 23416014Pride 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.
PubMed 22995880Piccini 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.
PubMed 22645292Roe 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.
PubMed 22373905Wang 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.
PubMed 21300952Giugliano 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.
PubMed 19332455
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00089895
- Acronym / sponsor ID
- P03684
- Conditions
- Myocardial Ischemia, Acute Coronary Syndrome
- Keywords
- myocardial infarction, acute coronary syndrome, non-ST-segment elevation, eptifibatide, Integrilin, glycoprotein IIb/IIIa inhibitor (GP IIb/IIIa), percutaneous coronary intervention (PCI), coronary artery bypass graph surgery (CABG)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,406 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute
- Study start
- 1 Nov 2004 (actual)
- Primary completion
- 1 Nov 2008 (actual)
- Study completion
- 1 Nov 2008 (actual)
- First posted
- 19 Aug 2004 (estimated)
- Results
- Posted 21 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This study will enroll patients who experience symptoms of acute coronary syndrome (experiencing chest pain at rest with episodes lasting at least 10 minutes) and who are planned to undergo invasive surgical procedures after being given study drug for 12 to 96 hours. There are two different treatment groups in this study; approximately half of the patients will go to each group and the likelihood of receiving study drug vs. placebo is 50/50 (like tossing a coin). Medications that are standard of care will be provided to the patients (all patients will be given aspirin and standard hospital doses of one of two other blood thinning drugs - unfractionated heparin (UFH) or low-molecular-weight heparin). Which one patients receive is at the discretion of the Investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eptifibatide | Experimental | Drug: Eptifibatide (Integrilin)Eptifibatide in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Or have all 3 of the following:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eptifibatide (Integrilin)Also: Integrilin, SCH 060936, SCH 60936intravenous; 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. | Drug | Eptifibatide |
| Placebointravenous; delivery to match eptifibatide to maintain blind | Drug | Placebo |
Primary outcome
Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out.
Time frame: 96 hours after randomization
1 secondary outcome
Incidence of the Composite of Death/MI.
Time frame: 30 days after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35224730Natale 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.
- Derived from this study: PubMed 31976867Furtado 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.
- Derived from this study: PubMed 28089149Farhan 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.
- Derived from this study: PubMed 26957532Kragholm 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.
- Derived from this study: PubMed 24607027Kunadian 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.
- Derived from this study: PubMed 24562802De 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.
- Derived from this study: PubMed 24093853Kaul 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.
- Derived from this study: PubMed 24016495Bagai 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.
- Derived from this study: PubMed 23537976Klutstein 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.
- Derived from this study: PubMed 23416014Ezekowitz 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.
- Derived from this study: PubMed 22995880Pride 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.
- Derived from this study: PubMed 22645292Piccini 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eptifibatide (Integrilin) in people with Myocardial Ischemia and Acute Coronary Syndrome, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out. (time frame: 96 hours after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00089895, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.