Myocardial InfarctionPhase 3ESTEEMNCT00812435
Eptifibatide and ST Segment Resolution Following Primary PCI
A Phase 3 study testing eptifibitide in people with Myocardial Infarction, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
This is a prospective, open label, randomized trial of 100 patients who present to the cardiac catheterization laboratory with an ST Elevation Myocardial Infarction for primary PCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- eptifibitide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Mar 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Patients >18 years old
- Patients with acute myocardial infarction whose symptom onset is within 12 hours of presentation
- ST-segment elevation 1 mm in 2 contiguous limb leads or 2 mm in 2 contiguous precordial leads
- Patients eligible for PCI
- Target lesion(s) in a native vessel
- Target lesion stenosis >50% by angiography (visual estimate)
- Patients who are amenable to participating in study procedures and follow-up
- Patient or legal guardian has been informed and agrees to provide approved written informed consent and data privacy authorization
Who cannot join
- Patients with cardiogenic shock (SBP<80 mmHg for >30 minutes or requiring pressors or IABP due to hypotension)
- Patients with cardiac arrest at any point prior to intervention (within the preceeding 24 hours)
- Patients on chronic warfarin (Coumadin) therapy
- Patients with known bleeding diathesis or active bleeding at the time of presentation to the catheterization laboratory
- Patients with known bleeding diathesis or active bleeding within prior 3 months
- Patients who receive thrombolytic therapy or glycoprotein IIb/IIIa inhibitors prior to PCI (within the preceding 8 hours)
Show all 17Show fewer
- Patients with a platelet count <100,000 cells/mm3 within the preceeding 7 days
- Patients with known allergies to aspirin, clopidogrel bisulfate (Plavix), heparin, bivalirudin, glycoprotein IIb/IIIa inhibitors or intravenous contrast dye that cannot be medically managed
- Patients with major surgery within the past 6 months or scheduled surgery within 6 weeks
- Patients with significant unprotected left main disease (stenosis >60%) or with multivessel coronary disease that will require emergent coronary artery bypass surgery
- Patients with TIA or CVA within the past 30 days or any history of hemorrhagic stroke
- Patients who have undergone PCI within the preceding 30 days prior to enrollment
- Patients with known impaired renal function
- Patient is know to be pregnant or lactating
- Patients with active participation in another device or drug study
- Patients with comorbidities conferring a life expectancy of less than a year
- Patients with left bundle branch block
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
This is a prospective, open label, randomized trial of 100 patients who present to the cardiac catheterization laboratory with an ST Elevation Myocardial Infarction for primary PCI. Patients may receive up-front unfractionated heparin or low molecular weight heparin, but not glycoprotein IIb/IIIa inhibitors or thrombolytics. Patients will be consented prior to the diagnostic catheterization and will be randomized once the patient is deemed amenable to PCI to receive eptifibatide or no eptifibatide just prior to or at the time of primary angioplasty. Patients will be randomized in a 1:1 fashion. All patients will be assessed for the primary endpoint of ST resolution at 60 minutes post PCI and followed throughout the duration of the hospitalization and up to 30 days for secondary endpoint evaluation.
Read the detailed description
The aim of this study is to evaluate the effectiveness and safety of adjunctive eptifibatide during primary PCI in patients presenting to the catheterization laboratory within 12 hours of symptom onset. The primary objective of this randomized clinical trial is to examine the safety and effectiveness of the addition of eptifibatide therapy immediately prior to or at the time of PCI in patients presenting with a STEMI for primary PCI who have not received up-front glycoprotein IIb/IIIa inhibitor therapy. The secondary objective of this clinical trial is to assess effectiveness of adjunct eptifibatide therapy with respect to the following endpoints:
- Complete ST resolution (defined above) at 90 and 180 minutes post primary PCI
- TIMI flow at the end of the PCI (as reported by the investigator at the end of the procedure)
- MACE evaluation at discharge and 30 days post PCI (MACE defined as: death, reinfarction, and need for urgent ischemia-driven target vessel revascularization)
- Stent thrombosis at discharge and 30 days
- Major Bleed (Major Bleed defined as: TIMI Major Bleeding)
- Minor Bleed (Minor Bleed defined as: TIMI Minor Bleeding)
- ST segment resolution at 60, 90 and 180 minutes based on the additional measure in the Schroder's Index:
- Partial resolution defined as 30-70% ST-segment resolution, and
- No resolution defined as <30% ST-segment resolution.
- Conditions
- Myocardial Infarction
- Being tested
- eptifibitide
- Keywords
- STEMI, Patients, male or female, greater than 18 years of age, presenting with ST elevation myocardial infarction
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eptifibitideDrug
Also called Integrilin
Patients will be randomized to eptifibatide or no eptifibatide. If randomized to eptifibatide: 180 mcg/kg Bolus; 2 mcg/kg/min infusion immediately prior to primary PCI or at the time of PCI and for 18 - 24 hours following the PCI Second 180 mcg/kg Bolus 10 min after the first
| Study group | Role | What they receive |
|---|---|---|
| Eptifibatide | Experimental | PCI with administration of eptifibatide Receives: Drug: eptifibitide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be complete ST resolution 60 minutes following primary PCI where complete ST resolution is defined as ≥70% ST resolution compared to the qualifying ECG.
Measured: In patient hopsitalization
Secondary outcomes (1)
Complete ST resolution (defined above) at 90 and 180 minutes following primary PCI; TIMI flow at the end of the PCI; and MACE evaluation at discharge and 30 days post PCI
Measured: In-patient hospitalization and 30 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startAug 2007
- Primary completionJul 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ron Waksman, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812435
- Sponsor's protocol ID
- ESTEEM
- Acronym
- ESTEEM
- Status last verified
- Aug 2014
- First submitted
- 17 Feb 2008
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eptifibatide and ST Segment Resolution Following Primary PCI
- ClinicalTrials.gov ID
- NCT00812435
- Acronym / sponsor ID
- ESTEEM / ESTEEM
- Conditions
- Myocardial Infarction
- Keywords
- STEMI, Patients, male or female, greater than 18 years of age, presenting with ST elevation myocardial infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 22 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, open label, randomized trial of 100 patients who present to the cardiac catheterization laboratory with an ST Elevation Myocardial Infarction for primary PCI. Patients may receive up-front unfractionated heparin or low molecular weight heparin, but not glycoprotein IIb/IIIa inhibitors or thrombolytics. Patients will be consented prior to the diagnostic catheterization and will be randomized once the patient is deemed amenable to PCI to receive eptifibatide or no eptifibatide just prior to or at the time of primary angioplasty. Patients will be randomized in a 1:1 fashion. All patients will be assessed for the primary endpoint of ST resolution at 60 minutes post PCI and followed throughout the duration of the hospitalization and up to 30 days for secondary endpoint evaluation.
Detailed description
The aim of this study is to evaluate the effectiveness and safety of adjunctive eptifibatide during primary PCI in patients presenting to the catheterization laboratory within 12 hours of symptom onset. The primary objective of this randomized clinical trial is to examine the safety and effectiveness of the addition of eptifibatide therapy immediately prior to or at the time of PCI in patients presenting with a STEMI for primary PCI who have not received up-front glycoprotein IIb/IIIa inhibitor therapy. The secondary objective of this clinical trial is to assess effectiveness of adjunct eptifibatide therapy with respect to the following endpoints:
- Complete ST resolution (defined above) at 90 and 180 minutes post primary PCI
- TIMI flow at the end of the PCI (as reported by the investigator at the end of the procedure)
- MACE evaluation at discharge and 30 days post PCI (MACE defined as: death, reinfarction, and need for urgent ischemia-driven target vessel revascularization)
- Stent thrombosis at discharge and 30 days
- Major Bleed (Major Bleed defined as: TIMI Major Bleeding)
- Minor Bleed (Minor Bleed defined as: TIMI Minor Bleeding)
- ST segment resolution at 60, 90 and 180 minutes based on the additional measure in the Schroder's Index:
- Partial resolution defined as 30-70% ST-segment resolution, and
- No resolution defined as <30% ST-segment resolution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eptifibatide | Experimental | Drug: eptifibitidePCI with administration of eptifibatide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients >18 years old
- Patients with acute myocardial infarction whose symptom onset is within 12 hours of presentation
- ST-segment elevation 1 mm in 2 contiguous limb leads or 2 mm in 2 contiguous precordial leads
- Patients eligible for PCI
- Target lesion(s) in a native vessel
Key exclusion criteria (17 listed)
- Patients with cardiogenic shock (SBP<80 mmHg for >30 minutes or requiring pressors or IABP due to hypotension)
- Patients with cardiac arrest at any point prior to intervention (within the preceeding 24 hours)
- Patients on chronic warfarin (Coumadin) therapy
- Patients with known bleeding diathesis or active bleeding at the time of presentation to the catheterization laboratory
- Patients with known bleeding diathesis or active bleeding within prior 3 months
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 |
|---|---|---|
| eptifibitideAlso: IntegrilinPatients will be randomized to eptifibatide or no eptifibatide. If randomized to eptifibatide: 180 mcg/kg Bolus; 2 mcg/kg/min infusion immediately prior to primary PCI or at the time of PCI and for 18 - 24 hours following the PCI Second 180 mcg/kg Bolus 10 min after the first | Drug | Eptifibatide |
Primary outcome
The primary endpoint will be complete ST resolution 60 minutes following primary PCI where complete ST resolution is defined as ≥70% ST resolution compared to the qualifying ECG.
Time frame: In patient hopsitalization
1 secondary outcome
Complete ST resolution (defined above) at 90 and 180 minutes following primary PCI; TIMI flow at the end of the PCI; and MACE evaluation at discharge and 30 days post PCI
Time frame: In-patient hospitalization and 30 days post discharge
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
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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.
Ron Waksman, MD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing eptifibitide in people with Myocardial Infarction, run by Medstar Health Research Institute at 1 site in United States.
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 8 inclusion and 17 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: stopped early, as of the sponsor's last update on 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was stopped early. Results are not available in the source record.
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?
The primary endpoint will be complete ST resolution 60 minutes following primary PCI where complete ST resolution is defined as ≥70% ST resolution compared to the qualifying ECG. (time frame: In patient hopsitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2014.