Coronary Artery DiseasePhase 4NCT00111566
BRIEF-PCI: Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention
A Phase 4 study testing eptifibatide in people with Coronary Artery Disease and Myocardial Infarction, run by Cardiology Research UBC at 1 site in Canada.
Trial summary
This trial was designed to examine the efficacy of a brief versus a standard prolonged (18 hours) infusion of eptifibatide in preventing troponin I release following successful coronary stenting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction
- What is being tested?
- eptifibatide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 624 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2004to Aug 2007
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and non-pregnant female subjects
- 18 years of age or older
- Received aspirin, clopidogrel, heparin (unfractionated or low molecular weight [LMW]) and eptifibatide
- Had a successful PCI procedure with at least one stent deployed
- Availability of a hospital bed
Who cannot join
- Use of alternative anti-thrombin therapy during PCI (e.g. bivalirudin)
- High risk patients:
- Acute ST elevation MI < 48 hours (either direct PCI or rescue PCI)
- Unprotected left main PCI
- Obvious large thrombus on angiography
- Use of rotablation, atherectomy, or thrombectomy devices
Show all 23Show fewer
- Unsatisfactory PCI results:
- Final thrombolysis in myocardial infarction (TIMI) flow < 3
- High grade dissection (> type B, if not completely resolved at completion of PCI)
- Evident or suspected thrombus
- Distal embolization
- Suboptimal stenting (> 20% residual stenosis)
- Side branch closure (≥ 1.5 mm branch or with associated symptoms)
- Abrupt closure during procedure (if prolonged > 15 min or not resolved at completion of PCI)
- Clinical instability
- Prolonged ischemia during PCI (> 15 min)
- Increased hazard of eptifibatide infusion:
- Unsatisfactory deployment of a closure device (if used)
- Large peri-procedure hematoma making the continuation of eptifibatide hazardous
- Any condition that will increase the hazard of continuing eptifibatide
- Operator discretion
- No informed consent
- Active participation in other research studies (unless with special exemption)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention
This trial was designed to examine the efficacy of a brief versus a standard prolonged (18 hours) infusion of eptifibatide in preventing troponin I release following successful coronary stenting.
Read the detailed description
Percutaneous coronary intervention (PCI) is a common treatment for patients with severe ischemic heart disease. In the majority of cases, the potent anti-platelet agent eptifibatide is administered (bolus followed by infusion for 18 hours). The principal reason to use eptifibatide for PCI is to prevent platelet aggregation and the associated ischemia and myocardial infarction (MI). With improved laminar flow following stenting, prolonged infusion of eptifibatide may no longer be necessary. We hypothesize that after successful stenting with good angiographic results, patients can have eptifibatide discontinued immediately without a higher risk of adverse ischemic outcome, i.e. death, MI or unplanned target vessel revascularization (TVR) by 30 days. MI is defined as creatine kinase-MB (CK-MB) concentrations elevated to more than three times the upper limit of normal or new pathologic Q wave as seen on electrocardiograms (ECG). In order to prove this hypothesis, we estimate a sample size of 2,100 patients.
Before embarking on a large-scale clinical trial, we propose a pilot study using serum troponin I elevation as a surrogate end-point. Troponin I is a sensitive biomarker of ischemic injury. The absence of troponin I release following PCI would suggest excellent short and intermediate term prognosis. For the pilot study, we seek to prove the hypothesis that following successful PCI with stenting, an abbreviated regimen of eptifibatide is not inferior to the standard infusion in preventing ischemic injury, defined as troponin I release if baseline value is normal, or as CK-MB more than 3 times upper limit of normal if baseline troponin I is elevated. For this pilot study, we estimate a sample size of 620 patients.
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Being tested
- eptifibatide
- Keywords
- Percutaneous Coronary Intervention (PCI), Glycoprotein IIb/IIIa blockade, Ischemic complications following PCI
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eptifibatideDrug
| Study group | Role | What they receive |
|---|---|---|
| 18 Hour infusion | Active comparator | Not described Receives: Drug: eptifibatide |
| 4 hour infusion | Experimental | Not described Receives: Drug: eptifibatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic injury is defined as troponin I release by 24 hours when the baseline troponin I is normal or by measuring creatine kinase (CK-MB) when the baseline troponin I is elevated.
Measured: 24 Hours
Secondary outcomes (2)
30-day all-cause mortality, non-fatal myocardial infarction (MI), and unplanned target vessel revascularization (TVR)
Measured: 30 days
Composite event rate of non-coronary artery bypass graft (CABG) major bleeding, all-cause mortality, non-fatal MI, and urgent TVR at 30 days post PCI.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2005 (estimated)
- Study startDec 2004
- Primary completionJul 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 624 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiology Research UBC
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Principal investigator, Anthony Fung, MD, Cardiology Research UBC
- Investigators
- Anthony Fung, MB,BS, FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111566
- Sponsor's protocol ID
- C04-0359
- Status last verified
- Nov 2013
- First submitted
- 23 May 2005
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Saw J, Densem C, Walsh S, Jokhi P, Starovoytov A, Fox R, Wong G, Buller C, Ricci D, Mancini GB, Fung A. The effects of aspirin and clopidogrel response on myonecrosis after percutaneous coronary intervention: a BRIEF-PCI (Brief Infusion of Intravenous Eptifibatide Following Successful Percutaneous Coronary Intervention) trial substudy. JACC Cardiovasc Interv. 2008 Dec;1(6):654-9. doi: 10.1016/j.jcin.2008.08.017.
PubMed 19463380Fung AY, Saw J, Starovoytov A, Densem C, Jokhi P, Walsh SJ, Fox RS, Humphries KH, Aymong E, Ricci DR, Webb JG, Hamburger JN, Carere RG, Buller CE. Abbreviated infusion of eptifibatide after successful coronary intervention The BRIEF-PCI (Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention) randomized trial. J Am Coll Cardiol. 2009 Mar 10;53(10):837-45. doi: 10.1016/j.jacc.2008.09.060.
PubMed 19264239
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT00111566
- Acronym / sponsor ID
- C04-0359
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Keywords
- Percutaneous Coronary Intervention (PCI), Glycoprotein IIb/IIIa blockade, Ischemic complications following PCI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 624 participants (actual)
- Lead sponsor
- Cardiology Research UBCUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- Dec 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 24 May 2005 (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 trial was designed to examine the efficacy of a brief versus a standard prolonged (18 hours) infusion of eptifibatide in preventing troponin I release following successful coronary stenting.
Detailed description
Percutaneous coronary intervention (PCI) is a common treatment for patients with severe ischemic heart disease. In the majority of cases, the potent anti-platelet agent eptifibatide is administered (bolus followed by infusion for 18 hours). The principal reason to use eptifibatide for PCI is to prevent platelet aggregation and the associated ischemia and myocardial infarction (MI). With improved laminar flow following stenting, prolonged infusion of eptifibatide may no longer be necessary. We hypothesize that after successful stenting with good angiographic results, patients can have eptifibatide discontinued immediately without a higher risk of adverse ischemic outcome, i.e. death, MI or unplanned target vessel revascularization (TVR) by 30 days. MI is defined as creatine kinase-MB (CK-MB) concentrations elevated to more than three times the upper limit of normal or new pathologic Q wave as seen on electrocardiograms (ECG). In order to prove this hypothesis, we estimate a sample size of 2,100 patients.
Before embarking on a large-scale clinical trial, we propose a pilot study using serum troponin I elevation as a surrogate end-point. Troponin I is a sensitive biomarker of ischemic injury. The absence of troponin I release following PCI would suggest excellent short and intermediate term prognosis. For the pilot study, we seek to prove the hypothesis that following successful PCI with stenting, an abbreviated regimen of eptifibatide is not inferior to the standard infusion in preventing ischemic injury, defined as troponin I release if baseline value is normal, or as CK-MB more than 3 times upper limit of normal if baseline troponin I is elevated. For this pilot study, we estimate a sample size of 620 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 18 Hour infusion | Active comparator | Drug: eptifibatide |
| 4 hour infusion | Experimental | Drug: eptifibatide |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male and non-pregnant female subjects
- 18 years of age or older
- Received aspirin, clopidogrel, heparin (unfractionated or low molecular weight [LMW]) and eptifibatide
- Had a successful PCI procedure with at least one stent deployed
- Availability of a hospital bed
Key exclusion criteria (23 listed)
- Use of alternative anti-thrombin therapy during PCI (e.g. bivalirudin)
- High risk patients:
- Acute ST elevation MI < 48 hours (either direct PCI or rescue PCI)
- Unprotected left main PCI
- Obvious large thrombus on angiography
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 | Drug | 18 Hour infusion, 4 hour infusion |
Primary outcome
Ischemic injury is defined as troponin I release by 24 hours when the baseline troponin I is normal or by measuring creatine kinase (CK-MB) when the baseline troponin I is elevated.
Time frame: 24 Hours
2 secondary outcomes
30-day all-cause mortality, non-fatal myocardial infarction (MI), and unplanned target vessel revascularization (TVR)
Time frame: 30 days
Composite event rate of non-coronary artery bypass graft (CABG) major bleeding, all-cause mortality, non-fatal MI, and urgent TVR at 30 days post PCI.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
- Results publication: PubMed 19463380Saw J, Densem C, Walsh S, Jokhi P, Starovoytov A, Fox R, Wong G, Buller C, Ricci D, Mancini GB, Fung A. The effects of aspirin and clopidogrel response on myonecrosis after percutaneous coronary intervention: a BRIEF-PCI (Brief Infusion of Intravenous Eptifibatide Following Successful Percutaneous Coronary Intervention) trial substudy. JACC Cardiovasc Interv. 2008 Dec;1(6):654-9. doi: 10.1016/j.jcin.2008.08.017.
- Results publication: PubMed 19264239Fung AY, Saw J, Starovoytov A, Densem C, Jokhi P, Walsh SJ, Fox RS, Humphries KH, Aymong E, Ricci DR, Webb JG, Hamburger JN, Carere RG, Buller CE. Abbreviated infusion of eptifibatide after successful coronary intervention The BRIEF-PCI (Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention) randomized trial. J Am Coll Cardiol. 2009 Mar 10;53(10):837-45. doi: 10.1016/j.jacc.2008.09.060.
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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.
Anthony Fung, MB,BS, FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing eptifibatide in people with Coronary Artery Disease and Myocardial Infarction, run by Cardiology Research UBC at 1 site in Canada.
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 5 inclusion and 23 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 28 Nov 2013. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ischemic injury is defined as troponin I release by 24 hours when the baseline troponin I is normal or by measuring creatine kinase (CK-MB) when the baseline troponin I is elevated. (time frame: 24 Hours). 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 NCT00111566, which also lists 2 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 28 Nov 2013.