Myocardial InfarctionPhase 3NCT00093184
Bivalirudin in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary PCI
A Phase 3 study testing Angiomax (bivalirudin) anticoagulant in people with Myocardial Infarction, run by The Medicines Company at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the benefit of bivalirudin in combination with clopidogrel with provisional GPIIb/IIIa inhibitor use, in reducing the bleeding complications associated with early invasive management of patients presenting with an ST Elevation Myocardial Infarction (STEMI) and undergoing… 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?
- Angiomax (bivalirudin) anticoagulant
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Dec 2005
- 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 of age.
- Symptoms of STEMI for at least 30 min within previous 12 hours AND
- ST-segment elevation in at least 2 contiguous leads or new Left Branch Bundle Block (LBBB), OR existing LBBB with positive troponin
- Residual high grade stenosis and associated abnormalities in regional wall motion.
- Planned primary PCI in native coronary vessel.
Who cannot join
- Confirmed pregnancy
- Fibrinolytic therapy - Any alteplase, reteplase, tenectoplase, or streptokinase within the last 24 hours
- Culprit lesion within SVG or bypass conduit
- Dependency on renal dialysis
- Administration of LMWH within 8 hours prior to PCI
- Administration of abciximab within 7 days prior to PCI
Show all 20Show fewer
- Administration of eptifibatide or tirofiban within 12 hours prior to PCI
- Warfarin MUST BE discontinued prior to procedure, and the INR must be ⎕1.5, or the PT<15,
- Heparin. If heparin is administered in the ER as long as it is discontinued at least 30 minutes prior to procedure, OR ACT <250, a patient may be enrolled. No clotting measurements are required if patient received heparin ⎕30 minutes prior to the initiation of bivalirudin.
- Allergy to heparin or bivalirudin, or known sensitivity to any component of the products
- Allergy to aspirin, clopidogrel, or abciximab
- Contraindication to abciximab
- Angiomax within 24 hours prior to study drug administration
- Neurosurgery with three months
- Severe hypertension not adequately controlled by antihypertensive therapy at the time of study entry (BP >180/110 mm Hg)
- Cardiogenic shock (SBP <80 for >30 min or a need for intravenous pressors)
- Stroke within three months
- Any hemorrhagic diathesis
- Life expectancy <1 year
- Participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
The Heart Care Research Foundation
Blue Island, Illinois, 60406
About this study
Official title: A Study Evaluating the Safety and Efficacy of Bivalirudin in the Management of Patients With ST-Segment Elevation Acute Myocardial Infarction Undergoing Primary PCI (BIAMI)
The purpose of this study is to demonstrate the benefit of bivalirudin in combination with clopidogrel with provisional GPIIb/IIIa inhibitor use, in reducing the bleeding complications associated with early invasive management of patients presenting with an ST Elevation Myocardial Infarction (STEMI) and undergoing primary PCI, while providing similar rates of ischemic events when compared to published results of relevant trials.
- Conditions
- Myocardial Infarction
- Being tested
- Angiomax (bivalirudin) anticoagulant
- Keywords
- ST-Segment Elevation, Acute Myocardial Infarction, PCI, Percutaneous Coronary Intervention
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiomax (bivalirudin) anticoagulantDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in bleeding complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2004 (estimated)
- Study startApr 2004
- Study completionDec 2005
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- The Medicines Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John F Stella, DO, Principal investigator, Health Care Centers of Illinois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093184
- Sponsor's protocol ID
- TMC-BIV-04-01
- Status last verified
- Feb 2006
- First submitted
- 4 Oct 2004
- Last updated
- 9 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Safety and Efficacy of Bivalirudin in the Management of Patients With ST-Segment Elevation Acute Myocardial Infarction Undergoing Primary PCI (BIAMI)
- ClinicalTrials.gov ID
- NCT00093184
- Acronym / sponsor ID
- TMC-BIV-04-01
- Conditions
- Myocardial Infarction
- Keywords
- ST-Segment Elevation, Acute Myocardial Infarction, PCI, Percutaneous Coronary Intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Dec 2005
- First posted
- 7 Oct 2004 (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.
The purpose of this study is to demonstrate the benefit of bivalirudin in combination with clopidogrel with provisional GPIIb/IIIa inhibitor use, in reducing the bleeding complications associated with early invasive management of patients presenting with an ST Elevation Myocardial Infarction (STEMI) and undergoing primary PCI, while providing similar rates of ischemic events when compared to published results of relevant trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients >18 years of age.
- Symptoms of STEMI for at least 30 min within previous 12 hours AND
- Planned primary PCI in native coronary vessel.
Key exclusion criteria (20 listed)
- Confirmed pregnancy
- Fibrinolytic therapy - Any alteplase, reteplase, tenectoplase, or streptokinase within the last 24 hours
- Culprit lesion within SVG or bypass conduit
- Dependency on renal dialysis
- Administration of LMWH within 8 hours prior to PCI
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 |
|---|---|---|
| Angiomax (bivalirudin) anticoagulant | Drug | – |
Primary outcome
Reduction in bleeding complications
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 9 Feb 2006.
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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.
John F Stella, DO principal investigator
Health Care Centers of Illinois
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 Angiomax (bivalirudin) anticoagulant in people with Myocardial Infarction, run by The Medicines Company 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 5 inclusion and 20 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 9 Feb 2006. 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 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?
Reduction in bleeding complications. 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 9 Feb 2006.