Expired Study
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Blue Island, Illinois 60406


Purpose:

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.


Criteria:

Inclusion Criteria: 1. Patients >18 years of age. 2. 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. 3. Planned primary PCI in native coronary vessel. Exclusion Criteria: 1. Confirmed pregnancy 2. Fibrinolytic therapy - Any alteplase, reteplase, tenectoplase, or streptokinase within the last 24 hours 3. Culprit lesion within SVG or bypass conduit 4. Dependency on renal dialysis 5. Administration of LMWH within 8 hours prior to PCI 6. Administration of abciximab within 7 days prior to PCI 7. Administration of eptifibatide or tirofiban within 12 hours prior to PCI 8. Warfarin MUST BE discontinued prior to procedure, and the INR must be ⎕1.5, or the PT<15, 9. 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. 10. Allergy to heparin or bivalirudin, or known sensitivity to any component of the products 11. Allergy to aspirin, clopidogrel, or abciximab 12. Contraindication to abciximab 13. Angiomax within 24 hours prior to study drug administration 14. Neurosurgery with three months 15. Severe hypertension not adequately controlled by antihypertensive therapy at the time of study entry (BP >180/110 mm Hg) 16. Cardiogenic shock (SBP <80 for >30 min or a need for intravenous pressors) 17. Stroke within three months 18. Any hemorrhagic diathesis 19. Life expectancy <1 year 20. Participation in another clinical trial


Study is Available At:


Original ID:

TMC-BIV-04-01


NCT ID:

NCT00093184


Secondary ID:


Study Acronym:


Brief Title:

Bivalirudin in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary PCI


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)


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The Medicines Company


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

300


Enrollment Type:


Overall Contact Information

Official Name:John F Stella, DO
Principal Investigator
Health Care Centers of Illinois

Study Dates

Start Date:April 2004
Completion Date:December 2005
Verification Date:February 2006
Last Changed Date:February 8, 2006
First Received Date:October 4, 2004

Study Outcomes

Outcome Type:Primary Outcome
Measure:Reduction in bleeding complications
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Angiomax (bivalirudin) anticoagulant

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:The Medicines Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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