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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00093184
Recruitment Status : Completed
First Posted : October 7, 2004
Last Update Posted : February 9, 2006
Information provided by:
The Medicines Company

Brief 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 primary PCI, while providing similar rates of ischemic events when compared to published results of relevant trials.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Angiomax (bivalirudin) anticoagulant Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : April 2004
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Bivalirudin

Primary Outcome Measures :
  1. Reduction in bleeding complications

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00093184

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United States, Illinois
The Heart Care Research Foundation
Blue Island, Illinois, United States, 60406
Sponsors and Collaborators
The Medicines Company
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Principal Investigator: John F Stella, DO Health Care Centers of Illinois

Layout table for additonal information Identifier: NCT00093184    
Other Study ID Numbers: TMC-BIV-04-01
First Posted: October 7, 2004    Key Record Dates
Last Update Posted: February 9, 2006
Last Verified: February 2006
Keywords provided by The Medicines Company:
ST-Segment Elevation
Acute Myocardial Infarction
Percutaneous Coronary Intervention
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents