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

This study has been completed.
Sponsor:
Information provided by:
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00093184
First received: October 4, 2004
Last updated: February 8, 2006
Last verified: February 2006
  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.


Condition Intervention Phase
Myocardial Infarction
Drug: Angiomax (bivalirudin) anticoagulant
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by The Medicines Company:

Primary Outcome Measures:
  • Reduction in bleeding complications

Estimated Enrollment: 300
Study Start Date: April 2004
Estimated Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093184

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

No publications provided

ClinicalTrials.gov Identifier: NCT00093184     History of Changes
Other Study ID Numbers: TMC-BIV-04-01
Study First Received: October 4, 2004
Last Updated: February 8, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by The Medicines Company:
ST-Segment Elevation
Acute Myocardial Infarction
PCI
Percutaneous Coronary Intervention

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Bivalirudin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014