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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Angiomax (bivalirudin) anticoagulant
Sponsored by
The Medicines Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring ST-Segment Elevation, Acute Myocardial Infarction, PCI, Percutaneous Coronary Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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 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

Sites / Locations

  • The Heart Care Research Foundation

Outcomes

Primary Outcome Measures

Reduction in bleeding complications

Secondary Outcome Measures

Full Information

First Posted
October 4, 2004
Last Updated
February 8, 2006
Sponsor
The Medicines Company
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1. Study Identification

Unique Protocol Identification Number
NCT00093184
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Medicines Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
ST-Segment Elevation, Acute Myocardial Infarction, PCI, Percutaneous Coronary Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Angiomax (bivalirudin) anticoagulant
Primary Outcome Measure Information:
Title
Reduction in bleeding complications

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John F Stella, DO
Organizational Affiliation
Health Care Centers of Illinois
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Heart Care Research Foundation
City
Blue Island
State/Province
Illinois
ZIP/Postal Code
60406
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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