Bivalirudin in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary PCI
NCT ID: NCT00093184
Last Updated: 2006-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2004-04-30
2005-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Angiomax (bivalirudin) anticoagulant
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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The Medicines Company
INDUSTRY
Principal Investigators
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John F Stella, DO
Role: PRINCIPAL_INVESTIGATOR
Health Care Centers of Illinois
Locations
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The Heart Care Research Foundation
Blue Island, Illinois, United States
Countries
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Other Identifiers
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TMC-BIV-04-01
Identifier Type: -
Identifier Source: org_study_id