Status:
COMPLETED
Bivalirudin in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary PCI
Lead Sponsor:
The Medicines Company
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00093184
Start Date
April 1 2004
End Date
December 1 2005
Last Update
February 9 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Heart Care Research Foundation
Blue Island, Illinois, United States, 60406