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

Sponsor

The Medicines Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00093184

Collaborator

(none)

300

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Drug: Angiomax (bivalirudin) anticoagulant	Phase 3

Study Design

Study Type:

Interventional

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 :

Apr 1, 2004

Study Completion Date :

Dec 1, 2005

Outcome Measures

Primary Outcome Measures

Reduction in bleeding complications []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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