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

Myocardial Infarction Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00093184
• Other study ID #: TMC-BIV-04-01
• Status: Completed
• Phase: Phase 3
• First received: October 4, 2004
• Last updated: February 8, 2006
• Start date: April 2004
• Est. completion date: December 2005

Study information

• Verified date: February 2006
• Source: The Medicines Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Angiomax (bivalirudin) anticoagulant

Locations

Country	Name	City	State
United States	The Heart Care Research Foundation	Blue Island	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
The Medicines Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in bleeding complications