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

NCT00093184 | Completed Phase 3

• 1 other identifier: TMC-BIV-04-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

ST-Segment Elevation; Acute Myocardial Infarction; PCI; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Reduction in bleeding complications

Interventions

Angiomax (bivalirudin) anticoagulant DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Medicines Company: lead

Study Sites (1)

The Heart Care Research Foundation

Blue Island, Illinois, 60406, United States

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

bivalirudin; Anticoagulants

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• John F Stella, DO

  Health Care Centers of Illinois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 4, 2004
• First Posted: October 7, 2004
• Study Start: April 1, 2004
• Study Completion: December 1, 2005
• Last Updated: February 9, 2006

Record last verified: 2006-02

Locations

US (1)