Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction

November 30, 2017 updated by: Cardiovascular Research Foundation, New York

Dual Arm Factorial Randomized Trial in Patients w/ST Segment Elevation AMI to Compare the Results of Using Anticoagulation With Either Unfractionated Heparin + Routine GP IIb/IIIa Inhibition or Bivalirudin + Bail-out GP IIb/IIIa Inhibition; and Primary Angioplasty With Stent Implantation With Either a Slow Rate-release Paclitaxel-eluting Stent (TAXUS™) or Uncoated Bare Metal Stent (EXPRESS2™)

The primary objectives of the trial are:

  1. To establish the safety and efficacy of the use of bivalirudin (+ bail-out GP IIb/IIIa inhibitors) compared to the use of unfractionated heparin + GP IIb/IIIa inhibitors in patients with acute myocardial infarction undergoing a primary angioplasty strategy.
  2. To establish the safety and efficacy of the slow rate release paclitaxel-eluting TAXUS™ stent compared to an otherwise identical uncoated bare metal EXPRESS2™ stent.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective, 2 x 2 factorial single blind, randomized, multi-center trial of 3400 patients enrolled at up to 200 centers. Patients will be randomized 1:1 in the emergency room to a) anticoagulation with unfractionated heparin plus routine GP IIb/IIIa inhibition vs. b) bivalirudin and bail-out GP IIb/IIIa inhibition. Following angiography, patients with lesions eligible for stenting will then undergo a second randomization (3:1) to stent implantation with either a) a slow rate-release paclitaxel-eluting stent (TAXUS™) or b) an otherwise identical uncoated bare metal stent (EXPRESS2™).

Study Type

Interventional

Enrollment (Actual)

3602

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • LeBauer CV Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have clinical symptoms consistent with AMI (e.g., angina or anginal equivalent)lasting >20 minutes but <12 hours in duration;
  • ST-segment elevation of >1 mm in >2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >1 mm in >2 contiguous anterior leads;
  • The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent.

Exclusion Criteria:

  • The patient has a known hypersensitivity or contraindication to any of the following medications:

    • Heparin, pork or pork products
    • Both abciximab and eptifibatide
    • Aspirin
    • Both Clopidogrel and Ticlopidine
    • Bivalirudin
    • Paclitaxel or Taxol
    • The polymer components of the TAXUS™ stent (SIBS)
    • Stainless steel and/or
    • Contrast media;
  • Prior administration of thrombolytic therapy, bivalirudin, GP IIb/IIIa inhibitors, low molecular weight heparin or fondaparinux for this admission. Patients receiving prior unfractionated heparin may be enrolled, and treated per randomization;
  • Current use of coumadin;
  • Systemic (intravenous) Paclitaxel or Taxol use within 12 months;
  • Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrollment into this study;
  • History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;
  • History of intra-cerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke;
  • Stroke or transient ischemic attack within the past 6 months, or any permanent residual neurologic defect;
  • Gastrointestinal or genitourinary bleeding within the last 2 months, or major surgery within six weeks;
  • Recent history or known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL;
  • Extensive peripheral vascular disease, such that emergent angiography and intervention in the opinion of the investigator is likely to be difficult or complicated;
  • An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first six months post enrollment;
  • Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance;
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
  • Previous enrollment in this trial;
  • Patients who underwent coronary stent implantation within the past 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pharmacology Arm

To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:

  1. reduced rates of major bleeding events at 30 days
  2. similar rates of major adverse ischemic cardiac events at 30 days
  3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.
Drug: Bivalirudin
Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).
Other Names:
  • Angiomax
Drug: Unfractionated heparin
60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).
Other Names:
  • Heparin Sodium
Active Comparator: Stent Arm

To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:

  1. reduced rates of target lesion revascularization for ischemia at 1 year
  2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year
  3. lower rates of analysis segment binary angiographic restenosis at 13 months
Device: Bare metal stent
Uncoated bare metal stent
Other Names:
  • EXPRESS2™
Device: Paclitaxel-eluting stent
slow rate-release paclitaxel-eluting stent
Other Names:
  • TAXUS™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events
Time Frame: 30 Days
Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke) and major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting).
30 Days
Stent Arm - Ischemic Target Lesion Revascularization
Time Frame: 1 year
Number of Participants With Ischemic Target Lesion Revascularization
1 year
Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis
Time Frame: 1 year
Number of Participants With Death, Reinfarction, Stroke, or Stent Thrombosis
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacology Arm - Major Adverse Cardiovascular Events
Time Frame: 30 days
Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke)
30 days
Pharmacology Arm - Non-Coronary Artery Bypass Grafting-Related Major Bleeding
Time Frame: 30 days
Number of participants with major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting)
30 days
Stent Arm - Segment Binary Angiographic Restenosis
Time Frame: 13 months
Number of Participants With Segment Binary Angiographic Restenosis (13-month Angiographic Subset).
13 months
Pharmacology Arm - Major Adverse Cardiovascular Events
Time Frame: 3 years
Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiovascular Research Foundation, New York

Collaborators

Boston Scientific Corporation
The Medicines Company

Investigators

  • Study Director: Roxana Mehran, MD, CardioVascular Research Foundation
  • Principal Investigator: Gregg W Stone, MD, CardioVascular Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

February 9, 2007

First Submitted That Met QC Criteria

February 9, 2007

First Posted (Estimate)

February 12, 2007

Study Record Updates

Last Update Posted (Actual)

December 4, 2017

Last Update Submitted That Met QC Criteria

November 30, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HORIZONS AMI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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