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Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Cardiovascular Research Foundation, New York
Boston Scientific Corporation
The Medicines Company
Information provided by: Cardiovascular Research Foundation, New York
ClinicalTrials.gov Identifier: NCT00433966
  Purpose

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.

Condition Intervention Phase
Myocardial Infarction
Drug: Bivalirudin
Drug: Unfractionated heparin
Device: Uncoated bare metal stent (EXPRESS2™)
Device: Paclitaxel-eluting stent (TAXUS™)
Phase III

MedlinePlus related topics: Angioplasty Blood Thinners Heart Attack
Drug Information available for: Paclitaxel Heparin Bivalirudin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title: 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™)

Further study details as provided by Cardiovascular Research Foundation, New York:

Primary Outcome Measures:
  • Composite of major adverse ischemic cardiac events + major bleeding at 30 days
  • Ischemic target lesion revascularization at 1 year
  • Composite rate of death, reinfarction, stroke or stent thrombosis at 1 year

Secondary Outcome Measures:
  • Major bleeding events at 30 days
  • Major adverse ischemic cardiac events at 30 days
  • Analysis segment binary angiographic restenosis at 13 months

Estimated Enrollment: 3400
Study Start Date: March 2005
Estimated Study Completion Date: May 2011
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433966

Locations
United States, North Carolina
LeBauer CV Research Foundation
Greensboro, North Carolina, United States, 27401
Sponsors and Collaborators
Cardiovascular Research Foundation, New York
Boston Scientific Corporation
The Medicines Company
Investigators
Principal Investigator: Gregg W Stone, MD CardioVascular Research Foundation, Korea
Study Director: Roxana Mehran, MD CardioVascular Research Foundation, Korea
  More Information

Publications indexed to this study:
Study ID Numbers: HORIZONS AMI
Study First Received: February 9, 2007
Last Updated: May 21, 2007
ClinicalTrials.gov Identifier: NCT00433966  
Health Authority: United States: Food and Drug Administration

Keywords provided by Cardiovascular Research Foundation, New York:
Myocardial Infarction
Angioplasty
Myocardial Ischemia
Myocardial Reperfusion
Stents
Heart Disease

Study placed in the following topic categories:
Heart Diseases
Myocardial Ischemia
Heparin, Low-Molecular-Weight
Vascular Diseases
Ischemia
Calcium heparin
Necrosis
Paclitaxel
Bivalirudin
Emergencies
Infarction
Myocardial Infarction
Heparin

Additional relevant MeSH terms:
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hematologic Agents
Mitosis Modulators
Fibrinolytic Agents
Cardiovascular Agents
Antimitotic Agents
Pharmacologic Actions
Fibrin Modulating Agents
Pathologic Processes
Therapeutic Uses
Tubulin Modulators
Cardiovascular Diseases
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009