Clinical trial NCT00433966: Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction
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™)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Keywords: Myocardial Infarction
Angioplasty
Myocardial Ischemia
Myocardial Reperfusion
Stents
Heart Disease
Lead sponsor: Cardiovascular Research Foundation, New York
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
name: The Medicines Company
First posted: 2007-02-12
Enrollment: 3602
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

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™).

Eligibility 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.

Primary outcomes:
measure: Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events
timeFrame: 30 Days
measure: Stent Arm - Ischemic Target Lesion Revascularization
timeFrame: 1 year
measure: Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis
timeFrame: 1 year
Secondary outcomes:
measure: Pharmacology Arm - Major Adverse Cardiovascular Events
timeFrame: 30 days
measure: Pharmacology Arm - Non-Coronary Artery Bypass Grafting-Related Major Bleeding
timeFrame: 30 days
measure: Stent Arm - Segment Binary Angiographic Restenosis
timeFrame: 13 months
measure: Pharmacology Arm - Major Adverse Cardiovascular Events
timeFrame: 3 years
Other outcomes:
Locations:
city: Greensboro
country: United States
facility: LeBauer CV Research Foundation
state: North Carolina
Study officials:
affiliation: CardioVascular Research Foundation
name: Gregg W Stone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CardioVascular Research Foundation
name: Roxana Mehran, MD
role: STUDY_DIRECTOR
References:
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citation: Brener SJ, Dizon JM, Mehran R, Guerchicoff A, Lansky AJ, Farkouh M, Brodie B, Guagliumi G, Witzenbichler B, Fahy M, Parise H, Stone GW. Complementary prognostic utility of myocardial blush grade and ST-segment resolution after primary percutaneous coronary intervention: analysis from the HORIZONS-AMI trial. Am Heart J. 2013 Oct;166(4):676-83. doi: 10.1016/j.ahj.2013.07.025. Epub 2013 Sep 13.
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