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Trial record 1 of 4 for:    Horizons AMI
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Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00433966
First Posted: February 12, 2007
Last Update Posted: December 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Boston Scientific Corporation
The Medicines Company
Information provided by (Responsible Party):
Cardiovascular Research Foundation, New York
Results First Submitted: September 12, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Myocardial Infarction
Interventions: Drug: Bivalirudin
Drug: Unfractionated heparin
Device: Bare metal stent
Device: Paclitaxel-eluting stent

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between March 25, 2005, and May 7, 2007, 3602 patients with STEMI undergoing primary percutaneous coronary intervention were enrolled at 123 academic or community-based medical centers in 11 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Random, open-label assignment (1:1 ratio) to unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor or bivalirudin alone. After emergency angiography and triage to PCI, CABG, or GDMT, eligible patients were randomly assigned (3:1 ratio) to either paclitaxel-eluting stents or uncoated, bare-metal stents.

Reporting Groups
  Description
Pharmacology Arm - Bivalirudin

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.

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).

Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).

Pharmacology Arm - Unfractionated Heparin

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.

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).

Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).

Stent Arm - Paclitaxel-Eluting Stent

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

Bare metal stent: Uncoated bare metal stent

Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent

Stent Arm - Bare Metal Stent

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

Bare metal stent: Uncoated bare metal stent

Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent


Participant Flow for 2 periods

Period 1:   Pharmacology Intervention/Randomization
    Pharmacology Arm - Bivalirudin   Pharmacology Arm - Unfractionated Heparin   Stent Arm - Paclitaxel-Eluting Stent   Stent Arm - Bare Metal Stent
STARTED   1800   1802   0   0 
30-Day Follow-up   1787   1791   0   0 
1-Year Follow-up   1696   1702   0   0 
3-Year Follow-up   1634   1628   0   0 
COMPLETED   1634   1628   0   0 
NOT COMPLETED   166   174   0   0 
Withdrawal by Subject                40                43                0                0 
Lost to Follow-up                97                103                0                0 
Not true myocardial infarction                29                28                0                0 

Period 2:   Stent Intervention/Randomization
    Pharmacology Arm - Bivalirudin   Pharmacology Arm - Unfractionated Heparin   Stent Arm - Paclitaxel-Eluting Stent   Stent Arm - Bare Metal Stent
STARTED   0   0   2257   749 
1-Year Follow-up   0   0   2186   715 
3-Year Follow-up   0   0   2103   687 
COMPLETED   0   0   2103   687 
NOT COMPLETED   0   0   154   62 
Withdrawal by Subject                0                0                41                15 
Lost to Follow-up                0                0                113                47 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline data is presented by first randomization (pharmacology).

Reporting Groups
  Description
Pharmacology Arm - Bivalirudin

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.

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).

Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).

Pharmacology Arm - Unfractionated Heparin

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.

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).

Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room).

Total Total of all reporting groups

Baseline Measures
   Pharmacology Arm - Bivalirudin   Pharmacology Arm - Unfractionated Heparin   Total 
Overall Participants Analyzed 
[Units: Participants]
 1800   1802   3602 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 59.8 
 (51.9 to 69.5) 
 60.7 
 (52.9 to 70.1) 
 60.2 
 (52.4 to 69.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      412  22.9%      430  23.9%      842  23.4% 
Male      1388  77.1%      1372  76.1%      2760  76.6% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events   [ Time Frame: 30 Days ]

2.  Primary:   Stent Arm - Ischemic Target Lesion Revascularization   [ Time Frame: 1 year ]

3.  Primary:   Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis   [ Time Frame: 1 year ]

4.  Secondary:   Pharmacology Arm - Major Adverse Cardiovascular Events   [ Time Frame: 30 days ]

5.  Secondary:   Pharmacology Arm - Non-Coronary Artery Bypass Grafting-Related Major Bleeding   [ Time Frame: 30 days ]

6.  Secondary:   Stent Arm - Segment Binary Angiographic Restenosis   [ Time Frame: 13 months ]

7.  Secondary:   Pharmacology Arm - Major Adverse Cardiovascular Events   [ Time Frame: 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ori Ben-Yehuda, MD, Executive Director, Clinical Trials Center
Organization: Cardiovascular Research Foundation
phone: 646-434-4123
e-mail: obenyehuda@crf.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Cardiovascular Research Foundation, New York
ClinicalTrials.gov Identifier: NCT00433966     History of Changes
Other Study ID Numbers: HORIZONS AMI
First Submitted: February 9, 2007
First Posted: February 12, 2007
Results First Submitted: September 12, 2017
Results First Posted: December 4, 2017
Last Update Posted: December 4, 2017