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Routine Angioplasty and Stenting After Fibrinolysis for Acute Myocardial Infarction

This study is ongoing, but not recruiting participants.
Study NCT00164190.   Last updated on May 14, 2008.   Information provided by Canadian Heart Research Centre

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Descriptive Information Fields
Brief Title  Routine Angioplasty and Stenting After Fibrinolysis for Acute Myocardial Infarction
Official Title  Trial of Routine Angioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction- The TRANSFER-AMI Trial
Brief Summary

Background:

In Canada, most patients with acute myocardial infarction (AMI) present to hospitals without cardiac catheterization facilities. Thrombolytic therapy remains the standard-of-care in these centres. However, thrombolytic therapy achieves normal coronary flow and myocardial perfusion in less than 50% of patients, and is associated with reocclusion, reinfarction, and recurrent ischemia. Primary angioplasty results in more complete reperfusion and lower rates of reocclusion, reinfarction and recurrent ischemia, but is not available in most centres. Although patients can be transferred for primary angioplasty, long transport times are associated with worse outcomes. An alternative strategy, described as facilitated angioplasty, involves administration of thrombolytic therapy at the community hospital followed by immediate transport for angioplasty. This approach achieves the benefits of primary angioplasty without delaying treatment. A well-conducted, prospective, randomized trial is needed to compare this strategy of facilitated angioplasty with standard thrombolytic therapy.

Objectives:

To evaluate the safety, feasibility, and efficacy of routine transfer of patients with AMI to an angioplasty centre immediately after thrombolysis for coronary angiography and percutaneous coronary intervention (PCI).

Hypothesis:

A strategy of routine transfer of patients with AMI to an angioplasty centre immediately after thrombolysis for coronary angiography and percutaneous intervention is associated with a significantly lower incidence of the composite of death, reinfarction, recurrent ischemia, heart failure, and shock at 30 days compared with the conventional strategy of thrombolysis with transfer reserved for failed reperfusion and/or development of shock.

Research Plan:

Patients with ST-elevation myocardial infarction and high-risk characteristics presenting to community hospitals without cardiac catheterization facilities will receive thrombolysis with tenecteplase and heparin (unfractionated or low molecular weight heparin) and will then be randomized to one of two strategies: facilitated PCI or standard treatment (thrombolysis with provisional rescue PCI). In the facilitated PCI group, patients will be transferred immediately to an angioplasty centre for urgent cardiac catheterization, and PCI if appropriate. In the standard treatment group, patients will only undergo urgent angiography for evidence of failed reperfusion and/or development of cardiogenic shock. The primary endpoint will be the composite of death, reinfarction, recurrent ischemia, heart failure, and shock at 30 days.

Detailed Description

Patients with ST-elevation myocardial infarction and high-risk characteristics presenting to community hospitals without cardiac catheterization facilities will receive thrombolysis with tenecteplase and heparin (unfractionated or low molecular weight heparin) and will then be randomized to one of two strategies: facilitated percutaneous coronary intervention (PCI) or standard treatment (thrombolysis with provisional rescue PCI). In the facilitated PCI group, patients will be transferred immediately to an angioplasty centre for urgent cardiac catheterization, and PCI if appropriate within 6 hours of thrombolysis. In the standard treatment group, patients will only undergo urgent angiography for evidence of failed reperfusion and/or development of cardiogenic shock.

Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  30-day composite of death (all cause) [ Time Frame: 30 day ] [ Designated as safety issue: No ]
Reinfarction [ Time Frame: 30 day ] [ Designated as safety issue: No ]
Recurrent ischemia [ Time Frame: 30 day ] [ Designated as safety issue: No ]
New or worsening congestive heart failure, including readmission for heart failure [ Time Frame: 30 day ] [ Designated as safety issue: No ]
Development of cardiogenic shock requiring inotropic support or intra-aortic balloon pump insertion [ Time Frame: 30 day ] [ Designated as safety issue: No ]
Secondary Outcome Measure  The incidence of major/severe bleeding, as defined by the thrombolysis in myocardial ischemia (TIMI) and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) bleeding classifications in the first 30 days [ Time Frame: 30 day ] [ Designated as safety issue: No ]
The proportion of patients with complete (> 70%) and partial (30-70%) ST-segment resolution from the qualifying electrocardiogram (ECG) to 6 hours after randomization [ Time Frame: 30 day ] [ Designated as safety issue: No ]
Infarct size as assessed by QRS scoring system on the 180 minute 12-lead electrocardiogram [ Time Frame: 30 day ] [ Designated as safety issue: No ]
The composite of death or reinfarction at 6 months [ Time Frame: 30 day ] [ Designated as safety issue: No ]
The composite of death or reinfarction at 1 year [ Time Frame: 30 day ] [ Designated as safety issue: No ]
Health costs [ Time Frame: 30 day ] [ Designated as safety issue: No ]
Condition  Myocardial Infarction
Intervention  Procedure: Routine Early Percutaneous Coronary Intervention after Thrombolysis
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  1200
Start Date  July 2004
Completion Date January 2009
Eligibility Criteria 

Inclusion Criteria:

1. Patients >= 18 years old who present within 12 hours of symptom onset with more than 30 minutes of continuous symptoms of an acute myocardial infarction to a centre that does not perform primary PCI, with either:

  • >= 2 mm ST-segment elevation in 2 or more contiguous anterior leads
  • >= 1 mm ST-segment elevation in 2 or more contiguous inferior leads with at least one of the following high-risk features:

    • Systolic blood pressure < 100 mm Hg
    • Heart rate > 100/minute
    • Killip Class II-III
    • >= 2 mm ST-segment depression in anterior leads
    • >= 1 mm ST-segment elevation in right-sided lead V4 (V4R), indicative of right ventricular involvement

Exclusion Criteria:

  1. Left bundle branch block
  2. Cardiogenic shock (Killip Class IV requiring vasopressors or inotropic support to maintain a systolic blood pressure > 90) prior to randomization
  3. Active bleeding or known hemorrhagic diathesis
  4. Availability of primary PCI with door-to-balloon time ≤ 60 minutes
  5. Time from thrombolysis to initiation of consent process > 30 minutes
  6. Use of thrombolytic agent other than tenecteplase (TNK) for index event
  7. Major surgery, biopsy of parenchymal organ, or significant trauma in the past 6 weeks
  8. Systolic blood pressure > 200 mm Hg or diastolic > 110 mm Hg after arrival to the hospital and before enrollment
  9. Concomitant use of oral anticoagulants (e.g. warfarin) with International Normalized Ratio (INR) of > 2
  10. Recent non-compressible vascular puncture
  11. History of central nervous system structural damage (e.g. aneurysm, neoplasm, arteriovenous malformation, stroke) at any time, or transient ischemic attack within the last year
  12. History of heparin-induced thrombocytopenia
  13. Documented allergy to aspirin
  14. Participation in other clinical research studies involving experimental therapies including drugs or devices within 7 days of enrollment or prior participation in this study
  15. Inability to cooperate with the protocol or undergo cardiac catheterization
  16. Other serious illness (e.g. active cancer, significant hepatic disease)
  17. Serum creatinine > 140 umol/L
  18. Percutaneous coronary intervention within one month
  19. Previous bypass surgery
  20. Pregnancy
  21. Use of enoxaparin (or other low molecular weight heparin) in last 12 hours in patient > 75 years of age
  22. Inferior ST-elevation myocardial infarction with none of the 5 high-risk features listed in the inclusion criteria
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Canada
Administrative Information Fields
NCT ID  NCT00164190
Organization ID MCT-69798
Secondary IDs †† FRN:69798
Study Sponsor  Canadian Heart Research Centre
Collaborators †† Canadian Institutes of Health Research (CIHR)
Hoffmann-La Roche
Guidant Corporation
Investigators 
Principal Investigator:     Warren J. Cantor, MD     CHRC    
Information Provided By Canadian Heart Research Centre
Verification Date May 2008
First Received Date  September 9, 2005
Last Updated Date May 14, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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