Trial of routine angioplasty and stenting after fibrinolysis to enhance reperfusion in acute myocardial infarction: The TRANSFER-AMI trial

ISRCTN ISRCTN04467549
DOI https://doi.org/10.1186/ISRCTN04467549
ClinicalTrials.gov (NCT) NCT00164190
Protocol serial number MCT-69798
Sponsor University of Toronto (Canada)
Funder Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-69798)
Submission date
09/09/2005
Registration date
09/09/2005
Last edited
25/02/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Warren Joseph Cantor
Scientific

Interventional Cardiologist, Southlake Regional Health Centre
Assistant Professor of Medicine, University of Toronto
Medical Director, Interventional/Invasive Program, Southlake
641 Davis Drive
Newmarket, Ontario
L3Y 2R2
Canada

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleRoutine angioplasty and stenting after fibrinolysis to enhance reperfusion in acute myocardial infarction: a randomised controlled trial
Study acronymTRANSFER-AMI
Study objectivesA 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 ischaemia, 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.
Ethics approval(s)St Michael's Hospital (Toronto) - Research Ethics Board Office of Research Administration approved on 21st July 2003
Health condition(s) or problem(s) studiedAcute Myocardial Infarction
Intervention1. Facilitated Percutaneous Coronary Intervention (PCI) strategy: Full-dose weight-adjusted tenecteplase + unfractionated heparin or Enoxaparin (30 mg IV bolus + 1 mg/kg subcutaneously [sc]), followed by immediate transfer for cardiac catheterisation PCI
2. Thrombolysis with Provisional Rescue PCI: Full-dose weight-adjusted tenecteplase + unfractionated heparin or Enoxaparin (30 mg IV bolus + 1 mg/kg sc), bedside clinical assessment of reperfusion at 60 - 90 minutes, rescue PCI for patients with evidence of failed reperfusion
Intervention typeOther
Primary outcome measure(s)

30-day composite of:
1. Death (all cause)
2. Reinfarction
3. Recurrent ischaemia
4. New or Worsening Congestive Heart Failure, including readmission for heart failure
5. Development of cardiogenic shock requiring inotropic support or intra-aortic balloon pump insertion

Key secondary outcome measure(s)

1. The incidence of major/severe bleeding, as defined by the TIMI and GUSTO bleeding classifications in the first 30 days
2. The proportion of patients with complete (greater than 70%) and partial (30 - 70%) ST-segment resolution from the qualifying ECG to 6 hours after randomisation
3. Infarct size as assessed by QRS scoring system on the 180 minute 12-lead electrocardiogram
4. The composite of death or reinfarction at 6 months
5. The composite of death or reinfarction at 1 year
6. Health costs

Completion date31/08/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration1158
Key inclusion criteria1158 persons with acute myocardial infarction of both sex, 18 years and older. Patients greater than or equal to 18 years old who present within 12 hours of symptom onset with more than 30 minutes of continuous symptoms of an acute myocardial infarction, with high risk characteristics, defined as either:
1. 2 mm ST-segment elevation in 2 or more contiguous anterior leads
2. 1 mm ST-segment elevation in 2 or more contiguous inferior leads with either:
2.1. Systolic blood pressure less than 100 mmHg
2.2. Heart Rate greater than 100/minute
2.3. Killip Class II - III
2.4. 2 mm ST-segment depression in anterior leads
2.5. 1 mm ST-segment elevation in right-sided lead V4 (V4R), indicative of right ventricular involvement
Key exclusion criteria1. Left Bundle Branch Block
2. Cardiogenic Shock (Killip Class IV)
3. Active bleeding or known haemorrhagic diathesis
4. Availability of Primary PCI with door-to- balloon time = 60 minutes
5. Time from thrombolysis to initiation of consent process greater than 30 minutes
6. Use of thrombolytic agent other than tenecteplase for index event
7. Major surgery, biopsy of parenchymal organ, or significant trauma in the past 6 weeks
8. Systolic blood pressure greater than 200 mmHg or diastolic greater than 110 mmHg after arrival to the hospital and before enrolment
9. Concomitant use of oral anticoagulants (e.g. warfarin) with International Normalized Ratio (INR) of greater than 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 ischaemic 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 enrolment or prior participation in this study
15. Inability to cooperate with the protocol or undergo cardiac catheterisation
16. Other serious illness (e.g. active cancer, significant hepatic or renal disease)
17. Percutaneous coronary intervention within the prior month
18. Previous bypass surgery
19. Pregnancy
Date of first enrolment07/10/2004
Date of final enrolment31/08/2007

Locations

Countries of recruitment

  • Canada

Study participating centre

Interventional Cardiologist, Southlake Regional Health Centre
Newmarket, Ontario
L3Y 2R2
Canada

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2008 Yes No
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