Contact information
Type
Scientific
Primary contact
Dr Warren Joseph Cantor
ORCID ID
Contact details
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
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00164190
Protocol/serial number
MCT-69798
Study information
Scientific title
Routine angioplasty and stenting after fibrinolysis to enhance reperfusion in acute myocardial infarction: a randomised controlled trial
Acronym
TRANSFER-AMI
Study 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 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
St Michael's Hospital (Toronto) - Research Ethics Board Office of Research Administration approved on 21st July 2003
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Acute Myocardial Infarction
Intervention
1. 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 type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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
Secondary outcome measures
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
Overall trial start date
07/10/2004
Overall trial end date
31/08/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1158 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1158
Participant exclusion criteria
1. 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
Recruitment start date
07/10/2004
Recruitment end date
31/08/2007
Locations
Countries of recruitment
Canada
Trial participating centre
Interventional Cardiologist, Southlake Regional Health Centre
Newmarket, Ontario
L3Y 2R2
Canada
Sponsor information
Organisation
University of Toronto (Canada)
Sponsor details
27 King's College Circle
Toronto
M5S 1A1
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-69798)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18082484
Publication citations
-
Results
Cantor WJ, Fitchett D, Borgundvaag B, Heffernan M, Cohen EA, Morrison LJ, Ducas J, Langer A, Mehta S, Lazzam C, Schwartz B, Dzavik V, Goodman SG, Rationale and design of the Trial of Routine ANgioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI)., Am. Heart J., 2008, 155, 1, 19-25, doi: 10.1016/j.ahj.2007.08.025.