Condition category
Circulatory System
Date applied
09/09/2005
Date assigned
09/09/2005
Last edited
25/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.utoronto.ca/

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18082484

Publication citations

  1. 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.

Additional files

Editorial Notes