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

Completed

• Conditions: Acute Myocardial Infarction; Circulatory System

• Registration Number: ISRCTN04467549
• Lead Sponsor: niversity of Toronto (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-09
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1158

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified