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| [ ...Back to search results ] | [ Print-friendly version ] |
| Combined angioplasty and pharmacological intervention versus thrombolysis alone in acute myocardial infarction (CAPITAL AMI Study) |
| ISRCTN | ISRCTN44258879 |
| ClinicalTrials.gov identifier | |
| Public title | Combined angioplasty and pharmacological intervention versus thrombolysis alone in acute myocardial infarction (CAPITAL AMI Study) |
| Scientific title | |
| Acronym | CAPITAL AMI |
| Serial number at source | DCT-48205 |
| Study hypothesis | To assess the effectiveness of a strategy combining thrombolysis followed by immediate angiography with intentional stenting of the IRA, compared with thrombolysis alone, for the treatment of high risk AMI patients |
| Lay summary | |
| Ethics approval | University of Ottawa Heart Institute Human Research Ethics Board, 10/08/2000 |
| Study design | Randomised controlled trial |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Acute myocardial infarction (AMI) |
| Participants - inclusion criteria |
1. Ischemic chest discomfort of ≥30 minutes duration
2. Aged 18 years and older, either sex 3. Onset of Chest Pain ≤6 hours prior to entry into the study and one of the following high risk criteria: 3.1. Anterior AMI with ST-segment elevation ≥2 mm in each of at least contiguous precordial leads (V1-V6) 3.2. Extensive nonanterior AMI on a standard 12 lead electrocardiogram (ECG) defined as: 3.2.1. Eight or more leads with ≥0.1 mV ST elevation or depression, or both; ST segment elevation of >1 mm (0.1 mV) must be present in two or more contiguous electrocardiographic leads 3.2.2. Sum of ST-segment elevation >20 mm measured 60 msec after the J-point 4. Killip 3 and either ST segment elevation of >1 mm (0.1 mV) in two or more contiguous electrocardiographic leads (on a standard 12 lead ECG) or left bundle branch block not known to be old 5. Systolic blood pressure <100 mmHg and either ST segment elevation of >1 mm (0.1mV) in two or more contiguous electrocardiographic leads (on a standard 12 lead ECG) or left bundle branch block not known to be old |
| Participants - exclusion criteria |
1. Low risk AMI defined as having the absence of high risk features defined above
2. Acute bleeding 3. History of stroke or central nervous system (CNS) damage 4. Major surgery or trauma within the past 3 months 5. Uncontrolled hypertension (SBP ≥200 mmHg and/or DBP ≥120 mmHg despite treatment) 6. Prolonged (>10 min) cardiopulmonary resuscitation 7. Inadequate vascular access 8. Previous coronary artery bypass graft (CABG) 9. PTCA within the last 6 months 10. Abciximab (ReoPro TM) or other GP IIb/IIIa antagonists within the preceding 7 days 11. Coagulation disorder (i.e. international normalized ratio (INR) >2.0, platelets <100,000/mm^3, or hematocrit <30% 12. Current warfarin treatment 13. Within 6 hours randomization, either: a. Standard unfractionated heparin (heparin sodium) ≥5000 IU b. A subcutaneous therapeutic dose of any low molecular weight heparin 14. Intolerance to aspirin 15. Other medical condition that is likely to result in death within 12 months 16. Participation in a study with another investigational device or drug <4 weeks 17. Pregnancy 18. Known severe renal impairment (creatinine >300 µmol/l 19. Sustained hypotension defined as SBP <90 mmHg or the need for intravenous (IV) inotropes and/or intraaortic balloon counter pulsation to support the blood pressure 20. Known severe contrast (dye) allergy 21. Inability to provide informed consent |
| Anticipated start date | 01/07/2001 |
| Anticipated end date | 31/07/2004 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 170 |
| Interventions | Tenecteplase (TNKase) plus percutaneous coronary intervention (PCI) versus Tenecteplase (TNKase) alone |
| Primary outcome measure(s) |
The primary end point will be the composite of the following clinical events:
1. Death 2. Recurrent myocardial infraction 3. Recurrent unstable ischemia 4. Stroke, measured at 6 months after the index AMI |
| Secondary outcome measure(s) |
Determine if combined pharmacological and interventional strategy compared to pharmacological alone:
1. Decreases the frequency of the following individual clinical events: a. Death b. Recurrent myocardial infarction c. Recurrent unstable ischemia d. Stroke 2. Improves ST-segment elevation resolution, a surrogate marker of clinical efficacy 3. Decreases the need for subsequent revascularization (PTCA of the target vessel, PTCA of a non-target vessel, or CABG) 4. Decreases the frequency of recurrent unstable ischemia 5. Decreases the frequency of CHF and cardiogenic shock 6. Decreases the frequency of CHF at follow-up 7. Improves CCS angina class at follow-up 8. Is economically attractive 9. Influences subsequent quality of life 10. Is feasible in community hospitals without an on-site catheterization laboratory i.e. patients with large AMI who are initially treated with thrombolytic therapy can be transferred safely and in a timely fashion to a centre equipped with a catheterization laboratory for interventional therapy |
| Sources of funding |
1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT-48205)
CIHR Industry-Partnered Program with Hoffmann La-Roche Limited (Canada) and Guidant Canada |
| Trial website | |
| Publications | |
| Contact name | Dr Michel Robert Le May |
| Address |
University of Ottawa Heart Institute
40 Ruskin Street H-150 |
| City/town | Ottawa |
| Zip/Postcode | K1Y4W7 |
| Country | Canada |
| Tel | +1 613 761 4980 Or 4223 |
| Fax | +1 613 761 4358 |
| mlemay@ottawaheart.ca | |
| Sponsor | University of Ottawa Heart Institute (Canada) |
| Address | 40 Ruskin street |
| City/town | Ottawa |
| Zip/Postcode | K1Y 4W7 |
| Country | Canada |
| Date applied | 05/09/2005 |
| Last edited | 18/04/2008 |
| Date ISRCTN assigned | 05/09/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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