Combined angioplasty and pharmacological intervention versus thrombolysis alone in acute myocardial infarction (CAPITAL AMI Study)
| ISRCTN | ISRCTN44258879 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44258879 |
| Secondary identifying numbers | DCT-48205 |
- Submission date
- 05/09/2005
- Registration date
- 05/09/2005
- Last edited
- 18/04/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michel Robert Le May
Scientific
Scientific
University of Ottawa Heart Institute
40 Ruskin Street
H-150
Ottawa
K1Y4W7
Canada
| Phone | +1 613 761 4980 Or 4223 |
|---|---|
| mlemay@ottawaheart.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | CAPITAL AMI |
| Study objectives | 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 |
| Ethics approval(s) | University of Ottawa Heart Institute Human Research Ethics Board, 10/08/2000 |
| Health condition(s) or problem(s) studied | Acute myocardial infarction (AMI) |
| Intervention | Tenecteplase (TNKase) plus percutaneous coronary intervention (PCI) versus Tenecteplase (TNKase) alone |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/07/2001 |
| Completion date | 31/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 170 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2001 |
| Date of final enrolment | 31/07/2004 |
Locations
Countries of recruitment
- Canada
Study participating centre
University of Ottawa Heart Institute
Ottawa
K1Y4W7
Canada
K1Y4W7
Canada
Sponsor information
University of Ottawa Heart Institute (Canada)
Not defined
Not defined
40 Ruskin street
Ottawa
K1Y 4W7
Canada
"ROR" |
https://ror.org/03c4mmv16 |
|---|
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT-48205)
No information available
CIHR Industry-Partnered Program with Hoffmann La-Roche Limited (Canada) and Guidant Canada
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
