Contact information
Type
Scientific
Primary contact
Dr Michel Robert Le May
ORCID ID
Contact details
University of Ottawa Heart Institute
40 Ruskin Street
H-150
Ottawa
K1Y4W7
Canada
+1 613 761 4980 Or 4223
mlemay@ottawaheart.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DCT-48205
Study information
Scientific title
Acronym
CAPITAL AMI
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
Ethics approval
University of Ottawa Heart Institute Human Research Ethics Board, 10/08/2000
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Acute myocardial infarction (AMI)
Intervention
Tenecteplase (TNKase) plus percutaneous coronary intervention (PCI) versus Tenecteplase (TNKase) alone
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/07/2001
Overall trial end date
31/07/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
170
Participant 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
Recruitment start date
01/07/2001
Recruitment end date
31/07/2004
Locations
Countries of recruitment
Canada
Trial participating centre
University of Ottawa Heart Institute
Ottawa
K1Y4W7
Canada
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT-48205)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
CIHR Industry-Partnered Program with Hoffmann La-Roche Limited (Canada) and Guidant Canada
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