Condition category
Circulatory System
Date applied
05/09/2005
Date assigned
05/09/2005
Last edited
18/04/2008
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 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

Sponsor information

Organisation

University of Ottawa Heart Institute (Canada)

Sponsor details

40 Ruskin street
Ottawa
K1Y 4W7
Canada

Sponsor type

Not defined

Website

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

Publication citations

Additional files

Editorial Notes