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

University of Ottawa Heart Institute
40 Ruskin Street
H-150
Ottawa
K1Y4W7
Canada

Phone +1 613 761 4980 Or 4223
Email mlemay@ottawaheart.ca

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymCAPITAL AMI
Study objectivesTo 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) studiedAcute myocardial infarction (AMI)
InterventionTenecteplase (TNKase) plus percutaneous coronary intervention (PCI) versus Tenecteplase (TNKase) alone
Intervention typeOther
Primary outcome measureThe 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 measuresDetermine 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 date01/07/2001
Completion date31/07/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants170
Key inclusion criteria1. 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 criteria1. 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 enrolment01/07/2001
Date of final enrolment31/07/2004

Locations

Countries of recruitment

  • Canada

Study participating centre

University of Ottawa Heart Institute
Ottawa
K1Y4W7
Canada

Sponsor information

University of Ottawa Heart Institute (Canada)
Not defined

40 Ruskin street
Ottawa
K1Y 4W7
Canada

ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan