Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257309
Status:
TERMINATED
Last Update Posted:
2017-01-19
First Post:
2005-11-18
Brief Title:
Thrombolysis Versus Primary Angioplasty for AMI in Elderly Patients
Sponsor:
Spanish Society of Cardiology
Organization:
Spanish Society of Cardiology
Study Overview
Official Title:
TRIANA A Randomized Trial to Compare the Efficay and Safety of Thrombolysis With Primary Angioplasty as Initial Reperfusion Therapy in Older Patients 75 Years Old With Acute Myocardial Infarction
Status:
TERMINATED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIANA
Brief Summary:
General objective To compare the efficacy and safety of primary angioplastyPA with that of thrombolytic therapy TT for the treatment of AMI in patients 75 years old with ST-segment elevation or LBBB AMI 6 hours of evolution without contraindications for TT
Hypothesis The therapeutical strategy based on PA is superior to that based initially on TT in patients 75 years old with AMI
Participating Centers 27 Spanish hospitals performing 50 PAyear Primary Endpoint PE Incidence of the aggregate of death of any cause reinfarction or disabling stroke at 30 days There are also 7 secondary endpoints SE
Procedure Diagnosis of inclusionexclusion criteria -- Centralized randomization -- Treatment allocation to 1 TT with weight adjusted TNK unfractionated heparin or 2 PA within 120 minutes Estimated Sample size and recruitment time 570 patients in 19 months Follow-up Blinded evaluation of events PROBE regulations specified in PE and SE at 30 days and 12 months Quality control 100 variable and follow-up review by external CRO Safety Committee and Event Adjudication Committee formed by experts not participating in the study
Hypothesis The therapeutical strategy based on PA is superior to that based initially on TT in patients 75 years old with AMI
Participating Centers 27 Spanish hospitals performing 50 PAyear Primary Endpoint PE Incidence of the aggregate of death of any cause reinfarction or disabling stroke at 30 days There are also 7 secondary endpoints SE
Procedure Diagnosis of inclusionexclusion criteria -- Centralized randomization -- Treatment allocation to 1 TT with weight adjusted TNK unfractionated heparin or 2 PA within 120 minutes Estimated Sample size and recruitment time 570 patients in 19 months Follow-up Blinded evaluation of events PROBE regulations specified in PE and SE at 30 days and 12 months Quality control 100 variable and follow-up review by external CRO Safety Committee and Event Adjudication Committee formed by experts not participating in the study
Detailed Description:
Hypothesis of the study In patients of 75 or more years of age with AMI and ST-elevation or LBBB the treatment strategy based on primary angioplasty is superior to the treatment strategy based on initial fibrinolytic therapy for reducing the incidence of death re-infarction and disabling CVA at 30 days This benefit is maintained at 12 months
Objectives General objective of the study To compare the efficacy and safety of primary angioplasty and fibrinolytic treatment in 75 year-old patients with AMI eligible for fibrinolytic therapy in Spanish medical centers with an active program of primary angioplasty
Primary end point Incidence of the combined end point of all-cause death re-infartion or disabling stroke at 30 days
Secondary end points
All-cause death at 30 days
Incidence of the combined end point of all-cause death disabling CVA or de novo heart failure at 30 days
Incidence of recurrent ischemia requiring emergency catheterization in the first 30 days
Cause of death at 30 days classified in three groups
1 Shock or heart pump failure
2 Mechanical complications ruptures or electromechanical dissociation
3 Other causes including bleeding
Incidence of major bleeding during hospital admission
All-cause mortality at 12 months
Period of time elapsed until presentation of any of the composite of all-cause death reinfarction or disabling CVA at 12 months
Period of time elapsed until the presentation of any composite of all-cause death reinfarction disabling CVA or non-elective hospital readmission for cardiac causes unstable angina heart failure non-elective coronary revascularization at 12 months
TYPE AND DESIGN OF THE CLINICAL TRIAL Clinical trial status Phase IV trial Description of randomization process The treatment strategy will be determined by a centralized randomization process using a telephone system Eligible patients will be randomized to one of two 2 treatment arms fibrinolytic treatment or primary angioplasty
Control and design This is a randomized multicenter open blind clinical trial designed to compare the efficacy and safety of primary angioplasty vs thrombolytic treatment in 75 year-old patients with AMI and ST-elevation or de novo LBBB eligible for thrombolysis admitted at Spanish medical centers that have an active primary angioplasty program within the first 6 hours after symptom onset
Masking techniques Being an open trial there are not masking techniques nor will there be an emergency opening procedure of emergency codes
Pre-inclusion clearance period Not applicable
SUBJECT SELECTION Inclusion exclusion criteria Subjects must be 75 years of age with AMI and ST-elevation or de novo LBBB eligible for thrombolytic therapy admitted in any Spanish medical center in which there is an active primary angioplasty program within the first 6 hours after symptom onset
Each patient must fulfill all inclusion criteria and none of the exclusion criteria
Inclusion criteria
1 Subjects of 75 or more years of age
2 Diagnosis of AMI chest pain or any symptom of myocardial ischemia of at least 20 minutes of duration not responding to nitrate therapy an evolution period of less than 6 hours after symptom onset until randomization process and at least one of the following alterations
1 ST-elevation 2 mm in 2 or more precordial leads
2 ST-elevation 1 mm in 2 or more anterior leads
3 Complete de novo or probably de novo left bundle branch block LBBB
3 Subject should be able to give informed consent prior to randomization process and should agree to fulfill all procedures described in the protocol including follow-up after hospital discharge A written consent signed by a close relative with witness is also acceptable
Exclusion criteria
1 Documented contraindication to the use of fibrinolytics 11 Internal active bleeding or known history of hemorrhagic diathesis 12 History of previous CVA of any kind or at any time 13 Intracranial tumor arteriovenous malformation aneurysm or cerebral aneurysm repair 14 Major surgery parenchymal biopsy ocular surgery or severe traumatism in the 6 weeks prior to randomization 15 Unexplained puncture in a non-compressible vascular location in the last 24 hours prior to randomization 16 Confirmed arterial hypertension with a reliable measurement of systolic AP 180 mmHg or diastolic AP 110 mmHg 17 Known thrombocytopenia 100000 plateletsmL 18 Prolonged 20 minutes or traumatic cardiopulmonar resuscitation CPR in the 2 weeks prior to randomization 19 History or signs suggesting aortic dissection
2 Cardiogenic shock
3 Estimated door-to-needle time 120 minutes
4 Administration of fibrinolysis in the 14 days prior to randomization
5 Administration of any glycoprotein IIaIIIb inhibitor in the 24 hours prior to randomization
6 Administration of any Low Molecular Weight Heparin LMWH in the 8 hours prior to randomization
7 Actual oral anticoagulant treatment
8 Suspected AMI secondary to occlusion of one lesion treated previously with a percutaneous coronary intervention within the previous 30 days for angioplasty or conventional stent and within the previous 12 months for coated stents
9 Dementia or acute confusional state at the time of randomization
10 Subject incapacity or unwillingness to give informed consent -at least verbally
11 Known renal failure basal creatinine 25 mgdl
12 Reduced life expectancy 12 months due to advanced or terminal concomitant condition
13 Subject participation in another clinical trial assessing a drug or a device in the 30 days prior to randomization
Diagnostic criteria for the pathologies of the study
Patients with a diagnosis of AMI presenting with
Chest pain or any symptom of myocardial ischemia of at least 20 minutes of duration not responding to nitrate therapy and an evolution period of less than 6 hours after symptom onset until randomization process with at least one of the following alterations
ST-elevation 2 mm in 2 or more precordial leads
ST-elevation 1 mm in 2 or more anterior leads
Complete de novo or probably de novo left bundle branch block LBBB
Estimate of sample size For the following conditions α 005 2 tailed power 80 β 020 and assuming a composite event incidence rate death reinfarction and disabling CVA based on previous registries 217 in the fibrinolysis group and 128 in the PA group a sample size of 282 patients per group is needed to demonstrate that difference 89 in absolute terms and 40 in relative terms Assuming a loss to follow-up rate of 1 the total number is 570 patients
Estimated loss of patients prior to randomization During a period of 3 months all patients meeting inclusion criteria who for any reason are not enrolled in the study will be included in a registry with an abbreviated CRF recording inclusionexclusion criteria the reason for non-enrollment and follow-up at 30 days and 12 months
Objectives General objective of the study To compare the efficacy and safety of primary angioplasty and fibrinolytic treatment in 75 year-old patients with AMI eligible for fibrinolytic therapy in Spanish medical centers with an active program of primary angioplasty
Primary end point Incidence of the combined end point of all-cause death re-infartion or disabling stroke at 30 days
Secondary end points
All-cause death at 30 days
Incidence of the combined end point of all-cause death disabling CVA or de novo heart failure at 30 days
Incidence of recurrent ischemia requiring emergency catheterization in the first 30 days
Cause of death at 30 days classified in three groups
1 Shock or heart pump failure
2 Mechanical complications ruptures or electromechanical dissociation
3 Other causes including bleeding
Incidence of major bleeding during hospital admission
All-cause mortality at 12 months
Period of time elapsed until presentation of any of the composite of all-cause death reinfarction or disabling CVA at 12 months
Period of time elapsed until the presentation of any composite of all-cause death reinfarction disabling CVA or non-elective hospital readmission for cardiac causes unstable angina heart failure non-elective coronary revascularization at 12 months
TYPE AND DESIGN OF THE CLINICAL TRIAL Clinical trial status Phase IV trial Description of randomization process The treatment strategy will be determined by a centralized randomization process using a telephone system Eligible patients will be randomized to one of two 2 treatment arms fibrinolytic treatment or primary angioplasty
Control and design This is a randomized multicenter open blind clinical trial designed to compare the efficacy and safety of primary angioplasty vs thrombolytic treatment in 75 year-old patients with AMI and ST-elevation or de novo LBBB eligible for thrombolysis admitted at Spanish medical centers that have an active primary angioplasty program within the first 6 hours after symptom onset
Masking techniques Being an open trial there are not masking techniques nor will there be an emergency opening procedure of emergency codes
Pre-inclusion clearance period Not applicable
SUBJECT SELECTION Inclusion exclusion criteria Subjects must be 75 years of age with AMI and ST-elevation or de novo LBBB eligible for thrombolytic therapy admitted in any Spanish medical center in which there is an active primary angioplasty program within the first 6 hours after symptom onset
Each patient must fulfill all inclusion criteria and none of the exclusion criteria
Inclusion criteria
1 Subjects of 75 or more years of age
2 Diagnosis of AMI chest pain or any symptom of myocardial ischemia of at least 20 minutes of duration not responding to nitrate therapy an evolution period of less than 6 hours after symptom onset until randomization process and at least one of the following alterations
1 ST-elevation 2 mm in 2 or more precordial leads
2 ST-elevation 1 mm in 2 or more anterior leads
3 Complete de novo or probably de novo left bundle branch block LBBB
3 Subject should be able to give informed consent prior to randomization process and should agree to fulfill all procedures described in the protocol including follow-up after hospital discharge A written consent signed by a close relative with witness is also acceptable
Exclusion criteria
1 Documented contraindication to the use of fibrinolytics 11 Internal active bleeding or known history of hemorrhagic diathesis 12 History of previous CVA of any kind or at any time 13 Intracranial tumor arteriovenous malformation aneurysm or cerebral aneurysm repair 14 Major surgery parenchymal biopsy ocular surgery or severe traumatism in the 6 weeks prior to randomization 15 Unexplained puncture in a non-compressible vascular location in the last 24 hours prior to randomization 16 Confirmed arterial hypertension with a reliable measurement of systolic AP 180 mmHg or diastolic AP 110 mmHg 17 Known thrombocytopenia 100000 plateletsmL 18 Prolonged 20 minutes or traumatic cardiopulmonar resuscitation CPR in the 2 weeks prior to randomization 19 History or signs suggesting aortic dissection
2 Cardiogenic shock
3 Estimated door-to-needle time 120 minutes
4 Administration of fibrinolysis in the 14 days prior to randomization
5 Administration of any glycoprotein IIaIIIb inhibitor in the 24 hours prior to randomization
6 Administration of any Low Molecular Weight Heparin LMWH in the 8 hours prior to randomization
7 Actual oral anticoagulant treatment
8 Suspected AMI secondary to occlusion of one lesion treated previously with a percutaneous coronary intervention within the previous 30 days for angioplasty or conventional stent and within the previous 12 months for coated stents
9 Dementia or acute confusional state at the time of randomization
10 Subject incapacity or unwillingness to give informed consent -at least verbally
11 Known renal failure basal creatinine 25 mgdl
12 Reduced life expectancy 12 months due to advanced or terminal concomitant condition
13 Subject participation in another clinical trial assessing a drug or a device in the 30 days prior to randomization
Diagnostic criteria for the pathologies of the study
Patients with a diagnosis of AMI presenting with
Chest pain or any symptom of myocardial ischemia of at least 20 minutes of duration not responding to nitrate therapy and an evolution period of less than 6 hours after symptom onset until randomization process with at least one of the following alterations
ST-elevation 2 mm in 2 or more precordial leads
ST-elevation 1 mm in 2 or more anterior leads
Complete de novo or probably de novo left bundle branch block LBBB
Estimate of sample size For the following conditions α 005 2 tailed power 80 β 020 and assuming a composite event incidence rate death reinfarction and disabling CVA based on previous registries 217 in the fibrinolysis group and 128 in the PA group a sample size of 282 patients per group is needed to demonstrate that difference 89 in absolute terms and 40 in relative terms Assuming a loss to follow-up rate of 1 the total number is 570 patients
Estimated loss of patients prior to randomization During a period of 3 months all patients meeting inclusion criteria who for any reason are not enrolled in the study will be included in a registry with an abbreviated CRF recording inclusionexclusion criteria the reason for non-enrollment and follow-up at 30 days and 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FIS PI042122 | None | None | None |