Myocardial Infarction
Conditions
Brief summary
This study aims at evaluating, in a proof of concept approach, the outcome of patients presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in either a pre-hospital setting or community hospital emergency room without a PCI facility. Following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 6-24 hours with timely coronary intervention as appropriate (or by rescue coronary intervention if required) in Group A will be compared to primary PCI performed according to local standards in Group B. The study is exploratory in nature and will examine this medical question. The efficacy and safety endpoints as well as mixed (efficacy and safety) composite endpoints up to or before 30 days following randomisation will be evaluated. All clinical endpoints of main interest will be assessed as single or composite endpoints for evaluation of the trial objective. All statistical tests are of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.
Interventions
PROCEDUREprimary PCI
Standard primary PCI
DRUGenoxaparin
Adjunctive treatment
PROCEDUREcatheterisation
Routine or rescue coronary intervention
DRUGtenecteplase
Single, weight-adjusted i.v. bolus of tenecteplase
DRUGclopidogrel
Adjunctive treatment
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age equal or greater than 18 years 2. Onset of symptoms \< 3 hours prior to randomisation 3.12-lead ECG indicative of an acute STEMI 4.Informed consent received
Exclusion criteria
Medical history, procedures, medication administration or the presence of factors that would in general predispose to bleeding events and/or the inability to evaluate the study primary endpoint
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With All-cause Mortality, Cardiogenic Shock, Congestive Heart Failure and Recurrent Myocardial Infarction Within 30 Days for FAS. | 30 days | The number of observed patients with all-cause mortality, cardiogenic shock, congestive heart failure (CHF) and recurrent myocardial infarction within 30 days was reported for full analysis set (FAS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Cardiac Mortality | 30 days | This is a key secondary endpoint. The number of observed patients with cardiac mortality within 30 days was reported. |
| Number of Patients With Cardiogenic Shock | 30 days | This is a key secondary endpoint. The number of observed patients with cardiogenic shock within 30 days was reported. |
| Number of Patients With Congestive Heart Failure (CHF) | 30 days | This is a key secondary endpoint. The number of observed patients with congestive heart failure (CHF) within 30 days was reported. |
| Number of Patients With Recurrent Myocardial Infarction (Reinfarction) | 30 days | This is a key secondary endpoint. The number of observed patients with recurrent myocardial infarction (reinfarction) within 30 days was reported |
| Number of Patients With Rehospitalisation for Cardiac Reasons | 30 days | This is a key secondary endpoint. The number of observed patients with rehospitalisation for cardiac reasons within 30 days was reported |
| Number of Patients With Rehospitalisation for Non-cardiac Reasons | 30 days | This is a key secondary endpoint. The number of observed patients with rehospitalisation for non-cardiac reasons within 30 days was reported |
| Number of Patients With Serious Repeat Target Vessel Revascularization | 30 days | This is a key secondary endpoint. The number of observed patients with serious repeat target vessel revascularization within 30 days was reported |
| Number of Patients With All Cause Death and Shock | 30 days | This is a key secondary endpoint. The number of observed patients with all cause death and shock within 30 days was reported |
| Number of Patients With All Cause Death and Shock and CHF | 30 days | This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF within 30 days was reported. |
| Number of Patients With All Cause Death and Shock and Reinfarction | 30 days | This is a key secondary endpoint. The number of observed patients with all cause death and shock and reinfarction within 30 days was reported |
| Number of Patients With Total Fatal Stroke | 30 days | This is a key secondary endpoint. The number of observed patients with total fatal stroke within 30 days was reported |
| Number of Patients With All Cause Mortality | 30 days | This is a key secondary endpoint. The number of observed patients with all cause mortality within 30 days was reported. |
| Number of Patients With Total Non-disabling Stroke | 30 days | This is a key secondary endpoint. The number of observed patients with total non-disabling stroke within 30 days was reported |
| Number of Patients With Intracranial Haemorrhage | 30 days | This is a key secondary endpoint. The number of observed patients with intracranial haemorrhage within 30 days was reported |
| Number of Patients With Ischaemic Stroke | 30 days | This is a key secondary endpoint. The number of observed patients with ischaemic stroke within 30 days was reported |
| Number of Patients With Total Stroke (All Types) | 30 days | This is a key secondary endpoint. The number of observed patients with total stroke (all types) within 30 days was reported |
| Number of Patients With Major Non-intracranial Bleeds Including Blood Transfusions | 30 days | This is a key secondary endpoint. The number of observed patients with major non-intracranial bleeds including blood transfusions within 30 days was reported |
| Number of Patients With Minor Non-intracranial Bleeds | 30 days | This is a key secondary endpoint. The number of observed patients with minor non-intracranial bleeds within 30 days was reported |
| Number of Patients With Total Non-intracranial Bleeds | 30 days | This is a key secondary endpoint. The number of observed patients with total non-intracranial bleeds within 30 days was reported |
| Number of Patients With Serious Resuscitated Ventricular Fibrillation | 30 days | This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation within 30 days was reported |
| Number of Patients With Serious Resuscitated Ventricular Fibrillation in Association With Invasive Procedures | 30 days | This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation in association with invasive procedures (occurring at any time during catheterisation or urgent/elective PCI) within 30 days was reported |
| Number of Patients With All Cause Death and Non-fatal Stroke | 30 days | This is a key secondary endpoint. The number of observed patients with all cause death and non-fatal stroke within 30 days was reported |
| Number of Patients With All Cause Death and Shock and CHF and Reinfarction and Disabling Stroke | 30 days | This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF and reinfarction and disabling stroke within 30 days was reported |
| Number of Patients With Total Disabling Stroke | 30 days | This is a key secondary endpoint. The number of observed patients with total disabling stroke within 30 days was reported |
Countries
Austria, Belgium, Brazil, Canada, Chile, France, Germany, Greece, Italy, Norway, Peru, Poland, Russia, Serbia, Spain, United Kingdom
Participant flow
Recruitment details
Open-label, prospective, randomised, parallel, comparative international multicentre trial
Pre-assignment details
All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated.
Participants by arm
| Arm | Count |
|---|---|
| Tenecteplase (Group A) Patients were administered Tenecteplase in a weight-adjusted dose regimen with clopidogrel (concomitant antiplatelet) and Enoxaparin (anticoagulant treatment) followed by timely coronary intervention (pharmacoinvasive treatment) | 949 |
| Primary PCI (Group B) Patients received primary Percutaneous Coronary Intervention (PCI) according to local standards.
Preceding and concomitant medication in particular antiplatelet and antithrombin drugs were to be given according to local standards and international guidelines. | 948 |
| Total | 1,897 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Previous enrolment into this study | 1 | 1 |
Baseline characteristics
| Characteristic | Tenecteplase (Group A) | Primary PCI (Group B) | Total |
|---|---|---|---|
| Age, Continuous | 60 Years STANDARD_DEVIATION 12.42 | 60 Years STANDARD_DEVIATION 12.49 | 60 Years STANDARD_DEVIATION 12.46 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 195 Participants | 208 Participants | 403 Participants |
| Sex: Female, Male Male | 754 Participants | 740 Participants | 1494 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 43 / 949 | 42 / 948 |
| other Total, other adverse events | 0 / 949 | 0 / 948 |
| serious Total, serious adverse events | 146 / 949 | 164 / 948 |
Outcome results
Primary
Number of Patients With All-cause Mortality, Cardiogenic Shock, Congestive Heart Failure and Recurrent Myocardial Infarction Within 30 Days for FAS.
The number of observed patients with all-cause mortality, cardiogenic shock, congestive heart failure (CHF) and recurrent myocardial infarction within 30 days was reported for full analysis set (FAS).
Time frame: 30 days
Population: Full analysis set (FAS): All consented patients either randomised by Interactive Voice Response System (IVRS) or treated (i.e., manually allocated to treatment group) by the investigator. This population is also referred to as the intention-to-treat population (ITT).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With All-cause Mortality, Cardiogenic Shock, Congestive Heart Failure and Recurrent Myocardial Infarction Within 30 Days for FAS. | 116 Participants |
| Primary PCI (Group B) | Number of Patients With All-cause Mortality, Cardiogenic Shock, Congestive Heart Failure and Recurrent Myocardial Infarction Within 30 Days for FAS. | 135 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.19595% CI: [0.68, 1.08]modified Poisson regression model
Secondary
Number of Patients With All Cause Death and Non-fatal Stroke
This is a key secondary endpoint. The number of observed patients with all cause death and non-fatal stroke within 30 days was reported
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With All Cause Death and Non-fatal Stroke | 50 Participants |
| Primary PCI (Group B) | Number of Patients With All Cause Death and Non-fatal Stroke | 43 Participants |
p-value: 0.45195% CI: [0.78, 1.73]modified Poisson regression model
Secondary
Number of Patients With All Cause Death and Shock
This is a key secondary endpoint. The number of observed patients with all cause death and shock within 30 days was reported
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With All Cause Death and Shock | 59 Participants |
| Primary PCI (Group B) | Number of Patients With All Cause Death and Shock | 73 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.20795% CI: [0.58, 1.13]modified Poission Regression model
Secondary
Number of Patients With All Cause Death and Shock and CHF
This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF within 30 days was reported.
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With All Cause Death and Shock and CHF | 100 Participants |
| Primary PCI (Group B) | Number of Patients With All Cause Death and Shock and CHF | 123 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.195% CI: [0.63, 1.04]modified Poission Regression model
Secondary
Number of Patients With All Cause Death and Shock and CHF and Reinfarction and Disabling Stroke
This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF and reinfarction and disabling stroke within 30 days was reported
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With All Cause Death and Shock and CHF and Reinfarction and Disabling Stroke | 117 Participants |
| Primary PCI (Group B) | Number of Patients With All Cause Death and Shock and CHF and Reinfarction and Disabling Stroke | 135 Participants |
p-value: 0.2295% CI: [0.69, 1.09]modified Poisson regression model
Secondary
Number of Patients With All Cause Death and Shock and Reinfarction
This is a key secondary endpoint. The number of observed patients with all cause death and shock and reinfarction within 30 days was reported
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With All Cause Death and Shock and Reinfarction | 77 Participants |
| Primary PCI (Group B) | Number of Patients With All Cause Death and Shock and Reinfarction | 85 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.51195% CI: [0.67, 1.22]modified Poission Regression model
Secondary
Number of Patients With All Cause Mortality
This is a key secondary endpoint. The number of observed patients with all cause mortality within 30 days was reported.
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With All Cause Mortality | 43 Participants |
| Primary PCI (Group B) | Number of Patients With All Cause Mortality | 42 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.90495% CI: [0.68, 1.55]modified Poisson regression
Secondary
Number of Patients With Cardiac Mortality
This is a key secondary endpoint. The number of observed patients with cardiac mortality within 30 days was reported.
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With Cardiac Mortality | 31 Participants |
| Primary PCI (Group B) | Number of Patients With Cardiac Mortality | 32 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.90595% CI: [0.6, 1.58]modified Poisson regression model
Secondary
Number of Patients With Cardiogenic Shock
This is a key secondary endpoint. The number of observed patients with cardiogenic shock within 30 days was reported.
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With Cardiogenic Shock | 41 Participants |
| Primary PCI (Group B) | Number of Patients With Cardiogenic Shock | 56 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.1295% CI: [0.49, 1.08]modified Poisson regression model
Secondary
Number of Patients With Congestive Heart Failure (CHF)
This is a key secondary endpoint. The number of observed patients with congestive heart failure (CHF) within 30 days was reported.
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With Congestive Heart Failure (CHF) | 57 Participants |
| Primary PCI (Group B) | Number of Patients With Congestive Heart Failure (CHF) | 72 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.1795% CI: [0.57, 1.11]modified Poisson regression model
Secondary
Number of Patients With Intracranial Haemorrhage
This is a key secondary endpoint. The number of observed patients with intracranial haemorrhage within 30 days was reported
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With Intracranial Haemorrhage | 9 Participants |
| Primary PCI (Group B) | Number of Patients With Intracranial Haemorrhage | 2 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.05495% CI: [0.98, 20.82]modified Poisson regression model
Secondary
Number of Patients With Ischaemic Stroke
This is a key secondary endpoint. The number of observed patients with ischaemic stroke within 30 days was reported
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With Ischaemic Stroke | 6 Participants |
| Primary PCI (Group B) | Number of Patients With Ischaemic Stroke | 3 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.32495% CI: [0.5, 7.99]modified Poisson regression model
Secondary
Number of Patients With Major Non-intracranial Bleeds Including Blood Transfusions
This is a key secondary endpoint. The number of observed patients with major non-intracranial bleeds including blood transfusions within 30 days was reported
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With Major Non-intracranial Bleeds Including Blood Transfusions | 61 Participants |
| Primary PCI (Group B) | Number of Patients With Major Non-intracranial Bleeds Including Blood Transfusions | 45 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.11195% CI: [0.93, 1.97]modified Poisson regression model
Secondary
Number of Patients With Minor Non-intracranial Bleeds
This is a key secondary endpoint. The number of observed patients with minor non-intracranial bleeds within 30 days was reported
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With Minor Non-intracranial Bleeds | 206 Participants |
| Primary PCI (Group B) | Number of Patients With Minor Non-intracranial Bleeds | 191 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.39795% CI: [0.91, 1.28]modified Poisson regression model
Secondary
Number of Patients With Recurrent Myocardial Infarction (Reinfarction)
This is a key secondary endpoint. The number of observed patients with recurrent myocardial infarction (reinfarction) within 30 days was reported
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With Recurrent Myocardial Infarction (Reinfarction) | 23 Participants |
| Primary PCI (Group B) | Number of Patients With Recurrent Myocardial Infarction (Reinfarction) | 21 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.75895% CI: [0.61, 1.97]modified Poisson regression model
Secondary
Number of Patients With Rehospitalisation for Cardiac Reasons
This is a key secondary endpoint. The number of observed patients with rehospitalisation for cardiac reasons within 30 days was reported
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With Rehospitalisation for Cardiac Reasons | 45 Participants |
| Primary PCI (Group B) | Number of Patients With Rehospitalisation for Cardiac Reasons | 41 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.66395% CI: [0.73, 1.66]modified Poisson regression model
Secondary
Number of Patients With Rehospitalisation for Non-cardiac Reasons
This is a key secondary endpoint. The number of observed patients with rehospitalisation for non-cardiac reasons within 30 days was reported
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With Rehospitalisation for Non-cardiac Reasons | 19 Participants |
| Primary PCI (Group B) | Number of Patients With Rehospitalisation for Non-cardiac Reasons | 11 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.14895% CI: [0.82, 3.6]modified Poisson regression model
Secondary
Number of Patients With Serious Repeat Target Vessel Revascularization
This is a key secondary endpoint. The number of observed patients with serious repeat target vessel revascularization within 30 days was reported
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With Serious Repeat Target Vessel Revascularization | 1 Participants |
| Primary PCI (Group B) | Number of Patients With Serious Repeat Target Vessel Revascularization | 2 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.57295% CI: [0.05, 5.52]modified Poisson regression model
Secondary
Number of Patients With Serious Resuscitated Ventricular Fibrillation
This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation within 30 days was reported
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With Serious Resuscitated Ventricular Fibrillation | 32 Participants |
| Primary PCI (Group B) | Number of Patients With Serious Resuscitated Ventricular Fibrillation | 38 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.47195% CI: [0.53, 1.34]modified Poisson regression model
Secondary
Number of Patients With Serious Resuscitated Ventricular Fibrillation in Association With Invasive Procedures
This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation in association with invasive procedures (occurring at any time during catheterisation or urgent/elective PCI) within 30 days was reported
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With Serious Resuscitated Ventricular Fibrillation in Association With Invasive Procedures | 10 Participants |
| Primary PCI (Group B) | Number of Patients With Serious Resuscitated Ventricular Fibrillation in Association With Invasive Procedures | 29 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.00395% CI: [0.17, 0.71]modified Poisson regression model
Secondary
Number of Patients With Total Disabling Stroke
This is a key secondary endpoint. The number of observed patients with total disabling stroke within 30 days was reported
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With Total Disabling Stroke | 2 Participants |
| Primary PCI (Group B) | Number of Patients With Total Disabling Stroke | 0 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.16895% CI: [0.51, 49.08]modified Poisson regression model
Secondary
Number of Patients With Total Fatal Stroke
This is a key secondary endpoint. The number of observed patients with total fatal stroke within 30 days was reported
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With Total Fatal Stroke | 7 Participants |
| Primary PCI (Group B) | Number of Patients With Total Fatal Stroke | 4 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.36995% CI: [0.52, 5.97]modified Poisson regression model
Secondary
Number of Patients With Total Non-disabling Stroke
This is a key secondary endpoint. The number of observed patients with total non-disabling stroke within 30 days was reported
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With Total Non-disabling Stroke | 8 Participants |
| Primary PCI (Group B) | Number of Patients With Total Non-disabling Stroke | 1 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.04995% CI: [1, 63.97]modified Poisson regression model
Secondary
Number of Patients With Total Non-intracranial Bleeds
This is a key secondary endpoint. The number of observed patients with total non-intracranial bleeds within 30 days was reported
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With Total Non-intracranial Bleeds | 267 Participants |
| Primary PCI (Group B) | Number of Patients With Total Non-intracranial Bleeds | 236 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.10795% CI: [0.97, 1.31]modified Poisson regression model
Secondary
Number of Patients With Total Stroke (All Types)
This is a key secondary endpoint. The number of observed patients with total stroke (all types) within 30 days was reported
Time frame: 30 days
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenecteplase (Group A) | Number of Patients With Total Stroke (All Types) | 15 Participants |
| Primary PCI (Group B) | Number of Patients With Total Stroke (All Types) | 5 Participants |
Comparison: No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.p-value: 0.03295% CI: [1.1, 8.24]modified Poisson regression model