Clinical Trial Results:
STREAM-2 (STrategic Reperfusion in elderly patients Early After Myocardial Infarction)
|
Summary
|
|
EudraCT number |
2016-001642-26 |
Trial protocol |
ES RO |
Global end of trial date |
30 Sep 2023
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
08 Feb 2024
|
First version publication date |
08 Feb 2024
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
LRD.2016.STREAM2
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT02777580 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
KU Leuven LRD
|
||
Sponsor organisation address |
Waaistraat 6, Leuven, Belgium, 3000
|
||
Public contact |
Frans Van de Werf, Leuven Coordinating Center, frans.vandewerf@kuleuven.be
|
||
Scientific contact |
Frans Van de Werf, Leuven Coordinating Center, frans.vandewerf@kuleuven.be
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
13 Oct 2023
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
30 Sep 2023
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
In elderly patients ≥ 70yrs with acute ST-elevation myocardial infarction randomised within 3 hours of onset of symptoms the efficacy and safety of a strategy of early fibrinolytic treatment with half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by catheterisation within 6-24 hours or rescue coronary intervention as required, will be compared to a strategy of primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
|
||
Protection of trial subjects |
see protocol
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 Feb 2017
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
Yes
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Chile: 15
|
||
Country: Number of subjects enrolled |
France: 42
|
||
Country: Number of subjects enrolled |
Spain: 10
|
||
Country: Number of subjects enrolled |
Australia: 9
|
||
Country: Number of subjects enrolled |
Brazil: 20
|
||
Country: Number of subjects enrolled |
Canada: 100
|
||
Country: Number of subjects enrolled |
Mexico: 81
|
||
Country: Number of subjects enrolled |
Montenegro: 8
|
||
Country: Number of subjects enrolled |
Russian Federation: 142
|
||
Country: Number of subjects enrolled |
Serbia: 177
|
||
Worldwide total number of subjects |
604
|
||
EEA total number of subjects |
52
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
160
|
||
From 65 to 84 years |
406
|
||
85 years and over |
38
|
||
|
||||||||||
|
Recruitment
|
||||||||||
Recruitment details |
see protocol | |||||||||
|
Pre-assignment
|
||||||||||
Screening details |
see inclusion criteria protocol | |||||||||
|
Period 1
|
||||||||||
Period 1 title |
30 day period (overall period)
|
|||||||||
Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
|
|||||||||
Blinding used |
Not blinded | |||||||||
|
Arms
|
||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||
|
Arm title
|
Pharmaco-invasive strategy | |||||||||
Arm description |
Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Tenecteplase
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
TNKase, metalyse
|
|||||||||
Pharmaceutical forms |
Concentrate for solution for injection/infusion
|
|||||||||
Routes of administration |
Intravenous bolus use
|
|||||||||
Dosage and administration details |
50 or 40 mg of drug reconstituted in 10 or 8 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds
|
|||||||||
|
Arm title
|
Standard primary PCI | |||||||||
Arm description |
Primary PCI according to local standards | |||||||||
Arm type |
standard procedure | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
|
|||||||||
|
||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Pharmaco-invasive strategy
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Standard primary PCI
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Primary PCI according to local standards | ||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Pharmaco-invasive strategy
|
||
Reporting group description |
Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required. | ||
Reporting group title |
Standard primary PCI
|
||
Reporting group description |
Primary PCI according to local standards | ||
|
||||||||||
End point title |
successful reperfusion | |||||||||
End point description |
||||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
30 days
|
|||||||||
|
||||||||||
Statistical analysis title |
Succesfull reperfusion | |||||||||
Comparison groups |
Standard primary PCI v Pharmaco-invasive strategy
|
|||||||||
Number of subjects included in analysis |
548
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
other | |||||||||
P-value |
= 0.05 | |||||||||
Method |
Chi-squared | |||||||||
Confidence interval |
||||||||||
|
||||||||||
End point title |
Composite clinical efficacy endpoint: all cause death, shock, CHF and reinfarction | |||||||||
End point description |
||||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
30 days
|
|||||||||
|
||||||||||
Statistical analysis title |
Relative risk | |||||||||
Comparison groups |
Pharmaco-invasive strategy v Standard primary PCI
|
|||||||||
Number of subjects included in analysis |
604
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
other | |||||||||
Method |
||||||||||
Parameter type |
Risk ratio (RR) | |||||||||
Point estimate |
0.96
|
|||||||||
Confidence interval |
||||||||||
level |
95% | |||||||||
sides |
2-sided
|
|||||||||
lower limit |
0.62 | |||||||||
upper limit |
1.48 | |||||||||
|
||||||||||
End point title |
Total stroke | |||||||||
End point description |
||||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
30 days
|
|||||||||
|
||||||||||
Statistical analysis title |
Relative risk | |||||||||
Comparison groups |
Pharmaco-invasive strategy v Standard primary PCI
|
|||||||||
Number of subjects included in analysis |
603
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
other | |||||||||
Method |
||||||||||
Parameter type |
Risk ratio (RR) | |||||||||
Point estimate |
4.57
|
|||||||||
Confidence interval |
||||||||||
level |
95% | |||||||||
sides |
2-sided
|
|||||||||
lower limit |
0.58 | |||||||||
upper limit |
35.8 | |||||||||
|
|||
|
Adverse events information [1]
|
|||
Timeframe for reporting adverse events |
30 days
|
||
Assessment type |
Systematic | ||
|
Dictionary used for adverse event reporting
|
|||
Dictionary name |
MedDRA | ||
Dictionary version |
19
|
||
| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: a treshold of 5% was applied for non serious adverse events |
|||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
