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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02777580




Registration number
NCT02777580
Ethics application status
Date submitted
13/05/2016
Date registered
19/05/2016

Titles & IDs
Public title
STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction
Scientific title
STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction
Secondary ID [1] 0 0
LRD.2016.STREAM2
Universal Trial Number (UTN)
Trial acronym
STREAM-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tenecteplase
Treatment: Drugs - Clopidogrel
Treatment: Surgery - Coronary angiography
Treatment: Surgery - Primary PCI

Experimental: Pharmaco-invasive strategy - 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.

Active comparator: Standard primary PCI - Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.


Treatment: Drugs: Tenecteplase
Half dose Tenecteplase

Treatment: Drugs: Clopidogrel
300 mg p.o. initial loading dose. Maintenance dose of 75 mg p.o. once daily. The maintenance dose of Clopidogrel (75 mg p.o. per day) should be continued for 1 year.

Treatment: Surgery: Coronary angiography
Coronary angiography followed by PCI or CABG if required, rescue PCI if required

Treatment: Surgery: Primary PCI
Primary PCI accoring to local standards
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of patients achieving = 50 % ST-segment resolution before and after PCI; needing rescue PCI; demonstrating TIMI flow grades (0,1,2,3); with aborted MI.
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Number of patients with stroke (total, intracranial haemorrhage, ischaemic, haemorrhagic conversion) and non-intracranial bleeds. Number of patients with serious cardiac events.
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
Composite endpoints (e.g. death, shock, heart failure and recurrent MI) will be assessed as described in the statistical analytical plan.
Timepoint [3] 0 0
30 days

Eligibility
Key inclusion criteria
1. Age equal or greater than 60 years
2. Onset of symptoms < 3 hours prior to randomisation
3. 12-lead ECG indicative of an acute STEMI (ST-elevation will be measured from the J point; scale: 1 mm per 0.1 mV):

* = 2 mm ST-elevation across 2 contiguous precordial leads (V1-V6) or leads I and aVL for a minimum combined total of = 4 mm ST-elevation or
* = 2 mm ST-elevation in 2 contiguous inferior leads (II, III, aVF) for a minimum combined total of = 4 mm ST-elevation
4. Informed consent received
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 1. Expected performance of PCI < 60 minutes from diagnosis (qualifying ECG) or inability to arrive at the catheterisation laboratory within 3 hours
2. Previous CABG
3. Left bundle branch block or ventricular pacing
4. Patients with cardiogenic shock - Killip Class 4
5. Patients with a body weight < 55 kg (known or estimated)
6. Uncontrolled hypertension, defined as sustained blood pressure = 180/110 mm Hg (systolic BP = 180 mm Hg and/or diastolic BP = 110 mm Hg) prior to randomisation
7. Known prior stroke or TIA
8. Recent administration of any i.v. or s.c. anticoagulation within 12 hours, including unfractionated heparin, enoxaparin, and/or bivalirudin or current use of oral anticoagulation (i.e. warfarin or a NOACs)
9. Active bleeding or known bleeding disorder/diathesis
10. Known history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) or recent trauma to the head or cranium (i.e. < 3 months)
11. Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current myocardial infarction)
12. Clinical diagnosis associated with increased risk of bleeding including known active peptic ulceration and/or neoplasm with increased bleeding risk
13. Prolonged cardiopulmonary resuscitation (> 2 minutes) within the past 2 weeks
14. Known acute pericarditis and/or subacute bacterial endocarditis
15. Known acute pancreatitis or known severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
16. Dementia
17. Known severe renal insufficiency
18. Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days
19. Known allergic reactions to tenecteplase, clopidogrel, enoxaparin and aspirin
20. Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk if the investigational therapy is initiated.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2023
Actual
Sample size
Target
Accrual to date
Final
609
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Liverpool Hospital - Cardiology Department - Liverpool
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Campinas
Country [2] 0 0
Canada
State/province [2] 0 0
Alberta
Country [3] 0 0
Chile
State/province [3] 0 0
Antofagasta
Country [4] 0 0
Chile
State/province [4] 0 0
Mejillones
Country [5] 0 0
Chile
State/province [5] 0 0
Melipilla
Country [6] 0 0
Chile
State/province [6] 0 0
Rancagua
Country [7] 0 0
Chile
State/province [7] 0 0
Santiago
Country [8] 0 0
Chile
State/province [8] 0 0
Talagante
Country [9] 0 0
Chile
State/province [9] 0 0
Tocopilla
Country [10] 0 0
France
State/province [10] 0 0
Bron
Country [11] 0 0
France
State/province [11] 0 0
Cahors
Country [12] 0 0
France
State/province [12] 0 0
Châteauroux
Country [13] 0 0
France
State/province [13] 0 0
Corbeil-Essonnes
Country [14] 0 0
France
State/province [14] 0 0
Le Chesnay
Country [15] 0 0
France
State/province [15] 0 0
Lille
Country [16] 0 0
France
State/province [16] 0 0
Lyon
Country [17] 0 0
France
State/province [17] 0 0
Melun
Country [18] 0 0
France
State/province [18] 0 0
Montauban
Country [19] 0 0
France
State/province [19] 0 0
Rennes
Country [20] 0 0
France
State/province [20] 0 0
Vienne
Country [21] 0 0
Mexico
State/province [21] 0 0
Mexico City
Country [22] 0 0
Montenegro
State/province [22] 0 0
Bar
Country [23] 0 0
Montenegro
State/province [23] 0 0
Cetinje
Country [24] 0 0
Montenegro
State/province [24] 0 0
Nikšic
Country [25] 0 0
Montenegro
State/province [25] 0 0
Podgorica
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Kemerovo
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Tomsk
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Tver
Country [29] 0 0
Serbia
State/province [29] 0 0
Belgrade
Country [30] 0 0
Serbia
State/province [30] 0 0
Cuprija
Country [31] 0 0
Serbia
State/province [31] 0 0
Jagodina
Country [32] 0 0
Serbia
State/province [32] 0 0
Kragujevac
Country [33] 0 0
Serbia
State/province [33] 0 0
Pancevo
Country [34] 0 0
Serbia
State/province [34] 0 0
Smederevo
Country [35] 0 0
Serbia
State/province [35] 0 0
Sremska Kamenica
Country [36] 0 0
Serbia
State/province [36] 0 0
Vrbas
Country [37] 0 0
Serbia
State/province [37] 0 0
Vršac
Country [38] 0 0
Serbia
State/province [38] 0 0
Šabac
Country [39] 0 0
Spain
State/province [39] 0 0
Málaga

Funding & Sponsors
Primary sponsor type
Other
Name
KU Leuven
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Boehringer Ingelheim
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Life Sciences Research Partners
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Fund for Clinical Cardiovascular Research at LRD
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Frans Van de Werf, MD, PhD
Address 0 0
KU Leuven
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02777580