Myocardial InfarctionPhase 4STREAM-2NCT02777580
STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction
A Phase 4 study testing Tenecteplase, Clopidogrel and Coronary angiography in people with Myocardial Infarction, run by KU Leuven at 50 sites in 10 countries.
Trial summary
In patients ≥ 60yrs 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Tenecteplase, Clopidogrel and Coronary angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 609 participants
- Where
- 50 sitesin 10 countries
- Study dates
- 1 Aug 2017to 30 Sep 2023
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age equal or greater than 60 years
- Onset of symptoms < 3 hours prior to randomisation
- 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
- Informed consent received
Who cannot join
- 1. Expected performance of PCI < 60 minutes from diagnosis (qualifying ECG) or inability to arrive at the catheterisation laboratory within 3 hours
- Previous CABG
- Left bundle branch block or ventricular pacing
- Patients with cardiogenic shock - Killip Class 4
- Patients with a body weight < 55 kg (known or estimated)
- 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
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- Known prior stroke or TIA
- 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)
- Active bleeding or known bleeding disorder/diathesis
- 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)
- 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)
- Clinical diagnosis associated with increased risk of bleeding including known active peptic ulceration and/or neoplasm with increased bleeding risk
- Prolonged cardiopulmonary resuscitation (> 2 minutes) within the past 2 weeks
- Known acute pericarditis and/or subacute bacterial endocarditis
- Known acute pancreatitis or known severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
- Dementia
- Known severe renal insufficiency
- Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days
- Known allergic reactions to tenecteplase, clopidogrel, enoxaparin and aspirin
- 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.
Trial locations and contacts
50 sites in 10 countries.
50 sites in 10 countries
Serbia12 sites
Clinical Center of Serbia, Cardiology Clinic
Belgrade, 11000
Military Medical Academy, Clinic for Emergency Internal Medicine
Belgrade, 11000
Institute for cardiovascular diseases Dedinje, Cardiovascular research sector
Belgrade, 11040
General Hospital Cuprija, Cardiology Department
Ćuprija, 35230
General Hospital Jagodina/Intenal Medicine department
Jagodina, 35000
Institute for cardiovascular diseases Vojvodina - Sremska Kamenica, Cardiology Clinic
Kamenitz, 21204
Clinical Center Kragujevac, Cardiology Clinic
Kragujevac, 34000
General Hospital Pancevo/Department of internal medicine - cardiology section
Pančevo, 26000
General Hospital "Dr. Laza K. Lazarevic" Sabac, Internal medicine department
Šabac, 15000
General Hospital "Sveti Luka" Smederevo, Dept of Internal Med - Cardiology Section
Smederevo, 11300
Opsta bolnica Vrbas, Cardiology Department
Vrbas
General Hospital Vrsac/Cardiology department with coronary unit
Vršac, 26300
France11 sites
CH Louis Pradel - Hospices civils de Lyon
Bron, 69677
CH Cahors - SAMU 46
Cahors, 46005
CH de Chateauroux
Châteauroux, 36019
CH Sud Francilien - Service Cardiologie
Corbeil-Essonnes, 91106
Centre Hospitalier de Versailles
Le Chesnay, 78157
CHRU de Lille
Lille, 59037
CH St. Joseph - St Luc - Lyon
Lyon, 69365
Groupe Hospitalier Sud Ile de France - CH de Melun - Service SAMU 77
Melun
Clinque du Pont de Chaume
Montauban, 82000
CHU de Rennes
Rennes
CH Lucien Hussel
Vienne, 38209
Chile8 sites
Hospital Regional de Antofagasta
Antofagasta, 1240801
Hospital Comunitario de Mejillones
Mejillones, 1310000
Hospital de Melipilla
Melipilla
Hospital Regional de Rancagua
Rancagua, 2820000
SAR Rancagua
Rancagua, 2830945
Hospital San Juan de Dios
Santiago, 8350488
Hospital de Talagante
Talagante, 9670468
Hospital de Tocopilla
Tocopilla, 1340000
Russia6 sites
Federal State Budgetary Inst "Research Inst. for Complex Issues of Card. Diseases"
Kemerovo
State Budgetary Healthcare Inst. Kemerovo-Clinical Emergency Care Station
Kemerovo
Federal State Budgetary Scientific Inst "Tomsk Nat Research Med.Center of Russian Academy Sciences"
Tomsk, 634012
Tomsk Regional State Autonomous Healthcare Institution Emergency Care Station
Tomsk, 634059
State Budgetary Healthcare Institution of Tverskoy Region "Region Clinical Hospital"
Tver'
Tver Region State Budgetary Healthcare Institution "Tver Emergency Station"
Tver'
Montenegro4 sites
JZU Blazo Orlandic
Bar
General Hospital Danilo the First Cetinje
Cetinje
General Hospital of Niksic
Nikšić
Clinical Centar of Montenegro
Podgorica
Spain4 sites
Hospital Virgen de la Victoria, Unidad de Cuidados Intensivos
Málaga, 29010
Hospital de Antequera, Unidad de Cuidados Intensivos
Málaga, 29200
Hospital Serrania Ronda, Unidad de Cuidados Intensivos
Málaga, 29400
Hospital Comarcal Axarquia, Unidad de Cuidados Intensivos
Málaga, 29740
Mexico2 sites
Hospital Gea Gonzalez
Mexico City, 14080
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, 14080
Brazil1 site
Centro de Pesquisa São Lucas - Hospital E Maternidade Celso Pierro
Campinas
About this study
In patients ≥ 60yrs 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.
- Conditions
- Myocardial Infarction
- Being tested
- Tenecteplase, Clopidogrel, Coronary angiography, Primary PCI
- Keywords
- Thrombolytic Therapy, Primary PCI
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenecteplaseDrug
Also called TNKase, Metalyse
Half dose Tenecteplase
ClopidogrelDrug
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.
Coronary angiographyProcedure or surgery
Coronary angiography followed by PCI or CABG if required, rescue PCI if required
Primary PCIProcedure or surgery
Primary PCI accoring to local standards
| Study group | Role | What they receive |
|---|---|---|
| Pharmaco-invasive strategy | Experimental | 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. Receives: Drug: Tenecteplase; Drug: Clopidogrel; Procedure: Coronary angiography |
| Standard primary PCI | Active comparator | Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards. Receives: Procedure: Primary PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Reperfusion
Worst-lead ST-segment elevation resolution ≥ 50% 30 min post angiogram/PCI
Measured: 30 min post angiogram/PCI
Composite Clinical Efficacy End Point: All Cause Death, Shock, CHF and Reinfarction at 30 Days
Measured: 30 days
Total Stroke
Number of patients with stroke (intracranial haemorrhage, ischaemic, haemorrhagic conversion)
Measured: 30 days
Major Non-intrancranial Bleedings
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study start1 Aug 2017
- Primary completion13 Oct 2022
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 609 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim, Life Sciences Research Partners, Frans Van de Werf Fund for Clinical Cardiovascular Research
- Responsible party
- Principal investigator, Frans Van de Werf, KU Leuven
- Investigators
- Frans Van de Werf, MD, PhD, Study chair, KU LeuvenPaul Armstrong, MD, Study chair, University of Alberta, Edmonton, CanadaPeter Sinnaeve, MD, PhD, Principal investigator, UZ Leuven, BelgiumRobert Welsh, MD, Principal investigator, University of Alberta, Edmonton, CanadaPatrick Goldstein, MD, Principal investigator, Lille University Hospital, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777580
- Sponsor's protocol ID
- LRD.2016.STREAM2
- Acronym
- STREAM-2
- Status last verified
- Jul 2024
- First submitted
- 13 May 2016
- Last updated
- 4 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Armstrong PW, Gershlick AH, Goldstein P, Wilcox R, Danays T, Lambert Y, Sulimov V, Rosell Ortiz F, Ostojic M, Welsh RC, Carvalho AC, Nanas J, Arntz HR, Halvorsen S, Huber K, Grajek S, Fresco C, Bluhmki E, Regelin A, Vandenberghe K, Bogaerts K, Van de Werf F; STREAM Investigative Team. Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction. N Engl J Med. 2013 Apr 11;368(15):1379-87. doi: 10.1056/NEJMoa1301092. Epub 2013 Mar 10.
PubMed 23473396Sinnaeve PR, Armstrong PW, Gershlick AH, Goldstein P, Wilcox R, Lambert Y, Danays T, Soulat L, Halvorsen S, Ortiz FR, Vandenberghe K, Regelin A, Bluhmki E, Bogaerts K, Van de Werf F; STREAM investigators. ST-segment-elevation myocardial infarction patients randomized to a pharmaco-invasive strategy or primary percutaneous coronary intervention: Strategic Reperfusion Early After Myocardial Infarction (STREAM) 1-year mortality follow-up. Circulation. 2014 Sep 30;130(14):1139-45. doi: 10.1161/CIRCULATIONAHA.114.009570. Epub 2014 Aug 26.
PubMed 25161043Dianati Maleki N, Van de Werf F, Goldstein P, Adgey JA, Lambert Y, Sulimov V, Rosell-Ortiz F, Gershlick AH, Zheng Y, Westerhout CM, Armstrong PW. Aborted myocardial infarction in ST-elevation myocardial infarction: insights from the STrategic Reperfusion Early After Myocardial infarction trial. Heart. 2014 Oct;100(19):1543-9. doi: 10.1136/heartjnl-2014-306023. Epub 2014 Jun 10.
PubMed 24916050Sinnaeve PR, Danays T, Bogaerts K, Van de Werf F, Armstrong PW. Drug Treatment of STEMI in the Elderly: Focus on Fibrinolytic Therapy and Insights from the STREAM Trial. Drugs Aging. 2016 Feb;33(2):109-18. doi: 10.1007/s40266-016-0345-6.
PubMed 26849132Armstrong PW, Zheng Y, Welsh RC, Sinnaeve PR, Van de Werf F, Westerhout CM, Bainey KR. Primary percutaneous coronary intervention within the first hour: Insights from early-treated patients with ST-elevation myocardial infarction. Am Heart J. 2026 May;295:107363. doi: 10.1016/j.ahj.2026.107363. Epub 2026 Jan 29.
PubMed 41619999Bainey KR, Welsh RC, Zheng Y, Arias-Mendoza A, Ristic AD, Averkov OV, Lambert Y, Temple T, Ly E, Bogaerts K, Sinnaeve P, Westerhout CM, Van de Werf F, Armstrong PW; STREAM-2 Investigators. Pharmaco-invasive strategy and dosing of tenecteplase in STEMI patients 60 to <75 years: An inter-trial comparison of the STREAM-1 and STREAM-2 trials. Am Heart J. 2025 Jun;284:20-31. doi: 10.1016/j.ahj.2025.02.002. Epub 2025 Feb 12.
PubMed 39952376Bainey KR, Welsh RC, Zheng Y, Arias-Mendoza A, Ristic AD, Averkov OV, Lambert Y, Kerr Saraiva JF, Sepulveda P, Rosell-Ortiz F, French JK, Music LB, Temple T, Ly E, Bogaerts K, Sinnaeve PR, Danays T, Westerhout CM, Van de Werf F, Armstrong PW; STREAM-2 Investigators. Pharmaco-Invasive Strategy With Half-Dose Tenecteplase in Patients With STEMI: Prespecified Pooled Analysis of Patients Aged >/=75 Years in STREAM-1 and 2. Circ Cardiovasc Interv. 2024 Dec;17(12):e014251. doi: 10.1161/CIRCINTERVENTIONS.124.014251. Epub 2024 Dec 17.
PubMed 39689189Van de Werf F, Ristic AD, Averkov OV, Arias-Mendoza A, Lambert Y, Kerr Saraiva JF, Sepulveda P, Rosell-Ortiz F, French JK, Music LB, Vandenberghe K, Bogaerts K, Westerhout CM, Pages A, Danays T, Bainey KR, Sinnaeve P, Goldstein P, Welsh RC, Armstrong PW; STREAM-2 Investigators. STREAM-2: Half-Dose Tenecteplase or Primary Percutaneous Coronary Intervention in Older Patients With ST-Segment-Elevation Myocardial Infarction: A Randomized, Open-Label Trial. Circulation. 2023 Aug 29;148(9):753-764. doi: 10.1161/CIRCULATIONAHA.123.064521. Epub 2023 Jul 13.
PubMed 37439219