STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction

Myocardial Infarction Clinical Trial

— STREAM-2  

Official title:

STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02777580
• Other study ID #: LRD.2016.STREAM2
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 1, 2017
• Est. completion date: October 2023

Study information

• Verified date: December 2022
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 609
• Est. completion date: October 2023
• Est. primary completion date: October 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Tenecteplase
Half dose Tenecteplase
• 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.

Procedure:
• Coronary angiography
Coronary angiography followed by PCI or CABG if required, rescue PCI if required
• Primary PCI
Primary PCI accoring to local standards

Locations

Country	Name	City	State
Australia	Liverpool Hospital - Cardiology Department	Liverpool
Brazil	Centro de Pesquisa São Lucas - Hospital E Maternidade Celso Pierro	Campinas
Canada	University of Alberta Hospital	Edmonton	Alberta
Chile	Hospital Regional de Antofagasta	Antofagasta
Chile	Hospital Comunitario de Mejillones	Mejillones
Chile	Hospital de Melipilla	Melipilla
Chile	Hospital Regional de Rancagua	Rancagua
Chile	SAR Rancagua	Rancagua
Chile	Hospital San Juan de Dios	Santiago
Chile	Hospital de Talagante	Talagante
Chile	Hospital de Tocopilla	Tocopilla
France	CH Louis Pradel - Hospices civils de Lyon	Bron
France	CH Cahors - SAMU 46	Cahors
France	CH de Chateauroux	Châteauroux
France	CH Sud Francilien - Service Cardiologie	Corbeil-Essonnes
France	Centre Hospitalier de Versailles	Le Chesnay
France	CHRU de Lille	Lille
France	CH St. Joseph - St Luc - Lyon	Lyon
France	Groupe Hospitalier Sud Ile de France - CH de Melun - Service SAMU 77	Melun
France	Clinque du Pont de Chaume	Montauban
France	CHU de Rennes	Rennes
France	CH Lucien Hussel	Vienne
Mexico	Hospital Gea Gonzalez	Mexico City
Mexico	Instituto Nacional de Cardiologia Ignacio Chavez	Mexico City
Montenegro	JZU Blazo Orlandic	Bar
Montenegro	General Hospital Danilo the First Cetinje	Cetinje
Montenegro	General Hospital of Niksic	Nikšic
Montenegro	Clinical Centar of Montenegro	Podgorica
Russian Federation	Federal State Budgetary Inst "Research Inst. for Complex Issues of Card. Diseases"	Kemerovo
Russian Federation	State Budgetary Healthcare Inst. Kemerovo-Clinical Emergency Care Station	Kemerovo
Russian Federation	Federal State Budgetary Scientific Inst "Tomsk Nat Research Med.Center of Russian Academy Sciences"	Tomsk
Russian Federation	Tomsk Regional State Autonomous Healthcare Institution Emergency Care Station	Tomsk
Russian Federation	State Budgetary Healthcare Institution of Tverskoy Region "Region Clinical Hospital"	Tver
Russian Federation	Tver Region State Budgetary Healthcare Institution "Tver Emergency Station"	Tver
Serbia	General Hospital "Dr. Laza K. Lazarevic" Sabac, Internal medicine department	Šabac
Serbia	Clinical Center of Serbia, Cardiology Clinic	Belgrade
Serbia	Institute for cardiovascular diseases Dedinje, Cardiovascular research sector	Belgrade
Serbia	Military Medical Academy, Clinic for Emergency Internal Medicine	Belgrade
Serbia	General Hospital Cuprija, Cardiology Department	Cuprija
Serbia	General Hospital Jagodina/Intenal Medicine department	Jagodina
Serbia	Clinical Center Kragujevac, Cardiology Clinic	Kragujevac
Serbia	General Hospital Pancevo/Department of internal medicine - cardiology section	Pancevo
Serbia	General Hospital "Sveti Luka" Smederevo, Dept of Internal Med - Cardiology Section	Smederevo
Serbia	Institute for cardiovascular diseases Vojvodina - Sremska Kamenica, Cardiology Clinic	Sremska Kamenica
Serbia	General Hospital Vrsac/Cardiology department with coronary unit	Vršac
Serbia	Opsta bolnica Vrbas, Cardiology Department	Vrbas
Spain	Hospital Comarcal Axarquia, Unidad de Cuidados Intensivos	Málaga
Spain	Hospital de Antequera, Unidad de Cuidados Intensivos	Málaga
Spain	Hospital Serrania Ronda, Unidad de Cuidados Intensivos	Málaga
Spain	Hospital Virgen de la Victoria, Unidad de Cuidados Intensivos	Málaga

Sponsors (4)

Lead Sponsor	Collaborator
KU Leuven	Boehringer Ingelheim, Fund for Clinical Cardiovascular Research at LRD, Life Sciences Research Partners

Countries where clinical trial is conducted

Australia,  Brazil,  Canada,  Chile,  France,  Mexico,  Montenegro,  Russian Federation,  Serbia,  Spain, 

References & Publications (4)

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. — View Citation

Dianati 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. — View Citation

Sinnaeve 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. — View Citation

Sinnaeve 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		30 days
Primary	Number of patients with stroke (total, intracranial haemorrhage, ischaemic, haemorrhagic conversion) and non-intracranial bleeds. Number of patients with serious cardiac events.	Serious cardiac events (e.g. death , congestive heart failure, reinfarction, resuscitated ventricular fibrillation, repeat target vessel recanalization, stent thrombosis, total AV block etc).	30 days
Primary	Composite endpoints (e.g. death, shock, heart failure and recurrent MI) will be assessed as described in the statistical analytical plan.		30 days