Clinical trial NCT02777580: STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction
Official title: STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Keywords: Thrombolytic Therapy
Primary PCI
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
name: Life Sciences Research Partners
name: Frans Van de Werf Fund for Clinical Cardiovascular Research
First posted: 2016-05-19
Enrollment: 609
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Successful Reperfusion
timeFrame: 30 min post angiogram/PCI
measure: Composite Clinical Efficacy End Point: All Cause Death, Shock, CHF and Reinfarction at 30 Days
timeFrame: 30 days
measure: Total Stroke
timeFrame: 30 days
measure: Major Non-intrancranial Bleedings
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: Australia
facility: Liverpool Hospital - Cardiology Department
city: Campinas
country: Brazil
facility: Centro de Pesquisa São Lucas - Hospital E Maternidade Celso Pierro
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Antofagasta
country: Chile
facility: Hospital Regional de Antofagasta
city: Mejillones
country: Chile
facility: Hospital Comunitario de Mejillones
city: Melipilla
country: Chile
facility: Hospital de Melipilla
city: Rancagua
country: Chile
facility: Hospital Regional de Rancagua
city: Rancagua
country: Chile
facility: SAR Rancagua
city: Santiago
country: Chile
facility: Hospital San Juan de Dios
city: Talagante
country: Chile
facility: Hospital de Talagante
city: Tocopilla
country: Chile
facility: Hospital de Tocopilla
city: Bron
country: France
facility: CH Louis Pradel - Hospices civils de Lyon
city: Cahors
country: France
facility: CH Cahors - SAMU 46
city: Châteauroux
country: France
facility: CH de Chateauroux
city: Corbeil-Essonnes
country: France
facility: CH Sud Francilien - Service Cardiologie
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles
city: Lille
country: France
facility: CHRU de Lille
city: Lyon
country: France
facility: CH St. Joseph - St Luc - Lyon
city: Melun
country: France
facility: Groupe Hospitalier Sud Ile de France - CH de Melun - Service SAMU 77
city: Montauban
country: France
facility: Clinque du Pont de Chaume
city: Rennes
country: France
facility: CHU de Rennes
city: Vienne
country: France
facility: CH Lucien Hussel
city: Mexico City
country: Mexico
facility: Hospital Gea Gonzalez
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cardiologia Ignacio Chavez
city: Bar
country: Montenegro
facility: JZU Blazo Orlandic
city: Cetinje
country: Montenegro
facility: General Hospital Danilo the First Cetinje
city: Nikšić
country: Montenegro
facility: General Hospital of Niksic
city: Podgorica
country: Montenegro
facility: Clinical Centar of Montenegro
city: Kemerovo
country: Russian Federation
facility: Federal State Budgetary Inst "Research Inst. for Complex Issues of Card. Diseases"
city: Kemerovo
country: Russian Federation
facility: State Budgetary Healthcare Inst. Kemerovo-Clinical Emergency Care Station
city: Tomsk
country: Russian Federation
facility: Federal State Budgetary Scientific Inst "Tomsk Nat Research Med.Center of Russian Academy Sciences"
city: Tomsk
country: Russian Federation
facility: Tomsk Regional State Autonomous Healthcare Institution Emergency Care Station
city: Tver
country: Russian Federation
facility: State Budgetary Healthcare Institution of Tverskoy Region "Region Clinical Hospital"
city: Tver
country: Russian Federation
facility: Tver Region State Budgetary Healthcare Institution "Tver Emergency Station"
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia, Cardiology Clinic
city: Belgrade
country: Serbia
facility: Military Medical Academy, Clinic for Emergency Internal Medicine
city: Belgrade
country: Serbia
facility: Institute for cardiovascular diseases Dedinje, Cardiovascular research sector
city: Cuprija
country: Serbia
facility: General Hospital Cuprija, Cardiology Department
city: Jagodina
country: Serbia
facility: General Hospital Jagodina/Intenal Medicine department
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac, Cardiology Clinic
city: Pančevo
country: Serbia
facility: General Hospital Pancevo/Department of internal medicine - cardiology section
city: Smederevo
country: Serbia
facility: General Hospital "Sveti Luka" Smederevo, Dept of Internal Med - Cardiology Section
city: Sremska Kamenica
country: Serbia
facility: Institute for cardiovascular diseases Vojvodina - Sremska Kamenica, Cardiology Clinic
city: Vrbas
country: Serbia
facility: Opsta bolnica Vrbas, Cardiology Department
city: Vršac
country: Serbia
facility: General Hospital Vrsac/Cardiology department with coronary unit
city: Šabac
country: Serbia
facility: General Hospital "Dr. Laza K. Lazarevic" Sabac, Internal medicine department
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria, Unidad de Cuidados Intensivos
city: Málaga
country: Spain
facility: Hospital de Antequera, Unidad de Cuidados Intensivos
city: Málaga
country: Spain
facility: Hospital Serrania Ronda, Unidad de Cuidados Intensivos
city: Málaga
country: Spain
facility: Hospital Comarcal Axarquia, Unidad de Cuidados Intensivos
Study officials:
affiliation: KU Leuven
name: Frans Van de Werf, MD, PhD
role: STUDY_CHAIR
affiliation: University of Alberta, Edmonton, Canada
name: Paul Armstrong, MD
role: STUDY_CHAIR
affiliation: UZ Leuven, Belgium
name: Peter Sinnaeve, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta, Edmonton, Canada
name: Robert Welsh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lille University Hospital, France
name: Patrick Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.