STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction

Phase 4

Completed

• Conditions: Myocardial Infarction
• Interventions: Procedure: Primary PCI; Drug: Tenecteplase; Drug: Clopidogrel; Procedure: Coronary angiography

• Registration Number: NCT02777580
• Lead Sponsor: KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-13
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-19
• Study Start: 2017-08-01
• Primary Completion: 2022-10-13
• Study Completion: 2023-09-30
• Results First Submitted: 2024-01-23
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-09
• Last Update Submitted: 2024-07-09
• Results First Posted: 2024-10-04
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 609

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmaco-invasive strategy	Coronary angiography	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.
Pharmaco-invasive strategy	Clopidogrel	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.
Standard primary PCI	Primary PCI	Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
Pharmaco-invasive strategy	Tenecteplase	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.

Primary Outcome Measures

Name	Time	Method
Successful Reperfusion	30 min post angiogram/PCI	Worst-lead ST-segment elevation resolution ≥ 50% 30 min post angiogram/PCI
Composite Clinical Efficacy End Point: All Cause Death, Shock, CHF and Reinfarction at 30 Days	30 days
Total Stroke	30 days	Number of patients with stroke (intracranial haemorrhage, ischaemic, haemorrhagic conversion)
Major Non-intrancranial Bleedings	30 days

Trial Locations

Locations (50)

Hospital de Tocopilla; 🇨🇱 Tocopilla, Chile

Hospital Regional de Antofagasta; 🇨🇱 Antofagasta, Chile

Institute for cardiovascular diseases Dedinje, Cardiovascular research sector; 🇷🇸 Belgrade, Serbia

General Hospital of Niksic; 🇲🇪 Nikšić, Montenegro

General Hospital Pancevo/Department of internal medicine - cardiology section; 🇷🇸 Pančevo, Serbia

Opsta bolnica Vrbas, Cardiology Department; 🇷🇸 Vrbas, Serbia

JZU Blazo Orlandic; 🇲🇪 Bar, Montenegro

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

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

General Hospital Vrsac/Cardiology department with coronary unit; 🇷🇸 Vršac, Serbia

General Hospital Danilo the First Cetinje; 🇲🇪 Cetinje, Montenegro

Clinical Centar of Montenegro; 🇲🇪 Podgorica, Montenegro

Hospital Comunitario de Mejillones; 🇨🇱 Mejillones, Chile

Hospital Regional de Rancagua; 🇨🇱 Rancagua, Chile

Liverpool Hospital - Cardiology Department; 🇦🇺 Liverpool, Australia

Hospital de Melipilla; 🇨🇱 Melipilla, Chile

SAR Rancagua; 🇨🇱 Rancagua, Chile

CH Cahors - SAMU 46; 🇫🇷 Cahors, 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, France

Federal State Budgetary Inst "Research Inst. for Complex Issues of Card. Diseases"; 🇷🇺 Kemerovo, Russian Federation

Hospital San Juan de Dios; 🇨🇱 Santiago, Chile

Hospital de Talagante; 🇨🇱 Talagante, Chile

CH de Chateauroux; 🇫🇷 Châteauroux, France

Tomsk Regional State Autonomous Healthcare Institution Emergency Care Station; 🇷🇺 Tomsk, Russian Federation

CHRU de Lille; 🇫🇷 Lille, France

State Budgetary Healthcare Institution of Tverskoy Region "Region Clinical Hospital"; 🇷🇺 Tver, Russian Federation

Clinical Center of Serbia, Cardiology Clinic; 🇷🇸 Belgrade, Serbia

General Hospital "Sveti Luka" Smederevo, Dept of Internal Med - Cardiology Section; 🇷🇸 Smederevo, Serbia

General Hospital Cuprija, Cardiology Department; 🇷🇸 Cuprija, Serbia

Hospital Virgen de la Victoria, Unidad de Cuidados Intensivos; 🇪🇸 Málaga, Spain

General Hospital Jagodina/Intenal Medicine department; 🇷🇸 Jagodina, Serbia

Clinical Center Kragujevac, Cardiology Clinic; 🇷🇸 Kragujevac, Serbia

General Hospital "Dr. Laza K. Lazarevic" Sabac, Internal medicine department; 🇷🇸 Šabac, Serbia

Hospital de Antequera, Unidad de Cuidados Intensivos; 🇪🇸 Málaga, Spain

Hospital Serrania Ronda, Unidad de Cuidados Intensivos; 🇪🇸 Málaga, Spain

Hospital Comarcal Axarquia, Unidad de Cuidados Intensivos; 🇪🇸 Málaga, Spain

Centro de Pesquisa São Lucas - Hospital E Maternidade Celso Pierro; 🇧🇷 Campinas, Brazil

Hospital Gea Gonzalez; 🇲🇽 Mexico City, Mexico

CH Louis Pradel - Hospices civils de Lyon; 🇫🇷 Bron, France

CH Sud Francilien - Service Cardiologie; 🇫🇷 Corbeil-Essonnes, France

Centre Hospitalier de Versailles; 🇫🇷 Le Chesnay, France

CH St. Joseph - St Luc - Lyon; 🇫🇷 Lyon, France

Instituto Nacional de Cardiologia Ignacio Chavez; 🇲🇽 Mexico City, Mexico

Tver Region State Budgetary Healthcare Institution "Tver Emergency Station"; 🇷🇺 Tver, Russian Federation

Military Medical Academy, Clinic for Emergency Internal Medicine; 🇷🇸 Belgrade, Serbia

Institute for cardiovascular diseases Vojvodina - Sremska Kamenica, Cardiology Clinic; 🇷🇸 Sremska Kamenica, Serbia