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)

Liverpool Hospital - Cardiology Department; 🇦🇺 Liverpool, Australia

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

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

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

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