STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction

Study Overview
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Brief Summary
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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.

Official Title
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STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: Tenecteplase
* Drug: Clopidogrel
* Procedure: Coronary angiography
* Procedure: Primary PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmaco-invasive strategy<br>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. | Drug: Tenecteplase<br>* Half dose Tenecteplase<br>* Other names: Metalyse;Drug: Clopidogrel<br>* 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.<br>Procedure: Coronary angiography<br>* Coronary angiography followed by PCI or CABG if required, rescue PCI if required<br>|
| Active Comparator: Standard primary PCI<br>Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards. | Procedure: Primary PCI<br>* Primary PCI accoring to local standards<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Composite endpoints (e.g. death, shock, heart failure and recurrent MI) will be assessed as described in the statistical analytical plan. |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary PCI, Thrombolytic Therapy