STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction

  • STATUS
    Recruiting
  • End date
    Oct 9, 2022
  • participants needed
    600
  • sponsor
    KU Leuven
Updated on 9 August 2021
angiography
aspirin
myocardial infarction
stemi
infarct
clopidogrel
antiplatelet therapy
st elevation myocardial infarction
tenecteplase
reperfusion therapy

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.

Details
Condition Myocardial Infarction, Heart Attack (Myocardial Infarction), Ischemic Heart Disease, Cardiac Ischemia, cardiac infarction, myocardial infarction (mi), heart attacks, heart attack, myocardial necrosis, Myocardial Ischemia
Treatment Clopidogrel, Coronary Angiography, Tenecteplase, Primary PCI
Clinical Study IdentifierNCT02777580
SponsorKU Leuven
Last Modified on9 August 2021

Eligibility

Yes No Not Sure

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)
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
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
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