STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction

STATUS

Recruiting
End date

Oct 9, 2022
participants needed

600
sponsor

KU Leuven

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Updated on 9 August 2021

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Katleen Vandenberghe, PhD

Primary Contact

Hospital Gea Gonzalez (3.5 mi away) Contact

+51 other location

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 Identifier	NCT02777580
Sponsor	KU Leuven
Last Modified on	9 August 2021

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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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STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction

Katleen Vandenberghe, PhD

Hospital Gea Gonzalez (3.5 mi away) Contact