Last updated on February 2020

STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Myocardial Infarction | Ischemic Heart Disease | Cardiac Ischemia | Myocardial Ischemia | Heart Attack (Myocardial Infarction)
  • Age: Between 60 - 100 Years
  • Gender: Male or Female

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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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