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OpenTrials
Completed

NCT Number: NCT02777580

STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Liverpool Hospital - Cardiology Department, Liverpool, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tenecteplase

Drug

Half dose Tenecteplase

Other names: TNKase, Metalyse

clopidogrel

Drug

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.

Coronary Angiography

Procedure

Coronary angiography followed by PCI or CABG if required, rescue PCI if required

Primary PCI

Procedure

Primary PCI accoring to local standards

Primary outcomes

  1. Successful Reperfusion

    Time frame: 30 min post angiogram/PCI

    Worst-lead ST-segment elevation resolution ≥ 50% 30 min post angiogram/PCI

  2. Composite Clinical Efficacy End Point: All Cause Death, Shock, CHF and Reinfarction at 30 Days

    Time frame: 30 days

  3. Total Stroke

    Time frame: 30 days

    Number of patients with stroke (intracranial haemorrhage, ischaemic, haemorrhagic conversion)

  4. Major Non-intrancranial Bleedings

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Boehringer Ingelheim
  • Frans Van de Werf Fund for Clinical Cardiovascular Research
  • Life Sciences Research Partners

Registry information

Acronym: STREAM-2

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
May 19, 2016
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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