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STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction (STREAM-2)

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ClinicalTrials.gov Identifier: NCT02777580
Recruitment Status : Recruiting
First Posted : May 19, 2016
Last Update Posted : November 9, 2018
Sponsor:
Collaborators:
Boehringer Ingelheim
Life Sciences Research Partners
Fund for Clinical Cardiovascular Research at LRD
Information provided by (Responsible Party):
Frans Van de Werf, KU Leuven

Tracking Information
First Submitted Date  ICMJE May 13, 2016
First Posted Date  ICMJE May 19, 2016
Last Update Posted Date November 9, 2018
Actual Study Start Date  ICMJE August 1, 2017
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2016)
  • 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. [ Time Frame: 30 days ]
  • Number of patients with stroke (total, intracranial haemorrhage, ischaemic, haemorrhagic conversion) and non-intracranial bleeds. Number of patients with serious cardiac events. [ Time Frame: 30 days ]
    Serious cardiac events (e.g. death , congestive heart failure, reinfarction, resuscitated ventricular fibrillation, repeat target vessel recanalization, stent thrombosis, total AV block etc).
  • Composite endpoints (e.g. death, shock, heart failure and recurrent MI) will be assessed as described in the statistical analytical plan. [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 17, 2016)
  • Number of patients achieving ≥ 50 % ST-segment resolution before and after PCI in lead with maximal ST elevation at baseline; % rescue PCI; TIMI flow grades [ Time Frame: 30 days ]
  • Total stroke, intracranial haemorrhage, ischaemic stroke, haemorrhagic conversion. Non-intracranial bleeds. Serious cardiac events. [ Time Frame: 30 days ]
    Serious cardiac events (e.g. death , congestive heart failure, reinfarction, resuscitated ventricular fibrillation, repeat target vessel recanalization, stent thrombosis, total AV block etc).
  • Death, shock, heart failure, recurrent MI and aborted MI will be recorded and assessed as single or composite endpoints for evaluation as noted in the statistical analytical plan. [ Time Frame: 30 days ]
Change History Complete list of historical versions of study NCT02777580 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction
Official Title  ICMJE STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction
Brief Summary In elderly 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE
  • Drug: Tenecteplase
    Half dose Tenecteplase
    Other Names:
    • TNKase
    • Metalyse
  • Drug: Clopidogrel
    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.
  • Procedure: Coronary angiography
    Coronary angiography followed by PCI or CABG if required, rescue PCI if required
  • Procedure: Primary PCI
    Primary PCI accoring to local standards
Study Arms  ICMJE
  • Experimental: Pharmaco-invasive strategy
    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.
    Interventions:
    • Drug: Tenecteplase
    • Drug: Clopidogrel
    • Procedure: Coronary angiography
  • Active Comparator: Standard primary PCI
    Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
    Intervention: Procedure: Primary PCI
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 17, 2016)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Katleen Vandenberghe, PhD +3216342111 katleen.vandenberghe@uzleuven.be
Contact: Anne Luyten, MD +3216342111 anne.luyten@uzleuven.be
Listed Location Countries  ICMJE Canada,   Chile,   France,   Russian Federation,   Serbia,   Spain,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02777580
Other Study ID Numbers  ICMJE LRD.2016.STREAM2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Frans Van de Werf, KU Leuven
Study Sponsor  ICMJE KU Leuven
Collaborators  ICMJE
  • Boehringer Ingelheim
  • Life Sciences Research Partners
  • Fund for Clinical Cardiovascular Research at LRD
Investigators  ICMJE
Study Chair: Frans Van de Werf, MD, PhD KU Leuven
Study Chair: Paul Armstrong, MD University of Alberta, Edmonton, Canada
Principal Investigator: Peter Sinnaeve, MD, PhD UZ Leuven, Belgium
Principal Investigator: Robert Welsh, MD University of Alberta, Edmonton, Canada
Principal Investigator: Patrick Goldstein, MD Lille University Hospital, France
PRS Account KU Leuven
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP