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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Boehringer Ingelheim
Life Sciences Research Partners
Fund for Clinical Cardiovascular Research at LRD
Information provided by (Responsible Party):
Frans Van de Werf, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT02777580
First received: May 13, 2016
Last updated: May 8, 2017
Last verified: May 2017
  Purpose
In elderly patients ≥ 70yrs 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.

Condition Intervention Phase
Myocardial Infarction Drug: Tenecteplase Drug: Clopidogrel Procedure: Coronary angiography Procedure: Primary PCI Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Frans Van de Werf, Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • 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 ]

Enrollment: 600
Actual Study Start Date: May 8, 2017
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Active Comparator: Standard primary PCI
Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
Procedure: Primary PCI
Primary PCI accoring to local standards

  Eligibility

Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age equal or greater than 70 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02777580

Locations
France
CH de Chateauroux
Châteauroux, France, 36019
Centre Hospitalier de Versailles
Le Chesnay, France, 78157
CHRU de Lille
Lille, France, 59037
Sponsors and Collaborators
Katholieke Universiteit Leuven
Boehringer Ingelheim
Life Sciences Research Partners
Fund for Clinical Cardiovascular Research at LRD
Investigators
Study Chair: Frans Van de Werf, MD, PhD Katholieke Universiteit 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
  More Information

Publications:

Responsible Party: Frans Van de Werf, Prof Dr, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT02777580     History of Changes
Other Study ID Numbers: LRD.2016.STREAM2
Study First Received: May 13, 2016
Last Updated: May 8, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Frans Van de Werf, Katholieke Universiteit Leuven:
Thrombolytic Therapy
Primary PCI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Tenecteplase
Tissue Plasminogen Activator
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents

ClinicalTrials.gov processed this record on June 23, 2017