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Clinical Trials/ISRCTN14164179
ISRCTN14164179Active, not recruitingPhase 2

An open-label, randomised study to evaluate the safety and efficacy of sequential 'physiological' fibrinolysis with mutant pro-urokinase and low-dose alteplase to establish early epicardial and microvessel patency in patients presenting with an ST-elevation myocardial infarction with an expected delay of at least one hour before undergoing mechanical reperfusion at a PCI-capable hospital

Thrombolytic Science LLC0 sites48 target enrollmentStarted: December 27, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Active, not recruiting
Sponsor
Enrollment
48
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Presentation to an investigational site with an acute ST-elevation myocardial infarction (symptom onset 0-6 h) requiring mechanical reperfusion with primary PCI to one or more lesions
  • •2. Visually assessed ST-segment elevation (measured at the J-point) in at least two contiguous leads with ST-segment elevation. = 2.5 mm in men <40 years; =2 mm in men =40 years = 1.5 mm in women in leads V2–V3 and/or = 1 mm in the other leads In the absence of left ventricular hypertrophy or left bundle branch block (LBBB) and associated with ongoing ischaemic symptoms
  • •3. Aged =18 years
  • •4. Anticipated delay to primary PCI of at least 1 hour from presentation to being able to be treated with emergency mechanical reperfusion at a PCI-capable centre
  • •5. Able in person, or with the support of a Next of Kin or legal guardian, to provide informed verbal assent prior to randomisation.
  • •6. Radial artery access for primary PCI procedure

Exclusion Criteria

  • •1. Left bundle branch block (LBBB) or ventricular pacing
  • •2. Currently taking a P2Y12 inhibitor (clopidogrel, ticagrelor or prasugrel)
  • •3. High bleeding risk patients – one major, or two minor criteria on the ARC-HBR criteria
  • •4. Prior percutaneous coronary intervention in the last 3 months
  • •5. Known contraindications to primary PCI or cardiac MRI
  • •6. Cardiogenic shock (Killip Class IV)
  • •7. NYHA Class 3-4 heart failure
  • •8. History of intracranial haemorrhage
  • •9. Known intolerance/hypersensitivity to aspirin, ticagrelor, heparin, limus drugs
  • •10. Patients with current concomitant oral anticoagulant therapy, including vitamin K antagonists (warfarin) and non-vitamin K antagonist oral anticoagulants (NOACS)
  • •11. Recent administration of any intravenous or subcutaneous anticoagulation within 12 h, including unfractionated heparin, enoxaparin, and/or bivalirudin
  • •12. Severe hepatic impairment
  • •13. Non-cardiac co-morbidity with expected survival <1 year
  • •14. Patients of child-bearing potential with either a confirmed positive pregnancy test or those unable to have a pregnancy test conducted prior to inclusion in the study

Investigators

Sponsor
Thrombolytic Science LLC

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