A study to test the safety and effectiveness of using mutant pro-urokinase and low-dose alteplase to unblock blood vessels in heart attack patients before receiving treatment at a hospital with PCI capability
- Conditions
- Participants presenting with ST-elevation myocardial infarctionCirculatory System
- Registration Number
- ISRCTN14164179
- Lead Sponsor
- Thrombolytic Science LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 48
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline serum fibrinogen levels to 6 h after administration of the IMP
- Secondary Outcome Measures
Name Time Method