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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Mr Alexis Wallace
+1 617 2307439
awallace@tsillc.net


Dr Vasim Farooq
+44 7968715797
Vasim.Farooq@wales.nhs.uk


Study Location:

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Be Part of Research - Trial Details - 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
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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

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Open to: All Genders

Age: Adult

Pontyclun Cardiff Merthyr Tydfil

Medical Conditions

Participants presenting with ST-elevation myocardial infarction

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Heart attacks are the end result of a blockage of an artery of the heart, and according to the World Health Organisation, heart attacks are one of the leading causes of death worldwide. This study concerns a type of heart attack called STEMI. The treatment of a patient who has suffered a heart attack, as quickly as possible, gives them the best chance of survival and recovery from their heart attack. One of the main treatments is a PCI (primary percutaneous coronary intervention) which is a way of inserting a tube (stent) into the blocked artery or a balloon into the blocked artery or other mechanical means to help restore the blood flow through the blocked artery quickly. Delays in receiving this treatment and/or being transferred to a hospital where this treatment can be performed has a negative impact on the outcome for patients suffering a heart attack. If a patient suffering a heart attack arrives at a hospital that cannot perform PCI then a treatment called fibrinolysis is recommended. Fibrinolysis breaks down the clot that has caused the blockage but is limited by possible bleeding issues for the patient. Previous studies have indicated that a treatment called “sequential fibrinolysis therapy” has the potential to be safer. This is giving two fibrinolysis treatments one after another. Thrombolytic Science LLC, a US based company, have developed HisproUK which is a fibrinolytic medication, meaning that it is a treatment used to dissolve blood clots. The aim of this study is to assess the safety and effectiveness of “sequential fibrinolysis” (a low dose of a fibrinolysis drug called alteplase by injection followed by an infusion into the patient’s vein of HisproUK).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

10 Oct 2024 30 Nov 2025

The study will compare patients treated with the “sequential fibrinolysis therapy” with patients who receive the normal standard care.


Patients who have suffered a heart attack and are also expected to have a delay of at least 1 hour before being able to receive the PCI treatment.

You can take part if:



You may not be able to take part if:


1. Left bundle branch block (LBBB) or ventricular pacing2. 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 months5. Known contraindications to primary PCI or cardiac MRI6. Cardiogenic shock (Killip Class IV)7. NYHA Class 3-4 heart failure8. History of intracranial haemorrhage9. Known intolerance/hypersensitivity to aspirin, ticagrelor, heparin, limus drugs10. 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 bivalirudin12. Severe hepatic impairment13. Non-cardiac co-morbidity with expected survival <1 year14. 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


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal Glamorgan Hospital
    Ynysmaerdy
    Pontyclun
    CF72 8XR
  • Cardiff ECMC
    Cardiff University University Hospital of Wales Heath Park
    Cardiff
    CF14 4XN
  • Prince Charles Hospital Site
    Prince Charles Hospital
    Merthyr Tydfil
    CF47 9DT

The anticipated clinical benefits are:
- Improved myocardial salvage
- Limited infarct size
- Improved patient outcomes
Risks:
Adverse events noted in a phase I, randomised, double blind, healthy volunteer trial in 26 healthy male volunteers who received a single dose of HisproUK or placebo intravenously or a single dose of HisproUK or placebo preceded by a single mini bolus of tPA predominantly included mild and moderate gastro-intestinal disturbances. Adverse events included:
• Diarrhoea
• Nausea
• Vomiting
• Abdominal discomfort
• Blood fibrinogen decreased (0.7 g/L) at 50 mg mproUK
• Nausea and pyrexia (same subject) at 50 mg mproUK
• Syncope, which occurred during an episode of vomiting at 65 mg mproUK
• Leukocytosis in one patient that received 50 mg mproUK on Day 1 of receiving study drug.
No residual risks have been identified from the healthy volunteer trial. For this trial all adverse events will be collected and reviewed by the DSMB but events of note will be related to bleeding events, ischaemic events such as stroke, and measures of changes in fibrinogen (a measure of systemic fibrinolysis – depletion will increase the risk of bleeding) and fibrin D-dimer (fibrin degradation product – a measure of fibrin lysis and therefore efficacy of the drug).
There is extensive clinical and commercial experience worldwide with cardiac catheterization and interventional procedures and it is expected that the procedural risks in this study and existing stenting procedure will not be significantly different. No additional discomfort is anticipated other than the risks described by the clinical professional ahead of the PCI procedure before enrolment into the trial.
Known adverse events that may result from stent intervention include, but may not be limited to:
• Allergic reaction or hypersensitivity to device material and its degredants (everolimus, platinum, chromium, poly-lactide-co-glycolide (PLGA))
• Shortness of breath/dyspnea
• Distal embolism (air, tissue, or thrombotic)
• Nausea/Vomiting
• Coronary and stent thrombosis
• Coronary and stent embolism
• Coronary dissection
• Total coronary occlusion
• Abrupt coronary closure/threatened abrupt closure
• Coronary injury
• Coronary spasm
• Coronary perforation
• Coronary rupture
• Pseudoaneurysm
• Angina (stable or unstable)
• Urgent or non-urgent coronary artery bypass graft surgery
• Vascular complications including at the entry site which may require vessel repair and vessel dissection
• Hematoma
• Respiration cease
• Hypertension
• Death
• Bleeding
• Bleeding complication (that may require transfusion)
• Shock
• Myocardial ischemia
• Cardiac enzyme level elevation
• Myocardial infarction
• Cardiac tamponade
• Cardiac arrest
• ECG change
• Heart failure
• Renal failure
• Stent implanted in unintended location
• Restenosis of lesion/vessel treated with stent
• Access site infection or pain
• Access site hematoma or bleeding
• Cerebral stroke/cerebral vascular accident (CV A)
• Hypotension
• Palpitation
• Aneurysm
• Arteriovenous fistula
• Pulmonary edema
• Fever
• Arrhythmia (atrial or ventricular)
• Peripheral ischemia (due to vascular injury)
• Adverse reaction to drug (to everolimus, antiplatelets or contrast agent)
At the end of the primary PCI procedure, a coronary physiology study is carried out for the study. The drugs administered during the coronary physiology study (nitrates and adenosine) may induce transient low blood pressure, low heart rate, headaches which will likely clear up without requiring further treatment.
Patients will be required to be transferred from a non-PCI hospital to a PCI hospital, whilst receiving the IMP via infusion in the ambulance. In order to minimise risk during the transfer, ambulance teams will be provided with the details of back-up medics who can be contact in the case of any adverse events.
We anticipate minimal burden for participating in the trial but acknowledge participants are being asked to attend one additional hospital visit, to have two MRI scans, to complete a medication diary, and to complete 3 questionnaires at the follow up visit. The visits outside of usual care will be organised by the research nurse and completion of the questionnaires will also be supported by the research team.

Mr Alexis Wallace
+1 617 2307439
awallace@tsillc.net


Dr Vasim Farooq
+44 7968715797
Vasim.Farooq@wales.nhs.uk



The study is sponsored by Thrombolytic Science LLC and funded by Thrombolytic Science LLC.



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Read full details for Trial ID: ISRCTN14164179

Or CPMS 54066

Last updated 06 March 2025

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