SALVAGE_AMI
Research type
Research Study
Full title
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 a ST-elevation myocardial infarction with an expected delay of at least one hour before undergoing mechanical reperfusion at a PCI-capable hospital.
IRAS ID
1006643
Contact name
Alexis Wallace
Contact email
Sponsor organisation
Thrombolytic Science LLC
ISRCTN Number
ISRCTN14164179
Research summary
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) in 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. The study will compare patients treated with the “sequential fibrinolysis therapy” with patients who receive the normal standard care.
REC name
Wales REC 5
REC reference
23/WA/0225
Date of REC Opinion
22 Dec 2023
REC opinion
Further Information Favourable Opinion