Clinical Accelerator, a full-service contract research organization, has entered into a collaboration with Thrombolytic Science International (TSI) to conduct a phase II randomised, multi-centre, open-label, parallel group mechanistic study using TSI’s dual treatment regimen in patients with ST elevation myocardial infarction (STEMI).
The purpose of this clinical trial is to affirm the safety and efficacy of sequential thrombolytic therapy with mutant pro-urokinase and low dose tissue plasminogen activator (tPA) as a potentially safe, simple and early reperfusion treatment for STEMI in comparison with standard of care percutaneous coronary intervention.
TSI’s thrombolytic treatment regimen is based on the endogenous human fibrinolytic system. It uses a low dose of tPA, the approved thrombolytic agent, followed by mutant pro-urokinase, a more stable and safer version of well-studied thrombolytic, pro-urokinase (proUK).
The dual regimen concept was validated in the phase II trial PATENT trial, which showed that a dual treatment of tPA and proUK was more effective and safer than either activator alone.
This novel treatment with mutant proUK is based on the pioneering work of Dr Victor Gurewich, Professor of Medicine at Harvard Medical School, a researcher and a TSI co-founder.