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This research evaluates whether giving a half-dose bolus of recombinant staphylokinase (r-SAK) before primary percutaneous coronary intervention (PCI) improves outcomes in patients experiencing acute ST-segment elevation myocardial infarction (STEMI). STEMI is a serious heart condition caused by blocked coronary arteries leading to heart muscle damage. Early reperfusion treatment can reduce heart damage and improve prognosis, but it is unclear if adding thrombolytic therapy immediately before PCI within 120 minutes benefits patients. The study is a multicenter, randomized, double-blind, placebo-controlled Phase 4 trial comparing r-SAK to placebo in patients undergoing PCI within 120 minutes. Participants are randomly assigned to receive either an intravenous half-dose bolus of r-SAK or placebo within 10 minutes after STEMI diagnosis. The study focuses on facilitating PCI by potentially improving blood flow in blocked arteries through r-SAK's clot-dissolving action. The trial addresses challenges such as delays in transferring patients to PCI-capable hospitals and the risk of complications from high thrombus burden during stent placement. During the study, researchers will monitor participants for major adverse cardiovascular events (MACE) within 90 days. Assessments include clinical evaluations, ECGs, and safety monitoring to observe heart function and adverse effects. The total participation involves initial treatment and follow-up visits to track health status and treatment impact over three months.

Age: 18Years - 75YearsAll GendersPhase 4
61 locations
Clinical trials in Fuzhou | DecenTrialz