Linyi

Researchers are conducting a Phase 3 clinical trial to evaluate the safety and effectiveness of WS016 for treating hyperkalemia, a condition characterized by high potassium levels in the blood. The trial includes adults aged 18 years and older with serum potassium levels between 5.0 and 6.5 mmol/L. The study consists of two parts: Part A is a randomized, double-blind, placebo-controlled trial, and Part B is an open-label extension for eligible participants from Part A. In Part A, participants are first randomly assigned in a 5:1 ratio to receive either oral WS016 at a 12g dose or a placebo three times a day for 48 hours, totaling six doses. Following this corrective phase, those with normal potassium levels are re-randomized into one of four groups to receive WS016 at 6g, 12g, or 18g, or placebo once daily for 28 days. Participants who finish or discontinue Part A due to potassium level changes and meet eligibility criteria can join Part B, receiving WS016 once daily for 11 months. The dose in Part B starts at 12g and may be adjusted based on ongoing potassium monitoring. Throughout the study, researchers measure serum potassium levels, focusing on average levels during the 28-day maintenance phase. Participants will undergo regular blood tests and health assessments to monitor potassium and overall safety. The study also includes tracking any side effects and adjusting treatment as needed. The total duration for participants entering Part B may extend up to nearly a year, including the initial phases and the long-term extension.

Researchers are evaluating the safety and effectiveness of starting direct oral anticoagulants (DOACs) early versus later in patients who have acute ischemic stroke related to atrial fibrillation and who have undergone emergency endovascular therapy (EVT). This multicenter, prospective, open-label randomized controlled trial focuses on different timings to begin DOAC therapy to improve outcomes and reduce risks after stroke. Patients will be randomly assigned to one of two groups: the early anticoagulation group, which starts DOACs within four days of symptom onset, and the delayed anticoagulation group, which begins DOACs between 5 and 14 days after symptom onset. The study observes these treatment timings after emergency EVT for stroke, assessing their effects on patient safety and stroke recurrence. Participants will be monitored closely for 90 days after treatment to assess outcomes including recurrent ischemic stroke, symptomatic intracranial hemorrhage, and death from any cause. Evaluations include clinical assessments and imaging such as CT or MRI to detect hemorrhagic changes. Researchers will also review medical history, stroke severity, and treatment adherence. The study involves follow-up visits and data collection to ensure thorough safety and efficacy analysis over the three-month period.