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Actively Recruiting

Researchers are evaluating the effectiveness of filgotinib in helping Korean adults with moderately to severely active ulcerative colitis reach clinical remission by Week 10 or 22. This phase 4, multi-center, open-label study focuses on patients who have not responded well to conventional or biologic therapies. The goal is to better understand filgotinib's role in routine clinical practice for this condition. Participants will receive filgotinib maleate as oral tablets at a dose of 200 mg. The study is a single-arm design, meaning all enrolled patients will be treated with filgotinib under normal clinical conditions. The treatment and observation occur over a period that includes assessments at Weeks 10 and 22 to evaluate remission status. During the study, participants will undergo assessments to monitor their health and disease activity, including evaluations based on the Mayo Clinic Score and endoscopy results. Researchers will also track safety and any side effects. The main outcome measured is the percentage of participants achieving clinical remission at Week 10 or 22. The study includes safety monitoring through regular visits and laboratory tests throughout the participation period.

Age: 19Years - 64YearsAll GendersPhase 4
19 locations
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Actively Recruiting

Researchers are evaluating the safety of a tailored antiplatelet therapy compared to a conventional strategy in patients with coronary artery disease who have received optimized drug-eluting stent (DES) implantation guided by intravascular imaging techniques such as IVUS or OCT. The study aims to determine if the tailored approach, which involves a shorter duration of dual antiplatelet therapy (DAPT) followed by P2Y12 inhibitor alone, reduces clinically relevant bleeding while being no worse than the conventional approach in terms of ischemic adverse events. This is a phase 4, prospective, open-label, multicenter, randomized trial involving 3,944 participants. Participants are randomly assigned to either the conventional DAPT strategy or the tailored antiplatelet strategy after optimized DES implantation confirmed by intravascular imaging. The tailored strategy involves short DAPT followed by P2Y12 inhibitor alone. All subjects will be followed clinically at 1, 6, and 12 months after percutaneous coronary intervention (PCI). The study evaluates co-primary endpoints including clinically relevant bleeding, ischemic adverse events such as death, myocardial infarction, target vessel revascularization, stent thrombosis, and a net clinical outcome combining these events. During the study, participants will undergo clinical follow-ups at specified intervals where researchers will assess bleeding events, ischemic complications, and overall clinical outcomes. The primary outcome measures track bleeding severity and ischemic events up to 12 months post-PCI. Safety monitoring includes evaluation of adverse events and adherence to the antiplatelet regimens. The total participation duration per subject is 12 months, with ongoing assessment to ensure safety and efficacy of the tailored antiplatelet therapy.

Age: 19Years +All GendersPhase 4
25 locations