Sir Run Run Shaw Hospital — Biomedical Watch V2

Traitements5programmes

Essais2liés

Publications0liées

SourceDBlocale

Traitements

5

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Colchicine (Colcrys®)This multicenter, randomized, open-label, noninferiority trial will compare two high-sensitivity C-reactive protein (hs-CRP) target-guided colchicine strategies in 1,768 adults with very-high-risk coronary artery disease after percutaneous coronary intervention, LDL cholesterol ≤1.4 mmol/L, and residual inflammation (hs-CRP 2.0-10.0 mg/L). Participants will be assigned 1:1 to a standard target of 1.0 to \<2.0 mg/L or an intensive target of \<1.0 mg/L. Both groups will start colchicine 0.25 mg orally once daily, with dose adjustments guided by hs-CRP and tolerability. The primary outcome is the 18-month composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, or ischemia-driven revascularization. The noninferiority hypothesis compares the standard target strategy with the intensive target strategy, with a prespecified hazard-ratio margin of 1.30.	Maladie coronarienne	Non applicable	Immunomodulation	China	À vérifier
RESTORE DEB paclitaxel-coated balloonThis prospective, multicenter, randomized, open-label, noninferiority trial will compare a sirolimus-coated balloon (SeQuent SCB) with a paclitaxel-coated balloon (RESTORE DEB) in 106 adults with recurrent coronary in-stent restenosis after prior paclitaxel-coated balloon treatment of the same segment. Participants will be randomized 1:1 to treatment of the target lesion with one of the study devices. The primary outcome is in-segment late lumen loss on quantitative coronary angiography 9 months after the index procedure. Clinical follow-up is scheduled at 30 days and 6, 9, and 12 months. Angiographic analysis and clinical event adjudication will be performed blinded to treatment assignment.	Maladie coronarienne	Non applicable	À vérifier	China	À vérifier
SeQuent SCB sirolimus-coated balloonThis prospective, multicenter, randomized, open-label, noninferiority trial will compare a sirolimus-coated balloon (SeQuent SCB) with a paclitaxel-coated balloon (RESTORE DEB) in 106 adults with recurrent coronary in-stent restenosis after prior paclitaxel-coated balloon treatment of the same segment. Participants will be randomized 1:1 to treatment of the target lesion with one of the study devices. The primary outcome is in-segment late lumen loss on quantitative coronary angiography 9 months after the index procedure. Clinical follow-up is scheduled at 30 days and 6, 9, and 12 months. Angiographic analysis and clinical event adjudication will be performed blinded to treatment assignment.	Maladie coronarienne	Non applicable	À vérifier	China	À vérifier
SeQuent SCB sirolimus-coated balloonThis prospective, multicenter, randomized, open-label, noninferiority trial will compare a sirolimus-coated balloon (SeQuent SCB) with a paclitaxel-coated balloon (RESTORE DEB) in 106 adults with recurrent coronary in-stent restenosis after prior paclitaxel-coated balloon treatment of the same segment. Participants will be randomized 1:1 to treatment of the target lesion with one of the study devices. The primary outcome is in-segment late lumen loss on quantitative coronary angiography 9 months after the index procedure. Clinical follow-up is scheduled at 30 days and 6, 9, and 12 months. Angiographic analysis and clinical event adjudication will be performed blinded to treatment assignment.	Maladie coronarienne	Non applicable	À vérifier	China	À vérifier
Colchicine (Colcrys®)This multicenter, randomized, open-label, noninferiority trial will compare two high-sensitivity C-reactive protein (hs-CRP) target-guided colchicine strategies in 1,768 adults with very-high-risk coronary artery disease after percutaneous coronary intervention, LDL cholesterol ≤1.4 mmol/L, and residual inflammation (hs-CRP 2.0-10.0 mg/L). Participants will be assigned 1:1 to a standard target of 1.0 to \<2.0 mg/L or an intensive target of \<1.0 mg/L. Both groups will start colchicine 0.25 mg orally once daily, with dose adjustments guided by hs-CRP and tolerability. The primary outcome is the 18-month composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, or ischemia-driven revascularization. The noninferiority hypothesis compares the standard target strategy with the intensive target strategy, with a prespecified hazard-ratio margin of 1.30.	Maladie coronarienne	Non applicable	Immunomodulation	China	À vérifier

Essais cliniques

2

Molécule	Indication / population	Phase	NCT	Titre	Statut
Colchicine (Colcrys®)	Maladie coronarienne	Non applicable	NCT07920133	Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)	NOT_YET_RECRUITING
SeQuent SCB sirolimus-coated balloon	Maladie coronarienne	Non applicable	NCT07920055	Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)	NOT_YET_RECRUITING

Publications

0

Molécule	Indication / population	Titre	Journal	Date
Aucune publication.