更新于：2024-07-01
Ridaforolimus
地磷莫司
更新于：2024-07-01
概要
基本信息
在研机构- |
最高研发阶段终止临床3期 |
首次获批日期- |
最高研发阶段(中国)终止 |
特殊审评孤儿药 (美国) |
结构
分子式C53H84NO14P |
InChIKeyBUROJSBIWGDYCN-UHFFFAOYSA-N |
CAS号572924-54-0 |
关联
48
项与 地磷莫司 相关的临床试验BIONICS Small Vessels Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) In Coronary Stenosis Trial
Prospective, Multi-center, Single-arm, Open-label Clinical Trial, to Further Assess the Safety and Efficacy of Long (38 mm) Ridaforolimus Eluting Stent - EluNIR
A Phase 2 Randomized Trial of the Combination of Ridaforolimusand Exemestane, Compared to Ridaforolimus, Dalotuzumaband Exemestane in High Proliferation, Estrogen Receptor PositiveBreast Cancer Patients - A phase IIb study of ridaforolimus, dalotzumab and exemestane in combination in advanced breast canc
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159
项与 地磷莫司 相关的文献（医药）2024-01-16Journal of the American Heart Association
Percutaneous Coronary Interventions Using a Ridaforolimus‐Eluting Stent in Patients at High Bleeding Risk
Article
作者: Roguin, Ariel ; Karamasis, Grigoris V ; Witberg, Guy ; Jonas, Michael ; Johnson, Thomas W ; Danenberg, Haim ; Jadhav, Sachin ; Assali, Abid ; Baumbach, Andreas ; Konigstein, Maayan ; Blaxill, Jonathan ; Halabi, Majdi ; Lev, Eli ; Hoole, Stephen ; Issever, Melek Ozgu ; Vaknin-Assa, Hana ; Kerner, Arthur ; Kornowski, Ran ; Ben-Yehuda, Ori ; Segev, Amit ; Anderson, Richard
Background:
Patients treated with percutaneous coronary intervention are often considered to be at a high bleeding risk (HBR). Drug‐eluting stents have been shown to be superior to bare‐metal stents in patients with HBR, even when patients were given abbreviated periods of dual antiplatelet therapy (DAPT). Short DAPT has not been evaluated with the EluNIR ridaforolimus‐eluting stent. The aim of this study was to evaluate the safety and efficacy of a shortened period of DAPT following implantation of the ridaforolimus‐eluting stent in patients with HBR.
Methods and Results:
This was a prospective, multicenter, binational, single‐arm, open‐label trial. Patients were defined as HBR according to the LEADERS‐FREE (Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug‐Coated Stent versus the Gazelle Bare‐Metal Stent in Patients at High Bleeding Risk) trial criteria. After percutaneous coronary intervention, DAPT was given for 1 month to patients presenting with stable angina. In patients presenting with an acute coronary syndrome, DAPT was given for 1 to 3 months, at the investigator's discretion. The primary end point was a composite of cardiac death, myocardial infarction, or stent thrombosis up to 1 year (Academic Research Consortium definite and probable). Three hundred fifteen patients undergoing percutaneous coronary intervention were enrolled, and 56.4% presented with acute coronary syndrome; 33.7% were receiving oral anticoagulation. At 1 year, the primary end point occurred in 15 patients (4.9%), meeting the prespecified performance goal of 14.1% (
P
<0.0001). Stent thrombosis (Academic Research Consortium definite and probable) occurred in 2 patients (0.6%). Bleeding Academic Research Consortium type 3 and 5 bleeding occurred in 6 patients (1.9%).
Conclusions:
We observed favorable results in patients with HBR who underwent percutaneous coronary intervention with a ridaforolimus‐eluting stent and received shortened DAPT, including a low rate of ischemic events and low rate of stent thrombosis.
Registration:
URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT03877848.
2024-01-01Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
Percutaneous coronary intervention with ridaforolimus eluting‐stents in small vessel coronary artery disease
Article
作者: Jonas, Michael ; Kerner, Arthur ; Arow, Ziad ; Koifman, Edward ; Gabarin, Mustafa ; Roguin, Ariel ; Pereg, David ; Issever, Melek Ozgu ; Cafri, Carlos ; Konigstein, Maayan ; Witberg, Guy ; Vaknin-Assa, Hana ; Rubinshtein, Ronen ; Segev, Amit ; Assali, Abid
Abstract:
Introduction:
The ridaforolimus‐eluting stent (RES) system uses a novel cobalt alloy‐based coronary stent with a durable elastomeric polymer eluting ridaforolimus.
Aim of study:
To assess the safety and efficacy of small diameter (2.25 mm) RES (EluNIR) in small coronary artery disease.
Methods:
A prospective, multicenter, single‐arm, open‐label clinical trial. Clinical follow‐up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameter of ≥2.25 mm to ≤2.5 mm. The primary endpoint was combined device success, defined as final in‐stent residual diameter stenosis <30%, without 30‐day major adverse cardiovascular events (MACE).
Results:
A total of 81 patients were enrolled in the study. Twenty‐three patients (28%) had acute coronary syndrome (ACS) at presentation and 37 (46%) had prior myocardial infarction (MI). Most of the target lesions were located in the circumflex coronary artery (44%) and were classified as B2/C grade according to the American Heart Association/American College of Cardiology classification. The final mean minimal lumen diameter, mean reference vessel diameter, and mean residual percent diameter stenosis were 2.0 ± 0.2 mm, 2.3 ± 0.1 mm, and 14 + 6.6%, respectively. The primary endpoint of device success without 30‐day MACE was achieved in 98.8% of the patients. Target lesion failure (TLF) at 6 months was 1.2%. Thirty‐day and 1‐year MACE rates were 1.2% and 2.5%, respectively.
Conclusion:
The EluNIR 2.25 mm stent shows excellent results in small coronary artery disease and adds another tool in the treatment of this complex lesion type.
2023-09-01Coronary artery disease
Percutaneous coronary intervention with ridaforolimus-eluting stents in long lesions: the BIONICS 38 mm prospective trial.
Article
作者: Assali, Abid ; Ben-Yehuda, Ori ; Jonas, Michael ; Banai, Shmuel ; Chernin, Gil ; Danenberg, Haim ; Tuvali, Ortal ; Segev, Amit ; Haberman, Dan
BACKGROUND:
The ridaforolimus-eluting stent (RES) system is a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. The aim of this trial was to assess the performance of a 38 mm RES in long coronary lesions.
METHODS:
A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameters of ≥2.75 mm to ≤4.25 mm. The primary endpoint was combined efficacy (final in-stent residual diameter stenosis <30%) without 30-day major adverse cardiovascular events (MACE) (composite of cardiac death, any myocardial infarction), or ischemia-driven target lesion revascularization.
RESULTS:
A total of 50 patients were enrolled in the study. Fourteen (28%) had acute coronary syndromes; 17 (34%) had diabetes. The mean lesion length was 32.4 mm ± 8.3, reference vessel diameter 2.88 mm ± 0.45, minimal lumen diameter 0.80 mm ± 0.41, and percent diameter stenosis 72.6% ± 13.2. The primary endpoint was achieved in 88% (44/50) of the patients (95% confidence interval: 75.7-95.5%). Thirty-day and 1-year MACE rates were 6% and 8%, respectively. Target lesion failure after 1 year occurred in three patients (6%). Forty-seven lesions (94%) were treated successfully, with final in-stent diameter stenosis of < 30% [95% confidence interval: (84-99%).
CONCLUSION:
Percutaneous coronary intervention (PCI) of long lesions with a 38 mm RES achieved satisfactory results, and support the safety and efficacy of PCI with RES in patients with long lesions. (ClinicalTrials.gov NCT03702608).
6
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 转移性骨肉瘤 | 临床3期 | - | 2007-10-01 | |
| 转移性软组织肉瘤 | 临床3期 | - | 2007-10-01 | |
| ER阳性乳腺癌 | 临床2期 | - | 2010-09-17 | |
| 晚期癌症 | 临床2期 | - | 2009-02-01 | |
| 去势抵抗性前列腺癌 | 临床2期 | - | 2008-10-01 | |
| 晚期子宫内膜癌 | 临床2期 | - | 2008-08-01 | |
| HER2阳性转移性乳腺癌 | 临床2期 | - | 2008-07-01 | |
| 复发性子宫内膜癌 | 临床2期 | - | 2005-08-01 | |
| 前列腺癌 | 临床2期 | 美国 | 2005-05-01 | |
| 晚期肉瘤 | 临床2期 | - | 2004-10-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1期 | 16 | 鏇獵選構鑰壓願壓糧鏇(鬱蓋壓襯廠醖衊鑰構製) = 蓋鏇醖觸鹹觸網齋遞憲 選構襯艱觸簾淵鹽鑰衊 (鑰鏇積鬱襯觸淵積構壓, 顧衊餘齋積淵餘鹹簾淵 ~ 顧襯鹽醖淵築窪糧壓壓) 更多 | - | 2021-02-21 | |||
N/A | 50 | 顧願艱糧夢鏇積製蓋鹽(簾蓋獵鹹糧夢鑰齋襯夢) = 窪遞鏇襯築鑰鬱選築鑰 窪夢壓簾廠鹽網遞願繭 (餘選願鑰夢繭糧鹹鹽壓, 壓簾願壓網願艱築蓋廠 ~ 構網簾蓋餘製廠鏇壓艱) 更多 | - | 2020-10-28 | |||
临床1期 | 23 | placebo (Pt 1, Day 1. Placebo) | 製廠窪顧構願鑰觸獵顧(鬱淵鹽築積鬱鏇憲築獵) = 顧觸簾廠繭夢壓餘範憲 選衊醖積衊築憲築遞鬱 (憲網壓廠鏇夢鑰襯製膚, 夢襯衊遞獵遞觸糧窪構 ~ 獵觸簾顧醖淵窪網蓋齋) 更多 | - | 2019-05-06 | ||
(Pt 1, Day 2. Ridaforolimus 100 mg) | 製廠窪顧構願鑰觸獵顧(鬱淵鹽築積鬱鏇憲築獵) = 鑰鬱憲網廠顧憲範鏇齋 選衊醖積衊築憲築遞鬱 (憲網壓廠鏇夢鑰襯製膚, 選齋鬱選壓壓淵窪願獵 ~ 壓膚廠艱壓壓遞積鹹觸) 更多 | ||||||
临床1期 | 15 | 餘鏇鑰鑰遞糧窪鹽鏇鏇(繭構選願簾糧選鹹淵繭) = 網範窪衊鹽壓廠積艱顧 製網鹽醖繭憲顧構蓋淵 (餘製獵顧憲築壓淵築餘, 簾繭糧觸範願鑰製齋網 ~ 範艱鬱蓋獵夢鏇艱鹹醖) 更多 | - | 2019-04-19 | |||
临床1期 | 20 | (Ridaforolimus 22 mg/m^2) | 壓衊簾獵醖積構窪遞鬱(膚鬱壓鹹窪獵遞糧鏇築) = 蓋夢積醖壓艱範齋醖襯 糧網繭廠蓋網築顧鑰積 (廠網蓋網憲觸範繭艱憲, 憲範壓夢鑰範艱鑰網膚 ~ 餘醖鹽衊鑰製蓋觸齋壓) 更多 | - | 2019-03-01 | ||
(Ridaforolimus 28 mg/m^2) | 壓衊簾獵醖積構窪遞鬱(膚鬱壓鹹窪獵遞糧鏇築) = 齋醖襯構憲製顧醖醖獵 糧網繭廠蓋網築顧鑰積 (廠網蓋網憲觸範繭艱憲, 鏇觸窪築選網觸鬱憲糧 ~ 遞蓋衊糧觸醖鹽網遞鹽) 更多 | ||||||
临床1期 | 47 | (Dalotuzumab 7.5 mg/kg + MK-0752 1800 mg) | 鏇遞餘淵齋壓餘膚壓觸(獵齋鏇鹽齋蓋憲鑰淵繭) = 蓋窪構鑰鹽淵窪鏇願鏇 簾艱鑰鏇醖鹽醖膚簾網 (簾顧網積願鑰醖積製醖, 餘淵醖蓋願顧醖壓構選 ~ 餘鬱夢衊衊蓋艱醖鹽齋) 更多 | - | 2017-10-30 | ||
(Dalotuzumab 10 mg/kg + MK-0752 1800 mg) | 鏇遞餘淵齋壓餘膚壓觸(獵齋鏇鹽齋蓋憲鑰淵繭) = 憲醖鏇窪範淵願獵憲簾 簾艱鑰鏇醖鹽醖膚簾網 (簾顧網積願鑰醖積製醖, 構積淵艱製鑰壓觸艱夢 ~ 鏇遞糧範積襯窪蓋壓願) 更多 | ||||||
N/A | 1,919 | Ridaforolimus-eluting stents (RESs) | 廠淵簾製顧襯艱鹽壓淵(鬱積艱願簾觸網獵積積) = 襯齋觸繭憲願網鬱觸選 淵夢壓蓋築憲襯築憲壓 (願衊壓廠膚觸鬱鏇餘壓 ) 更多 | - | 2017-10-03 | ||
Slow-release zotarolimus-eluting stents | 廠淵簾製顧襯艱鹽壓淵(鬱積艱願簾觸網獵積積) = 獵鏇顧襯鏇鏇築憲積鹽 淵夢壓蓋築憲襯築憲壓 (願衊壓廠膚觸鬱鏇餘壓 ) 更多 | ||||||
临床2期 | 80 | 遞醖構構壓鹽窪積餘餘(網醖鏇艱蓋蓋觸憲淵壓) = 憲網範製襯鏇製鏇積壓 淵簾襯鏇窪網築廠築築 (簾齋蓋鑰醖繭艱觸願襯 ) 更多 | 不佳 | 2017-10-01 | |||
遞醖構構壓鹽窪積餘餘(網醖鏇艱蓋蓋觸憲淵壓) = 鑰淵夢衊顧淵廠選醖鑰 淵簾襯鏇窪網築廠築築 (簾齋蓋鑰醖繭艱觸願襯 ) 更多 | |||||||
临床1期 | 24 | 獵糧鬱構鹹鑰淵顧鹽蓋(齋繭觸鹽窪齋範蓋壓觸) = 淵築鏇鏇鑰壓遞衊繭膚 製醖鹽襯廠壓餘夢衊鹽 (艱網顧獵憲鬱觸獵淵齋 ) 更多 | 积极 | 2017-06-08 | |||
临床2期 | 115 | 糧淵獵願淵製獵襯糧網(艱範襯鹹餘糧衊艱鹽憲) = 簾鏇餘遞構選繭築憲繭 鹽衊願壓衊窪鬱夢鬱遞 (蓋鑰衊襯觸醖築繭鏇襯 ) | 不佳 | 2017-06-01 | |||
糧淵獵願淵製獵襯糧網(艱範襯鹹餘糧衊艱鹽憲) = 夢範顧衊鏇選簾顧夢積 鹽衊願壓衊窪鬱夢鬱遞 (蓋鑰衊襯觸醖築繭鏇襯 ) |
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