A Phase 1, Randomized, Double Blind, Placebo Controlled, Sequential, Ascending Single-Dose and Multiple-Dose First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AC430 in Healthy Subjects

AC430 will be administered, orally under fasting conditions (fasting 4 hours before and 2 hours after dosing) with approximately 240 mL of water either once daily or twice daily. It is designed to assess the safety, tolerability, and pharmacokinetics of single and multiple oral doses of AC430.

开始日期2010-11-01

申办/合作机构

Daiichi Sankyo, Inc.

100 项与 AC-430 相关的临床结果

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100 项与 AC-430 相关的转化医学

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100 项与 AC-430 相关的专利（医药）

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项与 AC-430 相关的文献（医药）

2024-09-01·Journal of the Formosan Medical Association

Impact of shared decision-making in Taiwanese patients with atrial fibrillation eligible for novel oral anticoagulant therapy

Article

作者: Chu, Chun-Yuan ; Chien, Szu-Chi ; Huang, Chi-Cheng ; Tu, Chung-Ming ; Lin, Tsung-Hsien ; Wu, Yen-Wen ; Chen, Ching-Pei ; Wu, Wei-Tsung ; Jhuo, Shih-Jie ; Yang, Yuan-Po ; Huang, Hung-Kain

BACKGROUND/PURPOSEShared decision-making (SDM) promotes patient awareness about medical conditions and treatments, facilitating patient involvement in care decisions. This two-stage multicenter study evaluated impacts of SDM in Taiwanese adults with atrial fibrillation (AF) eligible for novel oral anticoagulant (NOAC) therapy.METHODSParticipants were NOAC-naïve (part I) or dabigatran-experienced (part II). During Stage I, part I participants (n = 124) completed a semi-structured survey (understanding evaluation sections only) before and after viewing SDM materials on stroke prevention for AF. Surveys collected data on anxiety about AF, confidence in healthcare professionals, usefulness of the SDM materials, and perception of different NOACs. During Stage II, part I participants after being prescribed NOACs, and part II participants completed another survey to compare impacts of SDM.RESULTSDuring Stage I, dabigatran was the preferred NOAC after viewing the SDM materials among 90% of part I participants. During Stage II, both part I (n = 87) and part II participants (n = 104) completed another survey. Fewer part I participants were anxious about AF (p < 0.01), and more had confidence in healthcare professionals (p < 0.01) after viewing SDM materials than before. Most part I participants (≥90%) rated the SDM materials as "very helpful". In Stage II, participants viewing SDM before initiating dabigatran had lower anxiety (part I, 43%; part II, 53%; p < 0.01) and a higher trust (part I, 92%; part II, 84%; p < 0.01).CONCLUSIONIn conclusion, SDM reduced anxiety and improved trust in healthcare professionals among NOAC-naïve participants with AF.

2024-06-01·Journal of Arrhythmia

Impact of left ventricular diastolic function and direct oral anticoagulant use for predicting embolic events in patients with heart failure and atrial fibrillation

Article

作者: Yamamoto, Masaya ; Enomoto, Yoshinari ; Hara, Hisao ; Hayama, Hiromasa ; Hiroi, Yukio ; Yamamoto, Jumpei

AbstractBackgroundPatients with atrial fibrillation (AF) and heart failure (HF) have high stroke risk owing to left atrial dysfunction. However, anticoagulation is a concern in patients with high bleeding risk. We aimed to identify independent predictors of stroke in HF patients with AF.MethodsWe retrospectively examined 320 patients (mean age 79 ± 12 years, 163 women) hospitalized with acute HF complicated by AF between January 2014 and December 2018. Patients were followed from admission until ischemic stroke or systemic embolism (SSE) onset or death or were censored at the last contact date or September 2023.ResultsSSE occurred in 40 patients (median follow‐up of 528 days). Multivariate Cox regression analysis identified age (hazard ratio [HR] 1.04, 95% confidence interval [CI] 1.00–1.07, p = .034), direct oral anticoagulant (DOAC) use (HR 0.26, 95% CI 0.11–0.60, p = .002), and early diastolic peak flow velocity to early diastolic peak annular velocity (E/e'; HR 1.05, 95% CI 1.02–1.08, p < .001) to be independent predictors of SSE, whereas left atrial reservoir strain was not. After determining an appropriate E/e' cutoff by receiver‐operating characteristic curve analysis and adjusting the multivariate Cox model, E/e' ≥17.5 (HR 3.30, 95% CI 1.56–6.83, p = .001) independently predicted SSE. The results were consistent with no interaction in the subanalysis except for gender.ConclusionElderly patients not on DOACs with elevated E/e' may be at higher risk of stroke, suggesting that DOACs should be the first choice for patients with elevated E/e' and aggressive additional prophylaxis and careful follow‐up are needed.

2024-04-01·Health Science Reports

Safety and efficacy of direct oral anticoagulants in comparison to warfarin in obese patients with atrial fibrillation: A systematic review and meta‐analysis

Article

作者: Shantha, Ghanshyam ; Jha, Vivek ; Patel, Nimesh K ; Oli, Prakash Raj ; Zaman, Muhammad Omer ; Adelkhanova, Alla ; Biswas, Monodeep ; Shrestha, Dhan Bahadur ; Shtembari, Jurgen ; Bodziock, George Michael

AbstractBackground and AimObesity affects nearly 650 million adults worldwide, and the prevalence is steadily rising. This condition has significant adverse effects on cardiovascular health, increasing the risk of hypertension, coronary artery disease, heart failure, and atrial fibrillation (AF). While anticoagulation for obese patients with AF is a well‐established therapy for the prevention of thromboembolism, the safety and efficacy of different anticoagulants in this specific population are not well explored. This meta‐analysis aimed to compare direct oral anticoagulants (DOAC) to vitamin K antagonists in obese populations with AF.MethodsThe PRISMA guidelines were followed for this meta‐analysis, registered in PROSPERO (CRD42023392711). PubMed, PubMed Central, Embase, Cochrane Library, and Scopus databases were searched for relevant articles from inception through January 2023. Two independent authors screened titles and abstracts, followed by a full‐text review in Covidence. Data were extracted in Microsoft Excel and analyzed using RevMan v5.4 using odds ratio as an effect measure.ResultsTwo thousand two hundred fifty‐nine studies were identified from the database search, and 18 were included in the analysis. There were statistically significant reductions in the odds of ischemic and hemorrhagic stroke in the DOAC group compared with the VKA group (OR 0.70, CI 0.66–0.75) and (OR 0.47, CI 0.35–0.62), respectively. In addition, the DOAC group exhibited lower odds of systemic embolism (OR 0.67, CI 0.54–0.83), major bleeding (OR 0.62, CI 0.54–0.72), and composite outcome (OR 0.72, CI 0.63–0.81).ConclusionBased on the findings from this meta‐analysis, DOACs demonstrate superior safety and efficacy in obese patients with AF compared with VKAs. These results may have significant implications for guiding anticoagulation strategies in this patient population.

100 项与 AC-430 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB12535

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
类风湿关节炎	临床1期	美国	Daiichi Sankyo, Inc.	2010-11-01
炎症	临床1期	美国	Ambit Biosciences (Canada) Corp.	-
白血病	临床1期	-	Daiichi Sankyo Co., Ltd.	-
白血病	临床1期	美国	Ambit Biosciences (Canada) Corp.	-