[Translation] Effect of amlodipine folic acid tablets versus amlodipine tablets on the risk of first ischemic stroke in H-type hypertensive patients with methylenetetrahydrofolate reductase (MTHFR) 677 CC/CT genotype: a multicenter, randomized, double-blind, double-dummy, controlled clinical trial

1、主要目的在MTHFR 677 CC/CT基因型伴高血浆总同型半胱氨酸水平（≥10 μmol/L）和低叶酸水平（<12ng/mL）的高血压参与者中，比较氨氯地平叶酸片（B组）与氨氯地平片（A组）预防首发缺血性脑卒中的疗效是否存在显著差异。 2、次要目的（1）在上述高血压参与者，分别在CC、CT 基因型人群，比较B组和A组间预防首发缺血性脑卒中的疗效是否存在显著差异。（2）在上述高血压参与者，分别在CC或CT 基因型人群、CC和CT 基因型人群比较B组和A组间预防首发脑卒中、心脑血管复合终点、肾脏终点的疗效是否存在显著差异。（3）在上述高血压参与者中，比较B组和A组间预防首发出血性脑卒中、首发心肌梗塞、首发冠状动脉血运重建术、心脑血管死亡的疗效是否存在显著差异。 3、其他目的（1）在上述高血压参与者中，比较B组和A组间预防恶性肿瘤和全因死亡的疗效是否存在显著差异。（2）在上述高血压参与者，分别在CC或CT 基因型人群、CC和CT 基因型人群比较B组和A组间预防血压水平，变异性及降压达标率、血清叶酸水平和变化、血浆总同型半胱氨酸水平和变化的疗效是否存在显著差异。

[Translation]

1. Main purpose Comparison of amlodipine folic acid tablets (B Is there any significant difference in the efficacy of preventing first ischemic stroke between Group A) and amlodipine tablets (Group A)? 2. Secondary purpose (1) Among the above-mentioned hypertensive participants, compare whether there is a significant difference in the efficacy of preventing first ischemic stroke between group B and group A in the CC and CT genotype groups. (2) Among the above-mentioned hypertensive participants, compare the efficacy of group B and group A in preventing first stroke, cardiovascular and cerebrovascular composite endpoints, and renal endpoints in the CC or CT genotype population, and the CC and CT genotype population respectively. The difference. (3) Among the above-mentioned hypertensive participants, compare whether there are significant differences in the efficacy of preventing first hemorrhagic stroke, first myocardial infarction, first coronary revascularization, and cardiovascular and cerebrovascular death between group B and group A. 3. Other purposes (1) Among the above-mentioned hypertensive participants, compare whether there is a significant difference in the efficacy of preventing malignant tumors and all-cause death between group B and group A. (2) Among the above-mentioned hypertensive participants, compare the preventive blood pressure levels, variability, blood pressure target compliance rate, serum folate levels and changes between group B and group A respectively in the CC or CT genotype population, CC and CT genotype population, Are there significant differences in therapeutic efficacy in plasma total homocysteine levels and changes.

Start Date22 Aug 2024

Sponsor / Collaborator

Shenzhen Osa Pharmaceutical Co., Ltd.

[+1]

CTR20222387 / RecruitingPhase 4

氨氯地平叶酸片与氨氯地平片比较对亚甲基四氢叶酸还原酶（MTHFR）677 TT基因型的高血压患者首发缺血性脑卒中风险的影响：一项多中心、随机、双盲、三模拟、对照临床试验

[Translation] Effect of amlodipine folic acid tablets versus amlodipine tablets on the risk of first ischemic stroke in hypertensive patients with methylenetetrahydrofolate reductase (MTHFR) 677 TT genotype: a multicenter, randomized, double-blind, triple-dummy, controlled clinical trial

1、主要研究目的在MTHFR 677 TT基因型的高血压参与者中，比较氨氯地平叶酸片（B+C组）与氨氯地平片（A组）预防首发缺血性脑卒中的疗效是否存在显著差异。 2、次要研究目的（1）在上述高血压参与者，比较B组vs.A组、C组vs.A组、B组vs.C组预防首发缺血性脑卒中的疗效是否存在显著差异。（2）在上述高血压参与者，比较B+C组vs.A组、B组vs.A组、C组vs.A组、B组vs.C组预防首发脑卒中、心脑血管复合终点、肾脏终点的疗效是否存在显著差异。（3）在上述高血压参与者，比较B+C组vs.A组预防首发出血性脑卒中首发心肌梗塞、首发冠状动脉血运重建术、心脑血管死亡的疗效是否存在显著差异。 3、其他研究目的（1）在上述高血压参与者，比较B+C组vs.A组预防恶性肿瘤和全因死亡的疗效是否存在显著差异。（2）在上述高血压参与者，比较B+C组vs.A组、B组vs.A组、C组vs.A组、B组vs.C组预防血压水平，变异性及降压达标率、血清叶酸水平和变化、血浆总同型半胱氨酸水平和变化的疗效是否存在显著差异。

[Translation]

1. Main research purpose Among hypertensive participants with MTHFR 677 TT genotype, compare whether there is a significant difference in the efficacy of amlodipine folic acid tablets (group B+C) and amlodipine tablets (group A) in preventing first ischemic stroke. 2. Secondary research purpose (1) Among the above-mentioned hypertensive participants, compare whether there is a significant difference in the efficacy of preventing first ischemic stroke between group B vs. group A, group C vs. group A, and group B vs. group C. (2) Among the above-mentioned hypertensive participants, compare group B+C vs. group A, group B vs. group A, group C vs. group A, group B vs. group C in preventing first stroke and cardiovascular and cerebrovascular composite endpoints. , whether there is a significant difference in the efficacy of renal endpoints. (3) In the above-mentioned hypertensive participants, compare group B+C vs. group A in preventing first hemorrhagic stroke. Is there a significant difference in the efficacy of first myocardial infarction, first coronary revascularization, and cardiovascular and cerebrovascular death? 3. Other research purposes (1) Among the above-mentioned hypertensive participants, compare whether there is a significant difference in the efficacy of preventing malignant tumors and all-cause death between group B+C and group A. (2) Among the above-mentioned hypertensive participants, compare the preventive blood pressure levels, variability and blood pressure reduction standards of group B+C vs. group A, group B vs. group A, group C vs. group A, group B vs. group C. rate, serum folate levels and changes, and plasma total homocysteine levels and changes.

Start Date22 Aug 2024

Sponsor / Collaborator

Shenzhen Osa Pharmaceutical Co., Ltd.

[+1]

NCT04974138 / Not yet recruitingPhase 4

Comparative Efficacy of Amlodipine Folic Acid vs. Amlodipine on the Risk of First Ischemic Stroke Among Participants With H-type Hypertension and MTHFR 677 CC/CT Genotype: A Multi-center, Randomized, Double-blind, Double-dummy, Controlled Clinical Trial

This is a multi-center, randomized, double-blind, double-dummy, controlled clinical trial. This trial will include 32,000 Chinese men and women with hypertension (H-type hypertension), MTHFR 677 CC or CT genotype, elevated plasma total homocysteine (tHcy ≥10µmol/L), and insufficient serum folate levels (<12ng/mL).
The participants will be first stratified by their MTHFR 677 genotype (CC vs. CT), then randomized to one of two treatment groups in a 1:1 ratio.
Group A: amlodipine tablet (5mg), taken orally, once daily, serving as active comparator.
Group B: amlodipine folic acid 5.8mg tablet (5mg amlodipine and 0.8mg folic acid), taken orally, once daily.
The treatment period is five years and primary endpoint is first ischemic stroke.

Start Date30 Jun 2024

Sponsor / Collaborator

Shenzhen Ausa Pharmed Co. Ltd.

[+6]

100 Clinical Results associated with Shenzhen Ausa Pharmed Co. Ltd.

0 Patents (Medical) associated with Shenzhen Ausa Pharmed Co. Ltd.

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21 Mar 2024·Journal of Translational Internal Medicine

Evaluation of plasma vitamin E and development of proteinuria in hypertensive patients

Article

Author: Wang, Binyan ; Liu, Lishun ; He, Panpan ; Zhang, Hao ; Qin, Xianhui ; Wang, Xiaobin ; Huo, Yong ; Liu, Chengzhang ; Nie, Jing ; Li, Huan ; Xu, Xiping ; Song, Yun ; Zhang, Yuanyuan ; Guo, Huiyuan

AbstractBackgroundThe prospective relationship between plasma vitamin E levels and proteinuria remains uncertain. We aimed to evaluate the association between baseline plasma vitamin E levels and the development of proteinuria and examine any possible effect modifiers in patients with hypertension.MethodsThis was a post hoc analysis of the renal sub-study of the China Stroke Primary Prevention Trial (CSPPT). In total, 780 participants with vitamin E measurements and without proteinuria at baseline were included in the current study. The study outcome was the development of proteinuria, defined as a urine dipstick reading of a trace or ≥ 1+ at the exit visit.ResultsDuring a median follow-up duration of 4.4 years, the development of proteinuria occurred in 93 (11.9%) participants. Overall, there was an inverse relationship between plasma vitamin E and the development of proteinuria (per standard deviation [SD] increment; odds ratio [OR]: 0.73, 95% confidence interval [CI]: 0.55–0.96). Consistently, when plasma vitamin E was assessed as quartiles, lower risk of proteinuria development was found in participants in quartiles 2–4 (≥ 7.3 μg/mL; OR: 0.57, 95% CI: 0.34–0.96) compared to those in quartile 1. None of the variables, including sex, age, and body mass index, significantly modified the association between vitamin E and proteinuria development.ConclusionThere was a significant inverse association between plasma vitamin E levels and the development of proteinuria in patients with hypertension. The results were consistent among participants with different baseline characteristics.

01 Feb 2024·Heliyon

Systemic immune-inflammation index predicts first stroke and affects the efficacy of folic acid in stroke prevention

Article

Author: Zheng, Jianhang ; Jia, Jia ; Qin, Xianhui ; Song, Yun ; Tang, Genfu ; Fan, Fangfang ; Liu, Lishun ; Zhang, Nan ; Chi, Xiying ; Huo, Yong ; Wang, Binyan ; Li, Jianping

BackgroundSystemic immune-inflammation index (SII) is a novel biomarker of growing interest in predicting stroke. The aim of this study was to investigate its predictive value and explore its effect modification on folic acid supplement for stroke primary prevention in a Chinese population with hypertension.MethodsA total of 10,013 participants from the China Stroke Primary Prevention Trial with available neutrophil, platelet and lymphocyte count were included, including 5,019 subjects in the enalapril group and 4,994 in the enalapril-folic acid group. SII was calculated as (platelet × neutrophil)/lymphocyte. The primary endpoint was first stroke. Cox proportional hazards models were used to evaluate the association between SII and first stroke.ResultsA U-shape association between SII and first stroke risk was observed in enalapril group. Compared with the reference group (Quartile 2: 335.1 to <443.9 × 10⁹ cell/L), the adjusted HRs were 1.68 (95 % CI: 1.06-2.66, P = 0.027) in Quartile 1 (<335.1 × 10⁹ cell/L), 1.43 (95 % CI: 0.90-2.27, P = 0.126) in Quartile 3 (443.9 to <602.6 × 10⁹ cell/L), and 1.61 (95 % CI: 1.03-2.51, P = 0.035) in Quartile 4 (≥602.6 × 10⁹ cell/L). There was no significant association between SII and first stroke in the enalapril-folic acid group, with adjusted HR of 0.92 (95%CI: 0.54-1.56, P = 0.749) in Quartile 1(<334.7 × 10⁹ cell/L), 1.36 (95%CI: 0.84-2.21, P = 0.208) in Quartile 3 (446.2 to <595.2 × 10⁹ cell/L), and 1.41 (95%CI: 0.87-2.27, P = 0.163) in Quartile 4 (≥595.2 × 10⁹ cell/L). A remarkable interaction between baseline SII and folic acid supplement for stroke prevention was observed, with particularly reduced risk by 44 % (HR: 0.56; 95 % CI: 0.34-0.90; P = 0.018) in the lowest SII group (P for interaction = 0.041).ConclusionsAmong Chinese adults with hypertension, both low and high SII at baseline predicted increased first stroke risk. And compensatory folic acid particularly reduced first stroke risk in the lowest SII subgroup.

01 Jan 2022·The American Journal of Clinical NutritionQ1 · MEDICINE

Plasma selenium and the risk of first stroke in adults with hypertension: a secondary analysis of the China Stroke Primary Prevention Trial

Q1 · MEDICINE

Article

Author: Wei, Yaping ; Zhou, Ziyi ; Li, Jianping ; Lin, Tengfei ; Zhang, Yan ; Qin, Xianhui ; Zhang, Hao ; Guo, Huiyuan ; Liu, Lishun ; Chen, Ping ; Liu, Chengzhang ; Ma, Hai ; Huang, Xiao ; Xu, Xiping ; Song, Yun ; Huo, Yong ; Li, Youbao ; Wang, Zhuo ; Wang, Binyan

BACKGROUNDPrevious studies have indicated that selenium (Se) may play an important role in cardio-cerebrovascular disease. However, the relation between circulating selenium and risk of first stroke remains inconclusive.OBJECTIVESWe conducted a secondary analysis of the China Stroke Primary Prevention Trial (CSPPT), using a nested case-control design, and aimed to investigate the correlation between Se concentration and first stroke risk in adults with hypertension and examine the potential effect modifiers.METHODSIn the CSPPT, a total of 20,702 adults with hypertension were randomly assigned to a double-blind daily treatment with either 10 mg enalapril and 0.8 mg folic acid or 10 mg enalapril alone. A total of 618 first stroke cases and 618 controls matched for age, sex, treatment group, and study site were included in this study.RESULTSDuring a median follow-up duration of 4.5 y (IQR: 4.2-4.6 y), there was a significant inverse association between plasma Se and the risk of first stroke (per SD increment; adjusted OR: 0.81; 95% CI: 0.68, 0.96) and ischemic stroke (per SD increment; adjusted OR: 0.76; 95% CI: 0.62, 0.93). Furthermore, a stronger inverse association between plasma Se and first stroke was observed in participants with higher folate concentrations at baseline [≥7.7 ng/mL (median), adjusted OR: 0.67; 95% CI: 0.54, 0.85, compared with <7.7 ng/mL, adjusted OR: 0.98; 95% CI: 0.80, 1.21; P-interaction = 0.008] and those with higher time-averaged systolic blood pressure (SBP) over the treatment period (≥140 mm Hg, adjusted OR: 0.71; 95% CI: 0.58, 0.86, compared with <140 mm Hg, adjusted OR: 0.96; 95% CI: 0.77, 1.20; P-interaction = 0.023).CONCLUSIONSThere was a significant inverse association between plasma Se and risk of first stroke in Chinese adults with hypertension, especially among those with higher baseline folate concentrations and those with higher time-averaged SBP over the treatment period. This trial was registered at clinicaltrials.gov as NCT00794885.

100 Deals associated with Shenzhen Ausa Pharmed Co. Ltd.

100 Translational Medicine associated with Shenzhen Ausa Pharmed Co. Ltd.

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