[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.