This is a multi-center, randomized, double-blind, triple-dummy, controlled trial in 24,000 Chinese men and women with hypertension and MTHFR 677 TT genotype. The study participants will be randomized to one of the three treatment groups: 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. Group C: amlodipine folic acid 5.8mg tablet plus 5-methyltetrahydrofolate (5-MTHF, 0.4mg), taken orally, once daily. The primary endpoint is first ischemic stroke.
This study consists of 3 periods: Screening, Run-in, and Randomized treatment. Period I: Screening (V0) The purpose of Period I is to obtain informed consent and screen for eligible participants. After obtaining written informed consent, at the screening visit (V0), participants will complete a face-to-face interview and clinical evaluation and measurements. Their biological samples will be collected for laboratory analyses. Collectively, these information will help to determine eligibility for inclusion in the study. Period II: Run-in Period (VD) The purpose of Run-in is to assess participants' compliance for following the amlodipine treatment regimen as well as to observe participants' tolerance to amlodipine, so as to screen out those with poor compliance or intolerance to amlodipine treatment. The run-in phase lasted 2 to 4 weeks, during which oral administration of Amlodipine tablets (5 mg) was given once daily. Period III: Randomized Treatment (V1-V21) This is a 5-year period of randomized, double-blind, triple-dummy, controlled treatment. At each of the research centers, participants who remain eligible for participation in the study will be randomized into 3 treatment groups: A. Amlodipine-only (5mg/d) with an amlodipine folic acid placebo and 5-MTHF placebos. B. Amlodipine folic acid tablet (5.8mg/d) with amlodipine placebo and 5-MTHF placebo. C. Amlodipine folic acid tablets (5.8mg/d) and 5-MTHF (0.4mg/d) with an amlodipine placebo in a 1:1:1 ratio, using the randomization and trial supply management (RTSM) platform. During the treatment period, other antihypertensive drugs can be added to achieve blood pressure control (BP ≤140/90mmHg), including Valsartan (80mg/d), or/and Indapamide (1.5mg/d), or/and metoprolol tartrate tablets (25mg/d). Participants will be followed up every 3 months during the treatment period, and the treatment drugs will be distributed at each visit. A total of 24,000 participants will be randomly assigned to one of three treatment groups (Group A n=8,000, Group B n=8,000, Group C n=8,000). Based on published data from CSPPT (Huo et al, JAMA, 2015), the 5-year cumulative incidence of first ischemic stroke in the amlodipine-only group is 3.5%. Assuming the 5-year cumulative incidence of first ischemic stroke in the amlodipine-only group is around 3.5%, this trial has 80% power to detect a 20% difference between group A and group B+C in the observed hazard ratio (HR) for incident ischemic stroke (HR≤0.80), at a two-sided significance level of α=0.05. If instead, the 5-year incidence of ischemic stroke in the amlodipine-only group is 2.5%, this trial has 80% power to detect a 23% difference between the treatment groups (A vs B+C) (HR≤0.77). There are two planned interim analyses, one at the end of the third year, and another at the end of the fourth year. The O'Brien-Fleming alpha-spending function will be used to define the significance level of each interim analysis to ensure that the final overall two-sided significance level of α=0.05 is met.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24,000
The amlodipine used in this study is a listed product.
The amlodipine besylate and folic acid tablets have been approved for listing by the China Food and Drug Administration, approval number: Zhunzi H20180020.
The 5-MTHF used in this study is a listed product.
Amlodipine placebos are dummy pills of amlodipine with identical appearance.
Amlodipine folic acid placebos are dummy pills of amlodipine folic acid with identical appearance.
5-MTHF placebos are the dummy pills of 5-MTHF with identical appearance.
First Affillated Hospital of Bengbu Medical University
Bengbu, Anhui, China
NOT_YET_RECRUITINGBozhou People's Hospital
Bozhou, Anhui, China
NOT_YET_RECRUITINGChizhou People's Hospital
Chizhou, Anhui, China
NOT_YET_RECRUITINGTaihe County People's Hospital
Fuyang, Anhui, China
NOT_YET_RECRUITINGPeking University First Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGYangjiang People's Hospital
Yangjiang, Guangdong, China
NOT_YET_RECRUITINGThe Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Hunan University of Medicine
Huaihua, Hunan, China
NOT_YET_RECRUITINGLoudi Central Hospital
Loudi, Hunan, China
NOT_YET_RECRUITINGLianyungang Oriental Hospital
Lianyungang, Jiangsu, China
RECRUITING...and 10 more locations
First ischemic stroke
The primary aim of the trial is to determine whether amlodipine folic acid tablets (including Group B and Group C), compared to amlodipine alone (Group A), can further reduce the risk of first ischemic stroke among eligible participants with hypertension and the MTHFR 677 TT genotype.
Time frame: By the end of the fifth year of the study
First ischemic stroke (for refined treatment group comparisons)
We will examine whether there exist significant differences in efficacy in reducing the risk of first ischemic stroke between the following pairs of treatment groups: Group B vs. Group A Group C vs. Group A Group B vs. Group C
Time frame: By the end of the fifth year of the study
First stroke (ischemic and hemorrhagic)
We will examine whether there exist significant differences in efficacy in reducing the risk of first stroke between the following pairs of treatment groups: Groups B + C vs. Group A Group B vs. Group A Group C vs. Group A Group B vs. Group C
Time frame: By the end of the fifth year from baseline
Composite cardiovascular endpoint (first non-fatal stroke, first non-fatal myocardial infarction, cardiovascular death)
We will examine whether there exist significant differences in efficacy in reducing the risk of composite cardiovascular endpoint between the following pairs of treatment groups: Groups B + C vs. Group A Group B vs. Group A Group C vs. Group A Group B vs. Group C
Time frame: By the end of the fifth year from baseline
Kidney outcomes
1. The primary kidney outcome is composite kidney outcome, defined as: (1) a decrease in eGFR of 30% or more and to a level of less than 60 mL/min/1.73 m2 if the baseline eGFR is 60 mL/min/1.73 m2 or more, or (2) a decrease in eGFR of 50% or more if the baseline eGFR is less than 60 mL/min/1.73 m2, or (3) end-stage kidney disease (ESKD) (eGFR \<15 mL/min/1.73m2 or dialysis or kidney transplantation). 2. Secondary kidney outcomes: (1) eGFR decline ≥40% from baseline, or end-stage kidney disease; (2) annual rate of relative decline in eGFR; (3) Incidence of proteinuria, or progression of proteinuria. We will examine whether there exist significant differences in treatment efficacy on the above kidney endpoints between the following pairs of treatment groups: Groups B + C vs. Group A Group B vs. Group A Group C vs. Group A Group B vs. Group C
Time frame: By the end of the fifth year from baseline
First hemorrhagic stroke
We will examine whether amlodipine folic acid tablets (including Groups B and C), compared to amlodipine alone (Group A), show significantly greater efficacy in preventing first hemorrhagic stroke.
Time frame: By the end of the fifth year from baseline
First myocardial infarction
We will examine whether amlodipine folic acid tablets (including Groups B and C), compared to amlodipine alone (Group A), show significantly greater efficacy in preventing first myocardial infarction.
Time frame: By the end of the fifth year from baseline
First coronary revascularization (coronary artery bypass grafting [CABG] or percutaneous coronary intervention [PCI])
We will examine whether amlodipine folic acid tablets (including Groups B and C), compared to amlodipine alone (Group A), show significantly greater efficacy in preventing first coronary revascularization.
Time frame: By the end of the fifth year from baseline
Cardiovascular death
We will examine whether amlodipine folic acid tablets (including Groups B and C), compared to amlodipine alone (Group A), show significantly greater efficacy in preventing cardiovascular death.
Time frame: By the end of the fifth year from baseline
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