Actively Recruiting
China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype
Led by Shenzhen Ausa Pharmed Co.,Ltd · Updated on 2025-02-26
24000
Participants Needed
20
Research Sites
253 weeks
Total Duration
On this page
Sponsors
S
Shenzhen Ausa Pharmed Co.,Ltd
Lead Sponsor
P
Peking University First Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 45 to less than 75 years
- Diagnosed with primary hypertension and treated with antihypertensive medication in the past two weeks, or untreated but with blood pressure readings of SBP 6140 mmHg and/or DBP 690 mmHg at two separate visits
- Confirmed MTHFR 677 TT genotype by central lab test or official previous report
- Voluntarily consented to participate
- Good compliance and tolerance to amlodipine during run-in period
- No stroke or cardiovascular events during run-in period
- Willingness to continue study participation
You will not qualify if you...
- Diagnosed with secondary hypertension
- History of stroke, myocardial infarction, heart failure, or atrial fibrillation
- Previous cardio-cerebral-kidney revascularization or large arterial stent
- Currently on dialysis or diagnosed with stage 4-5 chronic kidney disease (eGFR <30 mL/min/1.73m8)
- Congenital or acquired organic heart disease, including aortic stenosis
- Active viral hepatitis or severe liver dysfunction
- History of subtotal gastrectomy or gastrojejunostomy
- Pulmonary heart disease
- Malignant tumors or other severe diseases
- Long-term gastrointestinal symptoms such as anorexia, nausea, or bloating
- Vitamin B12 deficiency or related diseases
- Unsuitable for study based on abnormal labs or clinical conditions
- Significant intolerance to amlodipine, valsartan, indapamide, metoprolol, or folate-containing products
- Regular folic acid or vitamin B compound use in the past 3 months
- Dementia, severe mental disorders, inability to consent
- Unlikely to complete follow-up or plans to move away
- Poor compliance history with antihypertensive medications
- Refusal to participate or inability to change current drug regimen
- Pregnant or breastfeeding women, or unwilling/unable to use contraception
- Participation in another clinical trial of unapproved or investigational drugs within one month prior to first visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
First Affillated Hospital of Bengbu Medical University
Bengbu, Anhui, China, 233004
Not Yet Recruiting
2
Bozhou People's Hospital
Bozhou, Anhui, China
Not Yet Recruiting
3
Chizhou People's Hospital
Chizhou, Anhui, China
Not Yet Recruiting
4
Taihe County People's Hospital
Fuyang, Anhui, China
Not Yet Recruiting
5
Peking University First Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
6
Yangjiang People's Hospital
Yangjiang, Guangdong, China
Not Yet Recruiting
7
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Not Yet Recruiting
8
The First Affiliated Hospital of Hunan University of Medicine
Huaihua, Hunan, China
Not Yet Recruiting
9
Loudi Central Hospital
Loudi, Hunan, China
Not Yet Recruiting
10
Lianyungang Oriental Hospital
Lianyungang, Jiangsu, China, 222042
Actively Recruiting
11
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Not Yet Recruiting
12
The Second People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Not Yet Recruiting
13
Yancheng First People's Hospital
Yancheng, Jiangsu, China
Not Yet Recruiting
14
The First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Not Yet Recruiting
15
Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
16
Weinan Central Hospital
Weinan, Shaanxi, China
Not Yet Recruiting
17
Tengzhou Central People's Hospital
Zaozhuang, Shandong, China, 277599
Not Yet Recruiting
18
Chengdu Fifth People's Hospital
Chengdu, Sichuan, China
Not Yet Recruiting
19
Deyang People's Hospital
Deyang, Sichuan, China
Not Yet Recruiting
20
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Not Yet Recruiting
Research Team
M
Minqing Tian, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here