Actively Recruiting
China Stroke Primary Prevention Trial 2 for Participants With H-type Hypertension and MTHFR 677 CC/CT Genotype (CSPPT2-CC/CT)
Led by Shenzhen Ausa Pharmed Co.,Ltd · Updated on 2025-02-26
32000
Participants Needed
20
Research Sites
305 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, 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.
CONDITIONS
Official Title
China Stroke Primary Prevention Trial 2 for Participants With H-type Hypertension and MTHFR 677 CC/CT Genotype (CSPPT2-CC/CT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 45 to less than 75 years
- Previously diagnosed with primary hypertension and treated within the past two weeks, or currently having blood pressure readings of systolic 60;140 mmHg or diastolic 60;90 mmHg at two separate visits
- MTHFR 677 CC or CT genotype confirmed by laboratory testing
- Plasma total homocysteine level equal to or above 10 bcmol/L
- Serum folate level below 12 ng/mL
- Voluntarily agreed to participate and provided signed informed consent
- Good compliance during the run-in period and likely to continue treatment
- No stroke or cardiovascular events during the run-in period
- Willingness to continue participation in the study
You will not qualify if you...
- Previously diagnosed with secondary hypertension
- History of stroke
- History of myocardial infarction
- History of heart failure
- History of atrial fibrillation
- Cardio-cerebral-kidney revascularization or large arterial stent
- Currently on dialysis or diagnosed with stage 4-5 chronic kidney disease or eGFR below 30 mL/min/1.73m
- Known congenital or acquired organic heart disease
- Severe liver disease including active viral hepatitis, abnormal liver function tests, subtotal gastrectomy or gastrojejunostomy
- Pulmonary heart disease
- Malignant tumors or other severe diseases
- Long-term gastrointestinal symptoms like anorexia, nausea, or abdominal bloating
- Vitamin B12 deficiency or related diseases
- Assessed unsuitable by investigator due to abnormal labs or clinical conditions
- History of intolerance to amlodipine, valsartan, indapamide, metoprolol, or folate-containing products
- Regular use of folic acid or vitamin B compounds in the past 3 months
- Dementia or severe mental disorders
- Unable to give informed consent
- Unlikely to complete study follow-up or planning to relocate
- History or expected poor compliance with antihypertensive medications
- Refusal to participate or inability to change current medication regimen
- Pregnancy, breastfeeding, or unwillingness/inability to use contraception if of childbearing potential
- Participation in other clinical trials of unapproved drugs within one month prior to study start or concurrent participation in trials affecting results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 20 locations
1
First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China, 233004
Not Yet Recruiting
2
Bozhou
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
4
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