Primary HypertensionPhase 4CSPPTNCT00794885
China Stroke Primary Prevention Trial
A Phase 4 study testing Enalapril/folic acid and Enalapril maleate in people with Primary Hypertension, run by Shenzhen Ausa Pharmed Co.,Ltd at 2 sites in China.
Trial summary
The purpose of this trial is to confirm that enalapril maleate and folic acid tablets is more effective in preventing stroke among the patients with primary hypertension when compared to enalapril maleate. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Primary Hypertension
- What is being tested?
- Enalapril/folic acid and Enalapril maleate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,702 participants
- Where
- 2 sitesChina
- Study dates
- May 2008to Jun 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BP≥140/90 mmHg in both of the two screening visits or currently under anti-hypertension treatment
- 45 - 75 years old
- Successful determination of MTHFR C677T genotype
- For pre-menopausal women, agreed to use contraceptives during the trial
- Signed the written informed consent
Who cannot join
- Having a history of stroke
- Having a history of myocardial infarction
- Having a history of physician diagnosed heart failure
- Post- coronary revascularization
- Severe somatic disease such as cancer
- Secondary hypertension
Show all 14Show fewer
- Congenital or acquired organic heart diseases
- Contraindicated to angiotensin-converting enzyme inhibitor(ACEI)
- History of ACEI adverse effects
- Currently long-term use of folic acid or vitamin B12 or vitamin B6
- Pregnant or child breastfeeding women
- Severe mental disorders
- Lab tests indicating abnormal liver or kidney function
- Unwilling to participate the trial, unwilling to change the current antihypertensive treatment
Trial locations and contacts
2 sites in 1 country.
China2 sites
Anqing Branch, Anhui Institute of Biomedical Research
Anqing, Anhui, 246000
Lianyungang Center for Advanced Research in Cardiovascular Diseases
Lianyungang, Jiangsu, 222003
About this study
Official title: Enalapril Maleate and Folic Acid Tablets for Primary Prevention of Stroke in Patients With Hypertension: a Post-marketing, Double-blind, Randomized Controlled Trial.
The purpose of this trial is to confirm that enalapril maleate and folic acid tablets is more effective in preventing stroke among the patients with primary hypertension when compared to enalapril maleate.
Read the detailed description
Primary hypertension is the most important risk factor leading to cardiovascular events. Successful management of hypertension is a key to prevent these events. Hyperhomocysteinemia (HHcy) is another independent risk factor, especially for stroke. Our team's prospective nested case-control study of 39165 subjects in China showed that incidence of cardiovascular events (especially stroke) was strongly associated with plasma level of total homocysteine (tHcy). The coexistence of hypertension and HHcy dramatically increased the risk of stroke by 25 to 30 times as compared to the subjects without the two risk factors (Graham et al, 1997). Findings from previous and our studies clearly indicate that simultaneous control of hypertension and HHcy is pivotal in reducing cardiovascular events morbidity and mortality in China.
It has been well documented that folic acid is effective in lowering the level of plasma tHcy. While controversial remains on its efficacy on preventing cardiovascular events, a study done by our team: "Efficacy of folic acid supplementation in stroke prevention: a meta-analysis" (Wang et al, 2007) provide coherent evidence that folic acid supplementation can decrease the risk of stroke by 18%, and 25% in populations where folic fortification was not issued, or used for primary prevention.
C677T gene polymorphism of 5,10-methylenetetrahydrofolate reductase (MTHFR) is one of the genetic determinators of plasma tHcy level. Observational studies showed that individuals with TT genotype tend to have high plasma tHcy and elevated risk of cardiovascular events (Cronin et al. 2005), and folic acid supplementation led to a remarkable reduction in plasma tHcy. In short, previous studies by others and by our team have provided strong rationale for our proposed trial as detailed below.
The hypothesis of the current study is that a combination of antihypertensive drug (e.g., enalapril) with folic acid is not only efficacious, but also is safe and highly cost-effective than antihypertensive (e.g., enalapril) used alone to prevent stroke in hypertensive patients.
This trial will enroll 20,000 patients with primary hypertension and with known MTHFR C677T genotype. Subjects will be first stratified by genotypes, and then randomly assigned to treatment groups. The study patients will be instructed to take orally enalapril 10 mg daily or enalapril/folic acid 10mg/0.8mg tablets daily for a maximum of 5 years. The follow-up is given every 3 months.
The incidence and time of first-time stroke episode (primary endpoint) or composite cardiovascular events are used as endpoints. They will be compared by treatment groups with and without stratification by C677T gene polymorphisms. The potential interaction between treatment groups and C677T gene polymorphisms on therapeutic efficacy will also be tested.
This will be the first and largest trial of this kind in Chinese population. The findings from this trial may have the potential to transform current clinical and public health findings into practice.
- Conditions
- Primary Hypertension
- Being tested
- Enalapril/folic acid, Enalapril maleate
- Keywords
- hypertension, stroke, cardiovascular events, enalapril, folic acid, randomized controlled trial, MTHFR C677T genotype
- Medical subject headings
- Essential Hypertension, Hypertension, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enalapril/folic acidDrug
Also called Enalapril Maleate and Folic Acid Tablet
Enalapril/folic acid, (10mg enalapril/0.8mg folic acid)/tablet, taken orally and once daily for a maximum of 5 years. Combination with other anti-hypertension drugs are allowed.
Enalapril maleateDrug
Also called Lameiya,Yabao Pharmaceutical
Enalapril, 10mg/tablet, taken orally once daily for a maximum of 5 consecutive years. Combination with other anti-hypertension drugs are allowed.
| Study group | Role | What they receive |
|---|---|---|
| Enalapril/folic acid | Experimental | A fixed combination drug is given. The dose is fixed in enalapril 10 mg / folic acid 0.8 mg per day. Receives: Drug: Enalapril/folic acid |
| Enalapril | Active comparator | Enalapril maleate 10 mg per day is given Receives: Drug: Enalapril maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
First attack of symptomatic stroke ( ischemic or hemorrhagic)
Patients are followed-up every 3 months. All endpoint outcomes are assessed by the Endpoint Adjudication Committee of the study.
Measured: during the trial period
Secondary outcomes (5)
Composite major cardiovascular events
Measured: during the trial period
All-cause death
Measured: during the trial period
First attack of ischemic stroke and resultant death
Measured: during the trial period
First attack of hemorrhagic stroke and resultant death
Measured: during the trial period
Myocardial infarction and resultant death
Measured: during the trial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study startMay 2008
- Primary completionAug 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Primary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20,702 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Ausa Pharmed Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Anhui Medical University
- Responsible party
- Sponsor
- Investigators
- Yong Huo, M.D., Principal investigator, The First Hospital, Beijing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794885
- Sponsor's protocol ID
- Ausa-CSPPT
- Acronym
- CSPPT
- Status last verified
- Aug 2014
- First submitted
- 19 Nov 2008
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang X, Qin X, Demirtas H, Li J, Mao G, Huo Y, Sun N, Liu L, Xu X. Efficacy of folic acid supplementation in stroke prevention: a meta-analysis. Lancet. 2007 Jun 2;369(9576):1876-1882. doi: 10.1016/S0140-6736(07)60854-X.
PubMed 17544768Graham IM, Daly LE, Refsum HM, Robinson K, Brattstrom LE, Ueland PM, Palma-Reis RJ, Boers GH, Sheahan RG, Israelsson B, Uiterwaal CS, Meleady R, McMaster D, Verhoef P, Witteman J, Rubba P, Bellet H, Wautrecht JC, de Valk HW, Sales Luis AC, Parrot-Rouland FM, Tan KS, Higgins I, Garcon D, Andria G, et al. Plasma homocysteine as a risk factor for vascular disease. The European Concerted Action Project. JAMA. 1997 Jun 11;277(22):1775-81. doi: 10.1001/jama.1997.03540460039030.
PubMed 9178790Cronin S, Furie KL, Kelly PJ. Dose-related association of MTHFR 677T allele with risk of ischemic stroke: evidence from a cumulative meta-analysis. Stroke. 2005 Jul;36(7):1581-7. doi: 10.1161/01.STR.0000169946.31639.af. Epub 2005 Jun 9.
PubMed 15947278Wang L, Liu Z, Zhang N, Zhang L, Liu X, Fan F, Zhang Y, Li J. Association Between Neutrophil Percentage-to-Albumin Ratio (NPAR) and Risk of Stroke in Patients With Hypertension: A Cohort Study. J Clin Hypertens (Greenwich). 2026 Jan;28(1):e70200. doi: 10.1111/jch.70200.
PubMed 41543379Zhang N, Mei J, Fan F, Zhang Y, Zhou Z, Li J. Posttreatment Blood Pressure as a Key Predictor in a 5-Year Stroke Prediction Model. J Clin Hypertens (Greenwich). 2025 Jan;27(1):e14974. doi: 10.1111/jch.14974.
PubMed 39821957Meng Y, Liu L, Chen X, Zhao L, She H, Zhang W, Zhang J, Qin X, Li J, Xu X, Wang B, Hou F, Tang G, Liao R, Huo Y, Li J, Yang L. Associations between brachial-ankle pulse wave velocity and hypertensive retinopathy in treated hypertensive adults: Results from the China Stroke Primary Prevention Trial (CSPPT). J Clin Hypertens (Greenwich). 2024 Jun;26(6):724-734. doi: 10.1111/jch.14820. Epub 2024 Apr 29.
PubMed 38683601Li W, Li C, Liu T, Song Y, Chen P, Liu L, Wang B, Qu J. The association of serum choline concentrations with the risk of cancers: a community-based nested case-control study. Sci Rep. 2023 Dec 13;13(1):22144. doi: 10.1038/s41598-023-49610-3.
PubMed 38092871Lei W, Liu Z, Su Z, Meng P, Zhou C, Chen X, Hu Z, Xiao A, Zhou M, Huang L, Zhang Y, Qin X, Wang J, Zhu F, Nie J. Hyperhomocysteinemia potentiates megakaryocyte differentiation and thrombopoiesis via GH-PI3K-Akt axis. J Hematol Oncol. 2023 Jul 27;16(1):84. doi: 10.1186/s13045-023-01481-x.
PubMed 37501059Li Y, Song Y, Liu L, Wang X, Zhou Z, Zhang N, Wang Z, Chen P, Shi H, Huo Y, Xu X, Li J. Inverse Association Between Baseline Plasma Selenium Concentrations and Risks of Renal Function Decline in Hypertensive Adults. J Nutr. 2023 Jan 14;152(12):2754-2760. doi: 10.1093/jn/nxac211.
PubMed 36083982He Q, Zhang N, Liang Q, Wang Z, Chen P, Song Y, Zhou Z, Wei Y, Duan Y, Wang B, Qin P, Qin X, Xu X. Serum Serine and the Risk of All-Cause Mortality: A Nested Case-Control Study From the China Stroke Primary Prevention Trial (CSPPT). Front Nutr. 2022 Jul 12;9:946277. doi: 10.3389/fnut.2022.946277. eCollection 2022.
PubMed 35903445Wei Y, Wang Z, He Q, Siddiqi SM, Zhou Z, Liu L, Song Y, Chen P, Li J, Zhang Y, Mao G, Wang B, Tang G, Qin X, Xu X, Huo Y, Guo H, Zhang H. Inverse Association between Plasma Phylloquinone and Risk of Ischemic Stroke in Chinese Adults with Hypertension and High BMI: A Nested Case-Control Study. J Nutr. 2022 Aug 9;152(8):1927-1935. doi: 10.1093/jn/nxac131.
PubMed 35660920Song M, Xu BP, Liang Q, Wei Y, Song Y, Chen P, Zhou Z, Zhang N, He Q, Liu L, Liu T, Zhang K, Hu C, Wang B, Xu X, Shi H. Association of serum choline levels and all-cause mortality risk in adults with hypertension: a nested case-control study. Nutr Metab (Lond). 2021 Dec 20;18(1):108. doi: 10.1186/s12986-021-00637-1.
PubMed 34930356Song Y, Li J, Liu L, Xu R, Zhou Z, Xu B, Lin T, Chen P, Li H, Li Y, Liu C, Huang X, Wang B, Zhang Y, Li J, Huo Y, Ren F, Xu X, Zhang H, Qin X. Plasma Vitamin E and the Risk of First Stroke in Hypertensive Patients: A Nested Case-Control Study. Front Nutr. 2021 Nov 3;8:734580. doi: 10.3389/fnut.2021.734580. eCollection 2021.
PubMed 34805240Wei Y, Xu B, Wang Z, Zhou Z, Liu L, Lin T, Song Y, Li J, Zhang Y, Huo Y, Mao G, Wang B, Tang G, Qin X, Zhang H, Wang X, Guo H, Xu X. Joint Associations between Plasma 25-Hydroxyvitamin D, Glycemic Status, and First Stroke in General Hypertensive Adults: Results from the China Stroke Primary Prevention Trial (CSPPT). J Nutr. 2022 Jan 11;152(1):246-254. doi: 10.1093/jn/nxab339.
PubMed 34558624Wang Z, Ma H, Song Y, Lin T, Liu L, Zhou Z, Wei Y, Huang X, Chen P, Liu C, Li Y, Wang B, Li J, Zhang Y, Huo Y, Zhang H, Xu X, Qin X, Guo H. Plasma selenium and the risk of first stroke in adults with hypertension: a secondary analysis of the China Stroke Primary Prevention Trial. Am J Clin Nutr. 2022 Jan 11;115(1):222-231. doi: 10.1093/ajcn/nqab320.
PubMed 34549258
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enalapril Maleate and Folic Acid Tablets for Primary Prevention of Stroke in Patients With Hypertension: a Post-marketing, Double-blind, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00794885
- Acronym / sponsor ID
- CSPPT / Ausa-CSPPT
- Conditions
- Primary Hypertension
- Keywords
- hypertension, stroke, cardiovascular events, enalapril, folic acid, randomized controlled trial, MTHFR C677T genotype
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,702 participants (actual)
- Lead sponsor
- Shenzhen Ausa Pharmed Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Anhui Medical University
- Study start
- May 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to confirm that enalapril maleate and folic acid tablets is more effective in preventing stroke among the patients with primary hypertension when compared to enalapril maleate.
Detailed description
Primary hypertension is the most important risk factor leading to cardiovascular events. Successful management of hypertension is a key to prevent these events. Hyperhomocysteinemia (HHcy) is another independent risk factor, especially for stroke. Our team's prospective nested case-control study of 39165 subjects in China showed that incidence of cardiovascular events (especially stroke) was strongly associated with plasma level of total homocysteine (tHcy). The coexistence of hypertension and HHcy dramatically increased the risk of stroke by 25 to 30 times as compared to the subjects without the two risk factors (Graham et al, 1997). Findings from previous and our studies clearly indicate that simultaneous control of hypertension and HHcy is pivotal in reducing cardiovascular events morbidity and mortality in China.
It has been well documented that folic acid is effective in lowering the level of plasma tHcy. While controversial remains on its efficacy on preventing cardiovascular events, a study done by our team: "Efficacy of folic acid supplementation in stroke prevention: a meta-analysis" (Wang et al, 2007) provide coherent evidence that folic acid supplementation can decrease the risk of stroke by 18%, and 25% in populations where folic fortification was not issued, or used for primary prevention.
C677T gene polymorphism of 5,10-methylenetetrahydrofolate reductase (MTHFR) is one of the genetic determinators of plasma tHcy level. Observational studies showed that individuals with TT genotype tend to have high plasma tHcy and elevated risk of cardiovascular events (Cronin et al. 2005), and folic acid supplementation led to a remarkable reduction in plasma tHcy. In short, previous studies by others and by our team have provided strong rationale for our proposed trial as detailed below.
The hypothesis of the current study is that a combination of antihypertensive drug (e.g., enalapril) with folic acid is not only efficacious, but also is safe and highly cost-effective than antihypertensive (e.g., enalapril) used alone to prevent stroke in hypertensive patients.
This trial will enroll 20,000 patients with primary hypertension and with known MTHFR C677T genotype. Subjects will be first stratified by genotypes, and then randomly assigned to treatment groups. The study patients will be instructed to take orally enalapril 10 mg daily or enalapril/folic acid 10mg/0.8mg tablets daily for a maximum of 5 years. The follow-up is given every 3 months.
The incidence and time of first-time stroke episode (primary endpoint) or composite cardiovascular events are used as endpoints. They will be compared by treatment groups with and without stratification by C677T gene polymorphisms. The potential interaction between treatment groups and C677T gene polymorphisms on therapeutic efficacy will also be tested.
This will be the first and largest trial of this kind in Chinese population. The findings from this trial may have the potential to transform current clinical and public health findings into practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enalapril/folic acid | Experimental | Drug: Enalapril/folic acidA fixed combination drug is given. The dose is fixed in enalapril 10 mg / folic acid 0.8 mg per day. |
| Enalapril | Active comparator | Drug: Enalapril maleateEnalapril maleate 10 mg per day is given |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BP≥140/90 mmHg in both of the two screening visits or currently under anti-hypertension treatment
- 45 - 75 years old
- Successful determination of MTHFR C677T genotype
- For pre-menopausal women, agreed to use contraceptives during the trial
- Signed the written informed consent
Key exclusion criteria (14 listed)
- Having a history of stroke
- Having a history of myocardial infarction
- Having a history of physician diagnosed heart failure
- Post- coronary revascularization
- Severe somatic disease such as cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enalapril/folic acidAlso: Enalapril Maleate and Folic Acid TabletEnalapril/folic acid, (10mg enalapril/0.8mg folic acid)/tablet, taken orally and once daily for a maximum of 5 years. Combination with other anti-hypertension drugs are allowed. | Drug | Enalapril/folic acid |
| Enalapril maleateAlso: Lameiya,Yabao PharmaceuticalEnalapril, 10mg/tablet, taken orally once daily for a maximum of 5 consecutive years. Combination with other anti-hypertension drugs are allowed. | Drug | Enalapril |
Primary outcome
First attack of symptomatic stroke ( ischemic or hemorrhagic)
Time frame: during the trial period
Patients are followed-up every 3 months. All endpoint outcomes are assessed by the Endpoint Adjudication Committee of the study.
5 secondary outcomes
Composite major cardiovascular events
Time frame: during the trial period
All-cause death
Time frame: during the trial period
First attack of ischemic stroke and resultant death
Time frame: during the trial period
First attack of hemorrhagic stroke and resultant death
Time frame: during the trial period
Myocardial infarction and resultant death
Time frame: during the trial period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
- Background: PubMed 17544768Wang X, Qin X, Demirtas H, Li J, Mao G, Huo Y, Sun N, Liu L, Xu X. Efficacy of folic acid supplementation in stroke prevention: a meta-analysis. Lancet. 2007 Jun 2;369(9576):1876-1882. doi: 10.1016/S0140-6736(07)60854-X.
- Background: PubMed 9178790Graham IM, Daly LE, Refsum HM, Robinson K, Brattstrom LE, Ueland PM, Palma-Reis RJ, Boers GH, Sheahan RG, Israelsson B, Uiterwaal CS, Meleady R, McMaster D, Verhoef P, Witteman J, Rubba P, Bellet H, Wautrecht JC, de Valk HW, Sales Luis AC, Parrot-Rouland FM, Tan KS, Higgins I, Garcon D, Andria G, et al. Plasma homocysteine as a risk factor for vascular disease. The European Concerted Action Project. JAMA. 1997 Jun 11;277(22):1775-81. doi: 10.1001/jama.1997.03540460039030.
- Background: PubMed 15947278Cronin S, Furie KL, Kelly PJ. Dose-related association of MTHFR 677T allele with risk of ischemic stroke: evidence from a cumulative meta-analysis. Stroke. 2005 Jul;36(7):1581-7. doi: 10.1161/01.STR.0000169946.31639.af. Epub 2005 Jun 9.
- Derived from this study: PubMed 41543379Wang L, Liu Z, Zhang N, Zhang L, Liu X, Fan F, Zhang Y, Li J. Association Between Neutrophil Percentage-to-Albumin Ratio (NPAR) and Risk of Stroke in Patients With Hypertension: A Cohort Study. J Clin Hypertens (Greenwich). 2026 Jan;28(1):e70200. doi: 10.1111/jch.70200.
- Derived from this study: PubMed 39821957Zhang N, Mei J, Fan F, Zhang Y, Zhou Z, Li J. Posttreatment Blood Pressure as a Key Predictor in a 5-Year Stroke Prediction Model. J Clin Hypertens (Greenwich). 2025 Jan;27(1):e14974. doi: 10.1111/jch.14974.
- Derived from this study: PubMed 38683601Meng Y, Liu L, Chen X, Zhao L, She H, Zhang W, Zhang J, Qin X, Li J, Xu X, Wang B, Hou F, Tang G, Liao R, Huo Y, Li J, Yang L. Associations between brachial-ankle pulse wave velocity and hypertensive retinopathy in treated hypertensive adults: Results from the China Stroke Primary Prevention Trial (CSPPT). J Clin Hypertens (Greenwich). 2024 Jun;26(6):724-734. doi: 10.1111/jch.14820. Epub 2024 Apr 29.
- Derived from this study: PubMed 38092871Li W, Li C, Liu T, Song Y, Chen P, Liu L, Wang B, Qu J. The association of serum choline concentrations with the risk of cancers: a community-based nested case-control study. Sci Rep. 2023 Dec 13;13(1):22144. doi: 10.1038/s41598-023-49610-3.
- Derived from this study: PubMed 37501059Lei W, Liu Z, Su Z, Meng P, Zhou C, Chen X, Hu Z, Xiao A, Zhou M, Huang L, Zhang Y, Qin X, Wang J, Zhu F, Nie J. Hyperhomocysteinemia potentiates megakaryocyte differentiation and thrombopoiesis via GH-PI3K-Akt axis. J Hematol Oncol. 2023 Jul 27;16(1):84. doi: 10.1186/s13045-023-01481-x.
- Derived from this study: PubMed 36083982Li Y, Song Y, Liu L, Wang X, Zhou Z, Zhang N, Wang Z, Chen P, Shi H, Huo Y, Xu X, Li J. Inverse Association Between Baseline Plasma Selenium Concentrations and Risks of Renal Function Decline in Hypertensive Adults. J Nutr. 2023 Jan 14;152(12):2754-2760. doi: 10.1093/jn/nxac211.
- Derived from this study: PubMed 35903445He Q, Zhang N, Liang Q, Wang Z, Chen P, Song Y, Zhou Z, Wei Y, Duan Y, Wang B, Qin P, Qin X, Xu X. Serum Serine and the Risk of All-Cause Mortality: A Nested Case-Control Study From the China Stroke Primary Prevention Trial (CSPPT). Front Nutr. 2022 Jul 12;9:946277. doi: 10.3389/fnut.2022.946277. eCollection 2022.
- Derived from this study: PubMed 35660920Wei Y, Wang Z, He Q, Siddiqi SM, Zhou Z, Liu L, Song Y, Chen P, Li J, Zhang Y, Mao G, Wang B, Tang G, Qin X, Xu X, Huo Y, Guo H, Zhang H. Inverse Association between Plasma Phylloquinone and Risk of Ischemic Stroke in Chinese Adults with Hypertension and High BMI: A Nested Case-Control Study. J Nutr. 2022 Aug 9;152(8):1927-1935. doi: 10.1093/jn/nxac131.
- Derived from this study: PubMed 34930356Song M, Xu BP, Liang Q, Wei Y, Song Y, Chen P, Zhou Z, Zhang N, He Q, Liu L, Liu T, Zhang K, Hu C, Wang B, Xu X, Shi H. Association of serum choline levels and all-cause mortality risk in adults with hypertension: a nested case-control study. Nutr Metab (Lond). 2021 Dec 20;18(1):108. doi: 10.1186/s12986-021-00637-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Huo, M.D. principal investigator
The First Hospital, Beijing University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enalapril/folic acid and Enalapril maleate in people with Primary Hypertension, run by Shenzhen Ausa Pharmed Co.,Ltd at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First attack of symptomatic stroke ( ischemic or hemorrhagic) (time frame: during the trial period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00794885, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2014; AzTrials last refreshed its copy on 27 Oct 2026.