Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-31 @ 12:46 PM
Study NCT ID:
NCT04974151
Status:
RECRUITING
Last Update Posted:
2025-02-26
First Post:
2021-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'C005984', 'term': '5-methyltetrahydrofolate'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter, randomized, controlled, double-blind, triple-dummy clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2021-07-13', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Malignant tumors', 'timeFrame': 'By the end of the fifth year of the study', 'description': 'We will examine whether there exist significant differences in efficacy in reducing the risk of malignant tumors between the Groups B + C and Group A.'}, {'measure': 'All-cause mortality', 'timeFrame': 'By the end of the fifth year of the study', 'description': 'We will examine whether there exist significant differences in efficacy in reducing the risk of all-cause mortality between the Groups B + C and Group A.'}, {'measure': 'Blood pressure levels', 'timeFrame': '1) Blood pressure levels at one year, three-year and at the end of follow-up(up to 5 years). 2) Average blood pressure levels across all visits in the first and third years of follow-up, as well as for the entire follow-up period (up to 5 years).', 'description': 'We will examine whether there exist significant differences in treatment efficacy on the blood pressure levels between the following pairs of treatment groups:\n\nGroups B + C vs. Group A\n\nGroup B vs. Group A\n\nGroup C vs. Group A\n\nGroup B vs. Group C'}, {'measure': 'Blood pressure variability', 'timeFrame': '1) Average blood pressure variability across all visits in the first and third years of follow-up, and across all visits throughout the entire follow-up period (up to 5 years).', 'description': 'We will examine whether there exist significant differences in treatment efficacy on the blood pressure variability between the following pairs of treatment groups:\n\nGroups B + C vs. Group A\n\nGroup B vs. Group A\n\nGroup C vs. Group A\n\nGroup B vs. Group C'}, {'measure': 'Blood pressure target achievement rates', 'timeFrame': '1) Blood pressure target achievementrates at 1-year, 3-year and at the end of follow-up(up to 5 years). 2) Average bloodpressure target achievement rates across all visits in the first and third years of follow-up, and for the entire follow-up period.]', 'description': 'We will examine whether there exist significant differences in treatment efficacy on the blood pressure target achievement rates between the following pairs of treatment groups:\n\nGroups B + C vs. Group A\n\nGroup B vs. Group A\n\nGroup C vs. Group A\n\nGroup B vs. Group C'}, {'measure': 'Serum folate level', 'timeFrame': 'Serum folate levels at one year, three-year and at the end of follow-up(up to 5 years).', 'description': 'We will examine whether there exist significant differences in treatment efficacy on the serum folate levels between the following pairs of treatment groups:\n\nGroups B + C vs. Group A\n\nGroup B vs. Group A\n\nGroup C vs. Group A\n\nGroup B vs. Group C'}, {'measure': 'Serum folate change', 'timeFrame': 'Serum folate changes at one year, three-year and at the end of follow-up(up to 5 years).', 'description': 'We will examine whether there exist significant differences in treatment efficacy on the serum folate changes between the following pairs of treatment groups:\n\nGroups B + C vs. Group A\n\nGroup B vs. Group A\n\nGroup C vs. Group A\n\nGroup B vs. Group C'}, {'measure': 'Plasma tHcy level', 'timeFrame': 'Plasma total homocysteine levels at one year, three-year and at the end of follow-up(up to 5 years).', 'description': 'We will examine whether there exist significant differences in treatment efficacy on the plasma total homocysteine levels between the following pairs of treatment groups:\n\nGroups B + C vs. Group A\n\nGroup B vs. Group A\n\nGroup C vs. Group A\n\nGroup B vs. Group C'}, {'measure': 'Plasma tHcy change', 'timeFrame': 'Plasma total homocysteine changes at one year, three-year and at the end of follow-up(up to 5 years).', 'description': 'We will examine whether there exist significant differences in treatment efficacy on the plasma total homocysteine changes between the following pairs of treatment groups:\n\nGroups B + C vs. Group A\n\nGroup B vs. Group A\n\nGroup C vs. Group A\n\nGroup B vs. Group C'}], 'primaryOutcomes': [{'measure': 'First ischemic stroke', 'timeFrame': 'By the end of the fifth year of the study', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'First ischemic stroke (for refined treatment group comparisons)', 'timeFrame': 'By the end of the fifth year of the study', 'description': '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:\n\nGroup B vs. Group A\n\nGroup C vs. Group A\n\nGroup B vs. Group C'}, {'measure': 'First stroke (ischemic and hemorrhagic)', 'timeFrame': 'By the end of the fifth year from baseline', 'description': 'We will examine whether there exist significant differences in efficacy in reducing the risk of first stroke between the following pairs of treatment groups:\n\nGroups B + C vs. Group A\n\nGroup B vs. Group A\n\nGroup C vs. Group A\n\nGroup B vs. Group C'}, {'measure': 'Composite cardiovascular endpoint (first non-fatal stroke, first non-fatal myocardial infarction, cardiovascular death)', 'timeFrame': 'By the end of the fifth year from baseline', 'description': '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:\n\nGroups B + C vs. Group A\n\nGroup B vs. Group A\n\nGroup C vs. Group A\n\nGroup B vs. Group C'}, {'measure': 'Kidney outcomes', 'timeFrame': 'By the end of the fifth year from baseline', 'description': '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).\n2. 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.\n\nWe will examine whether there exist significant differences in treatment efficacy on the above kidney endpoints between the following pairs of treatment groups:\n\nGroups B + C vs. Group A\n\nGroup B vs. Group A\n\nGroup C vs. Group A\n\nGroup B vs. Group C'}, {'measure': 'First hemorrhagic stroke', 'timeFrame': 'By the end of the fifth year from baseline', 'description': '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.'}, {'measure': 'First myocardial infarction', 'timeFrame': 'By the end of the fifth year from baseline', 'description': '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.'}, {'measure': 'First coronary revascularization (coronary artery bypass grafting [CABG] or percutaneous coronary intervention [PCI])', 'timeFrame': 'By the end of the fifth year from baseline', 'description': '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.'}, {'measure': 'Cardiovascular death', 'timeFrame': 'By the end of the fifth year from baseline', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Folic acid', 'Homocysteine', 'MTHFR 677 TT genotype', 'Randomized controlled trial', 'Ischemic stroke', '5-MTHF'], 'conditions': ['Hypertension', 'MTHFR 677 TT Genotype']}, 'referencesModule': {'references': [{'pmid': '11800055', 'type': 'BACKGROUND', 'citation': 'Kjeldsen SE, Julius S, Hedner T, Hansson L. Stroke is more common than myocardial infarction in hypertension: analysis based on 11 major randomized intervention trials. Blood Press. 2001;10(4):190-2. doi: 10.1080/08037050152669684. No abstract available.'}, {'pmid': '9569395', 'type': 'BACKGROUND', 'citation': "Collaboration HLT. Lowering blood homocysteine with folic acid based supplements: meta-analysis of randomised trials. Homocysteine Lowering Trialists' Collaboration. BMJ. 1998 Mar 21;316(7135):894-8."}, {'pmid': '16210710', 'type': 'BACKGROUND', 'citation': "Homocysteine Lowering Trialists' Collaboration. Dose-dependent effects of folic acid on blood concentrations of homocysteine: a meta-analysis of the randomized trials. Am J Clin Nutr. 2005 Oct;82(4):806-12. doi: 10.1093/ajcn/82.4.806."}, {'pmid': '12920077', 'type': 'BACKGROUND', 'citation': 'Wilcken B, Bamforth F, Li Z, Zhu H, Ritvanen A, Renlund M, Stoll C, Alembik Y, Dott B, Czeizel AE, Gelman-Kohan Z, Scarano G, Bianca S, Ettore G, Tenconi R, Bellato S, Scala I, Mutchinick OM, Lopez MA, de Walle H, Hofstra R, Joutchenko L, Kavteladze L, Bermejo E, Martinez-Frias ML, Gallagher M, Erickson JD, Vollset SE, Mastroiacovo P, Andria G, Botto LD. Geographical and ethnic variation of the 677C>T allele of 5,10 methylenetetrahydrofolate reductase (MTHFR): findings from over 7000 newborns from 16 areas world wide. J Med Genet. 2003 Aug;40(8):619-25. doi: 10.1136/jmg.40.8.619. No abstract available.'}, {'pmid': '22230384', 'type': 'BACKGROUND', 'citation': 'Qin X, Li J, Cui Y, Liu Z, Zhao Z, Ge J, Guan D, Hu J, Wang Y, Zhang F, Xu X, Wang X, Xu X, Huo Y. MTHFR C677T and MTR A2756G polymorphisms and the homocysteine lowering efficacy of different doses of folic acid in hypertensive Chinese adults. Nutr J. 2012 Jan 10;11:2. doi: 10.1186/1475-2891-11-2.'}, {'pmid': '21869730', 'type': 'BACKGROUND', 'citation': 'Qin X, Li J, Cui Y, Liu Z, Zhao Z, Ge J, Guan D, Hu J, Wang Y, Zhang F, Xu X, Wang X, Xu X, Huo Y. Effect of folic acid intervention on the change of serum folate level in hypertensive Chinese adults: do methylenetetrahydrofolate reductase and methionine synthase gene polymorphisms affect therapeutic responses? Pharmacogenet Genomics. 2012 Jun;22(6):421-8. doi: 10.1097/FPC.0b013e32834ac5e8.'}, {'pmid': '18511872', 'type': 'BACKGROUND', 'citation': 'Xu X, Li J, Sheng W, Liu L. Meta-analysis of genetic studies from journals published in China of ischemic stroke in the Han Chinese population. Cerebrovasc Dis. 2008;26(1):48-62. doi: 10.1159/000135653. Epub 2008 May 30.'}, {'pmid': '22880024', 'type': 'BACKGROUND', 'citation': 'Qin X, Li J, Zhang Y, Ma W, Fan F, Wang B, Xing H, Tang G, Wang X, Xu X, Xu X, Huo Y. Prevalence and associated factors of diabetes and impaired fasting glucose in Chinese hypertensive adults aged 45 to 75 years. PLoS One. 2012;7(8):e42538. doi: 10.1371/journal.pone.0042538. Epub 2012 Aug 3.'}, {'pmid': '22897803', 'type': 'BACKGROUND', 'citation': 'Dong Q, Tang G, He M, Cai Y, Cai Y, Xing H, Sun L, Li J, Zhang Y, Fan F, Wang B, Sun N, Liu L, Xu X, Hou F, Shen H, Xu X, Huo Y. Methylenetetrahydrofolate reductase C677T polymorphism is associated with estimated glomerular filtration rate in hypertensive Chinese males. BMC Med Genet. 2012 Aug 16;13:74. doi: 10.1186/1471-2350-13-74.'}, {'pmid': '25771069', 'type': 'BACKGROUND', 'citation': 'Huo Y, Li J, Qin X, Huang Y, Wang X, Gottesman RF, Tang G, Wang B, Chen D, He M, Fu J, Cai Y, Shi X, Zhang Y, Cui Y, Sun N, Li X, Cheng X, Wang J, Yang X, Yang T, Xiao C, Zhao G, Dong Q, Zhu D, Wang X, Ge J, Zhao L, Hu D, Liu L, Hou FF; CSPPT Investigators. Efficacy of folic acid therapy in primary prevention of stroke among adults with hypertension in China: the CSPPT randomized clinical trial. JAMA. 2015 Apr 7;313(13):1325-35. doi: 10.1001/jama.2015.2274.'}, {'pmid': '29030456', 'type': 'BACKGROUND', 'citation': 'Huang X, Li Y, Li P, Li J, Bao H, Zhang Y, Wang B, Sun N, Wang J, He M, Yin D, Tang G, Chen Y, Cui Y, Huang Y, Hou FF, Qin X, Huo Y, Cheng X. Association between percent decline in serum total homocysteine and risk of first stroke. Neurology. 2017 Nov 14;89(20):2101-2107. doi: 10.1212/WNL.0000000000004648. Epub 2017 Oct 13.'}, {'pmid': '27834686', 'type': 'BACKGROUND', 'citation': 'Qin X, Li Y, Sun N, Wang H, Zhang Y, Wang J, Li J, Xu X, Liang M, Nie J, Wang B, Cheng X, Li N, Sun Y, Zhao L, Wang X, Hou FF, Huo Y. Elevated Homocysteine Concentrations Decrease the Antihypertensive Effect of Angiotensin-Converting Enzyme Inhibitors in Hypertensive Patients. Arterioscler Thromb Vasc Biol. 2017 Jan;37(1):166-172. doi: 10.1161/ATVBAHA.116.308515. Epub 2016 Nov 10.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe study participants will be randomized to one of the three treatment groups:\n\nGroup A: amlodipine tablet (5mg), taken orally, once daily, serving as active comparator.\n\nGroup B: amlodipine folic acid 5.8mg tablet (5mg amlodipine and 0.8mg folic acid), taken orally, once daily.\n\nGroup C: amlodipine folic acid 5.8mg tablet plus 5-methyltetrahydrofolate (5-MTHF, 0.4mg), taken orally, once daily.\n\nThe primary endpoint is first ischemic stroke.', 'detailedDescription': "This study consists of 3 periods: Screening, Run-in, and Randomized treatment.\n\nPeriod I: Screening (V0)\n\nThe purpose of Period I is to obtain informed consent and screen for eligible participants.\n\nAfter 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.\n\nPeriod II: Run-in Period (VD)\n\nThe 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.\n\nThe run-in phase lasted 2 to 4 weeks, during which oral administration of Amlodipine tablets (5 mg) was given once daily.\n\nPeriod III: Randomized Treatment (V1-V21)\n\nThis 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:\n\nA. Amlodipine-only (5mg/d) with an amlodipine folic acid placebo and 5-MTHF placebos.\n\nB. Amlodipine folic acid tablet (5.8mg/d) with amlodipine placebo and 5-MTHF placebo.\n\nC. 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.\n\nDuring 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.\n\nA 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).\n\nThere 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Men and women, aged ≥45 and \\<75 years.\n2. Hypertension: Previously diagnosed with primary hypertension and has been taking antihypertensive medication within the past two weeks; OR has not been taking antihypertensive medications within the last two weeks, but meets the following criteria for hypertension: SBP≥140 mmHg and/or DBP≥90 mmHg (average of at least 2 measurements each time) at two separate (not on the same day) clinical visits.\n3. MTHFR 677 TT genotype (based on the test results from the central laboratory during the screening period or a previous official test report from a laboratory with medical testing qualifications).\n4. Voluntarily participates and has given signed informed consent.\n\nRandomized-treatment phase inclusion criteria:\n\n1. Good compliance during the run-in period, and unlikely to discontinue treatment;\n2. No stroke or cardiovascular events during the run-in period;\n3. The participant voluntarily agrees to continue the study.\n\nExclusion Criteria:\n\n1. Previously diagnosed secondary hypertension;\n2. Previously diagnosed stroke;\n3. Previously diagnosed myocardial infarction;\n4. Previously diagnosed heart failure;\n5. Previously diagnosed atrial fibrillation;\n6. Cardio-cerebral-kidney revascularization and/or other large arterial stent;\n7. Currently on dialysis, or diagnosed with stage 4-5 chronic kidney disease, or eGFR \\<30 mL/ min/1.73m²;\n8. Known to have congenital (such as aortic stenosis) or acquired organic heart disease;\n9. Known to have any of the following severe diseases or conditions:\n\n 1. Digestive system: i. Previously diagnosed with any form of viral hepatitis that is currently still in the active phase; ii. Abnormal liver function test before enrollment (any of ALT, AST, GGT, TBIL, DBIL test 3 times higher than normal, or ALB≤30g/L); iii. Subtotal gastrectomy and/or gastrojejunostomy;\n 2. Respiratory system: previously diagnosed with pulmonary heart disease;\n 3. Presence of malignant tumors or other severe diseases;\n 4. Presence of long-term gastrointestinal symptoms such as ; anorexia, decreased appetite, nausea, and abdominal bloating;\n 5. Previously diagnosed with vitamin B12 deficiency and/or its related diseases.\n10. Participant, at the investigator's discretion, is assessed to be unsuitable for the study, for reasons including but not limited to the presence of abnormal laboratory results, or clinical conditions;\n11. Prior history of significant intolerance due to adverse reactions resulting from usage of amlodipine or other CCBs, valsartan or other ARBs, indapamide or other similar diuretics, metoprolol tartaric acid or other beta-blockers, or any drugs or health products containing folate or folic acid;\n12. Regular consumption of folic acid or vitamin B compounds, or other compounds containing folic acid in the past 3 months;\n13. The presence of any of the following conditions that could negatively influence a participant's ability to consent or participate in the trial:\n\n 1. Dementia;\n 2. Severe mental disorders;\n 3. Inability to express informed consent;\n 4. Unlikely to complete the study follow-up as specified by the protocol, or plans to relocate outside of the study area in the near future;\n 5. History of poor compliance when taking antihypertensive medications or is expected to have poor compliance during the study;\n14. Refusal to participate, or inability to modify current drug regimen;\n15. Women who are pregnant or breastfeeding; or subjects of childbearing potential who are unwilling or unable to use effective contraception during the study period.\n16. Within one month prior to the first visit, having participated in any clinical trial for a drug that has not yet been officially approved by the state or is not currently approved for sale; or currently participating in any clinical trial that could potentially impact the results of this study (medication use, drug efficacy, drug interaction, etc.)."}, 'identificationModule': {'nctId': 'NCT04974151', 'acronym': 'CSPPT2-TT', 'briefTitle': 'China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shenzhen Ausa Pharmed Co.,Ltd'}, 'officialTitle': 'Comparative Efficacy of Amlodipine Folic Acid vs. Amlodipine on the Risk of First Ischemic Stroke Among Participants With Hypertension and MTHFR 677 TT Genotype: A Multi-center, Randomized, Double-blind, Triple-dummy, Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'CSPPT2-TT_2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Amlodipine (5mg/d)', 'description': 'Amlodipine 5mg x1 tablet + Amlodipine folic acid (dummy) x1 tablet + 5-MTHF (dummy) x2 tablets, taken orally, in the morning after waking up.\n\nAmlodipine tablets, amlodipine folic acid placebos, and 5-MTHF placebos are provided in aluminum-plastic blister plate. Each package includes 100 days of treatment drug (including 10 extra days of treatment for the follow-up window). A package of medication consists of 50 plates, each plate includes a total of 8 tablets arranged as follows: amlodipine 5mg x2 tablets + amlodipine folic acid (dummy) x2 tablets + 5-MTHF (dummy) x4 tablets. Affixed to the package is the randomized treatment drug label (400 tablets/package, 4 tablets/day).', 'interventionNames': ['Drug: Amlodipine besylate', 'Drug: Amlodipine folic acid placebo', 'Drug: 5-MTHF Placebos']}, {'type': 'EXPERIMENTAL', 'label': 'Amlodipine folic acid (5.8mg/d)', 'description': 'Amlodipine folic acid 5.8mg x1 tablet + amlodipine (dummy) x1 tablet + 5-MTHF (dummy) x2 tablets, taken orally, in the morning after waking up.\n\nAmlodipine folic acid tablets, amlodipine placebos, and 5-MTHF placebos are provided in aluminum-plastic blister plate. Each package includes 100 days of treatment drug (including 10 extra days of treatment for the follow-up window). A package of medication consists of 50 plates, each plate includes a total of 8 tablets arranged as follows: amlodipine folic acid 5.8mg x2 tablets + amlodipine (dummy) x2 tablets + 5-MTHF (dummy) x4 tablets. Affixed to the package is the randomized treatment drug label (400 tablets/package, 4 tablets/day).', 'interventionNames': ['Drug: Amlodipine besylate And Folic Acid', 'Drug: Amlodipine placebo', 'Drug: 5-MTHF Placebos']}, {'type': 'EXPERIMENTAL', 'label': 'Amlodipine folic acid (5.8mg/d) + 5-MTHF (0.4mg/d)', 'description': 'Amlodipine folic acid 5.8mg x1 tablet + 5-methyltetrahydrofolate 0.2mg x2 tablets + amlodipine (dummy) x1 tablet, taken orally, in the morning after waking up.\n\nAmlodipine folic acid tablets, 5-MTHF, and amlodipine placebos are provided in aluminum-plastic blister plate. Each package includes 100 days of treatment drug (including 10 extra days of treatment for the follow-up window). A package of medication consists of 50 plates, each plate includes a total of 8 tablets arranged as follows: amlodipine folic acid 5.8mg x2 tablets + amlodipine (dummy) x2 tablets + 5-MTHF, 0.2mg x4 tablets. Affixed to the package is the randomized treatment drug label (400 tablets/package, 4 tablets/day).', 'interventionNames': ['Drug: Amlodipine besylate And Folic Acid', 'Drug: 5-methyltetrahydrofolate (5-MTHF)', 'Drug: Amlodipine placebo']}], 'interventions': [{'name': 'Amlodipine besylate', 'type': 'DRUG', 'otherNames': ['Amlodipine'], 'description': 'The amlodipine used in this study is a listed product.', 'armGroupLabels': ['Amlodipine (5mg/d)']}, {'name': 'Amlodipine besylate And Folic Acid', 'type': 'DRUG', 'otherNames': ['Amlodipine Folic Acid', 'Anye'], 'description': 'The amlodipine besylate and folic acid tablets have been approved for listing by the China Food and Drug Administration, approval number: Zhunzi H20180020.', 'armGroupLabels': ['Amlodipine folic acid (5.8mg/d)', 'Amlodipine folic acid (5.8mg/d) + 5-MTHF (0.4mg/d)']}, {'name': '5-methyltetrahydrofolate (5-MTHF)', 'type': 'DRUG', 'otherNames': ['5-MTHF'], 'description': 'The 5-MTHF used in this study is a listed product.', 'armGroupLabels': ['Amlodipine folic acid (5.8mg/d) + 5-MTHF (0.4mg/d)']}, {'name': 'Amlodipine placebo', 'type': 'DRUG', 'otherNames': ['Amlodipine (dummy)'], 'description': 'Amlodipine placebos are dummy pills of amlodipine with identical appearance.', 'armGroupLabels': ['Amlodipine folic acid (5.8mg/d)', 'Amlodipine folic acid (5.8mg/d) + 5-MTHF (0.4mg/d)']}, {'name': 'Amlodipine folic acid placebo', 'type': 'DRUG', 'otherNames': ['Amlodipine folic acid (dummy)'], 'description': 'Amlodipine folic acid placebos are dummy pills of amlodipine folic acid with identical appearance.', 'armGroupLabels': ['Amlodipine (5mg/d)']}, {'name': '5-MTHF Placebos', 'type': 'DRUG', 'otherNames': ['5-MTHF (dummy)'], 'description': '5-MTHF placebos are the dummy pills of 5-MTHF with identical appearance.', 'armGroupLabels': ['Amlodipine (5mg/d)', 'Amlodipine folic acid (5.8mg/d)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '233004', 'city': 'Bengbu', 'state': 'Anhui', 'status': 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