[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100452247":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":46,"centralContacts":50,"locations":60,"responsibleParty":75,"collaborators":35,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":35,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":103,"whyStopped":35,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Amlodipine folic acid 5.8mg+intensive antihypertensive therapy","ACTIVE_COMPARATOR","This group will receive intensive antihypertensive therapy (systolic blood pressure(SBP) \\\u003C130 mmHg); with amlodipine folic acid 5.8mg.",[13],"Drug: Amlodipine folic acid 5.8mg+intensive antihypertensive therapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Amlodipine folic acid 5.8mg+standard antihypertensive therapy","This group will receive standard antihypertensive therapy (SBP: 130-140 mmHg); with amlodipine folic acid 5.8mg.",[18],"Drug: Amlodipine folic acid 5.8mg+standard antihypertensive therapy",{"label":20,"type":10,"description":21,"interventionNames":22},"Amlodipine+intensive antihypertensive therapy","This group will receive intensive antihypertensive therapy (systolic blood pressure(SBP) \\\u003C130 mmHg); with amlodipine 5.0mg.",[23],"Drug: Amlodipine+intensive antihypertensive therapy",{"label":25,"type":26,"description":27,"interventionNames":28},"Amlodipine+standard antihypertensive therapy","PLACEBO_COMPARATOR","This group will receive standard antihypertensive therapy (SBP: 130-140 mmHg); with amlodipine 5.0mg.",[29],"Drug: Amlodipine+standard antihypertensive therapy",[31,36,39,42],{"type":32,"name":9,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Amlodipine folic acid tablet 5.8mg, taken daily, in the morning after waking.\n\nTo achieve target blood pressure(SBP\\\u003C130mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below:\n\n1. Add candesartan 4mg;\n2. Add indapamide 2.5mg;\n3. Increase dose of candesartan to 8mg;\n4. Increase dose of amlodipine to 7.5mg-10mg.",[9],null,{"type":32,"name":15,"description":37,"armGroupLabels":38,"otherNames":35},"Amlodipine folic acid tablet 5.8mg, taken daily, in the morning after waking.\n\nTo achieve target blood pressure (SBP:130-140mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below:\n\n1. Add candesartan 4mg;\n2. Add indapamide 2.5mg;\n3. Increase dose of candesartan to 8mg;\n4. Increase dose of amlodipine to 7.5mg-10mg.",[15],{"type":32,"name":20,"description":40,"armGroupLabels":41,"otherNames":35},"Amlodipine tablet 5.8mg, taken daily, in the morning after waking.\n\nTo achieve target blood pressure (SBP: 130-140 mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below:\n\n1. Add candesartan 4mg;\n2. Add indapamide 2.5mg;\n3. Increase dose of candesartan to 8mg;\n4. Increase dose of amlodipine to 7.5mg-10mg.",[20],{"type":32,"name":25,"description":40,"armGroupLabels":43,"otherNames":44},[25],[45],"Standard antihypertensive therapy",[47],{"name":48,"affiliation":5,"role":49},"Yongjun Wang","PRINCIPAL_INVESTIGATOR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":35,"email":55},"Jinglin Mo","CONTACT","+86 18801125231","mojinglin_dmu@163.com",{"name":57,"role":53,"phone":58,"phoneExt":35,"email":59},"Anxin Wang","0086-010-59978350","anxin0907@163.com",[61],{"facility":5,"status":35,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Beijing","Beijing Municipality","100070","China","CN",{"type":68,"coordinates":69},"Point",[70,71],116.39723,39.9075,{"lat":71,"lon":70},[74],{"name":52,"role":53,"phone":54,"phoneExt":35,"email":55},{"type":49,"investigatorFullName":48,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"President of Beijing Tiantan Hospital, Capital Medical University","100452247","phase-4-folic-acid-and-intensive-antihypertensive-therapy-for-hypertension-with-csvd-100452247",false,"NCT05169021","Folic Acid and Intensive Antihypertensive Therapy for Hypertension With CSVD","Folic Acid and Intensive Antihypertensive Therapy for Cerebrovascular and Cardiovascular Events Prevention Among Patients With Hypertension and Cerebral Small Vascular Diseases (FAITH)----A Multicenter, Randomized, Controlled, Open-label, 2x2 Factorial, Blinded End-point Trial","FAITH","Inclusion Criteria:\n\n1. Age 35-75 years;\n2. Meets any of the following criteria:\n\n1\\) Lacunar infarction occurring within the period of seven days up to one year post-infarction, diagnosed by head MRI\u002FCT (meeting modified Fisher criteria\\*); 2）Head MRI indicating white matter hyperintensity, 4≥Fazekas score\\*≥2; 3）Head MRI indicating white matter hyperintensity, Fazekas=1, combined with old subcortical vascular lacunar infarction;\n\n* For modified Fisher criteria and Fazekas score, see FAITH main study appendix 1 and appendix 6).\n\n  3\\. Medical recorded history of hypertension. Systolic blood pressure SBP: 130-180 mm Hg on 0 or 1 medication SBP: 130-170 mm Hg on up to 2 medications SBP: 130-160 mm Hg on up to 3 medications. 4. mRS score ≤2; 5. Serum Hcy ≥10 µmol\u002FL or MTHFR 677 TT genotype; 6. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Patients with secondary hypertension;\n2. Symptomatic intracranial and extracranial artery stenosis (stenosis ≥50%), or asymptomatic intracranial and extracranial artery stenosis (stenosis≥70%);\n3. Patients who have undergone revascularization of the heart, brain, or kidney, or other aortic stenting procedures;\n4. Any symptoms of orthostatic hypotension when measuring standing blood pressure, or if standing SBP \\\u003C110mmHg;\n5. Bilateral renal artery stenosis;\n6. Patients who have previously taken candesartan or other angiotensin receptor antagonist (ARB) type medication, indapamide or other similar diuretic type medication, or any medication or health product containing folic acid, and reported adverse reactions;\n7. Patients who have indicators for specific antihypertensive medications (e.g. β-blockers after acute myocardial infarction, RAS blockers for prevention of cardiovascular disease, α-blockers for treatment of benign prostate hyperplasia);\n8. Within the last three months, regular usage of vitamin supplements containing folic acid, B6, or B12, or usage of folic acid antagonists (e.g. methotrexate);\n9. Patients undergoing dialysis or with stage 4-5 chronic kidney disease, or estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m²;\n10. History of epilepsy or currently using anti-epileptic medication;\n11. Pregnant and lactating women, or women planning to become pregnant;\n12. Life expectancy less than four years;\n13. Within the last month, participation in another clinical trial;\n14. Any patient determined by the researchers to be unsuitable for the present study.","ALL","35 Years","75 Years",{"count":89,"type":90},15000,"ESTIMATED","INTERVENTIONAL",[93],"PHASE4","The primary objectives of this trial are:\n\n1. Efficacy evaluation of amlodipine folic acid tablets:\n\n   To assess the effects of amlodipine folic acid tablets 5.8 mg (5 mg amlodipine + 0.8 mg folic acid)versus amlodipine tablets 5 mg in preventing all-cause stroke in cerebral small vascular disease (CSVD) patients with hypertension and elevated homocysteine (Hcy) level.\n2. Intensive Antihypertensive Therapy:\n\nTo assess the effect of intensive antihypertensive therapy (SBP\\\u003C130 mmHg) versus standard antihypertensive therapy (SBP 130-\\\u003C140 mmHg) in reducing risk of combined cardio-cerebrovascular events in CSVD patients with hypertension and elevated Hcy level, using two basic anti-hypertensive drugs, amlodipine tablets 5 mg or amlodipine folic acid tablets 5.8 mg.",[96,97],"Cerebral Small Vessel Diseases","Stroke",[96,99,100,101,102],"Stroke recurrence","Hypertension","Homocysteine","Folic acid","NOT_YET_RECRUITING","2021-12-10",{"date":106,"type":107},"2021-12-23","ACTUAL",{"date":109,"type":90},"2021-12-31",{"date":111,"type":90},"2028-12-31",{"name":5,"class":6},1]