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Folic Acid and Intensive Antihypertensive Therapy for Hypertension With CSVD

Study acronym: FAITH
StatusNot Yet Recruiting
PhasePhase 4
Started2021-12-31
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 23, 2021 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.
Beijing Tiantan Hospital
280 trials monitored
See 4 trials at risk
Stroke
3,268 trials monitored
See 122 trials at risk
The primary objectives of this trial are: 1. Efficacy evaluation of amlodipine folic acid tablets: 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. 2. Intensive Antihypertensive Therapy: To assess the effect of intensive antihypertensive therapy (SBP\<130 mmHg) versus standard antihypertensive therapy (SBP 130-\<140 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.
Trial Details
NCT Number NCT05169021
Lead Sponsor Beijing Tiantan Hospital
Conditions Cerebral Small Vessel Diseases, Stroke
Enrollment 15,000 participants
Start Date 2021-12-31
Primary Completion 2024-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2021-12-23