Folic Acid and Intensive Antihypertensive Therapy for Hypertension With CSVD
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age35-75
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Age 35-75 years;
For modified Fisher criteria and Fazekas score, see FAITH main study appendix 1 and appendix 6).
Disqualifiers
Patients with secondary hypertension;
Symptomatic intracranial and extracranial artery stenosis (stenosis ≥50%), or asymptomatic intracranial and extracranial artery stenosis (stenosis≥70%);
Patients who have undergone revascularization of the heart, brain, or kidney, or other aortic stenting procedures;
Any symptoms of orthostatic hypotension when measuring standing blood pressure, or if standing SBP <110mmHg;
Trial design
Treatments tested in this trial
- Amlodipine folic acid 5.8mg+intensive antihypertensive therapy
- Amlodipine folic acid 5.8mg+standard antihypertensive therapy
- Amlodipine+intensive antihypertensive therapy
- Amlodipine+standard antihypertensive therapy
Treatment groups
15,000 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov