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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Amlodipine folic acid 5.8mg+intensive antihypertensive therapy
DrugAmlodipine folic acid tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure(SBP\<130mmHg), 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: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.
Amlodipine folic acid 5.8mg+standard antihypertensive therapy
DrugAmlodipine folic acid tablet 5.8mg, taken daily, in the morning after waking. To 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: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.
Amlodipine+intensive antihypertensive therapy
DrugAmlodipine tablet 5.8mg, taken daily, in the morning after waking. To 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: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.
Amlodipine+standard antihypertensive therapy
DrugAmlodipine tablet 5.8mg, taken daily, in the morning after waking. To 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: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.
Treatment groups
15,000 Participants
are divided into 4 treatment groupsGroup A: Amlodipine folic acid 5.8mg+intensive antihypertensive therapyActive comparator 1 intervention
Group B: Amlodipine folic acid 5.8mg+standard antihypertensive therapyActive comparator 1 intervention
Group C: Amlodipine+intensive antihypertensive therapyActive comparator 1 intervention
Group D: Amlodipine+standard antihypertensive therapyPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
All-cause stroke (including fatal and non-fatal stroke)
This aims 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 stroke occurrence in cerebral small vascular disease (CSVD) patients with hypertension and elevated homocysteine (Hcy) level
Time frame
4 year after randomization2
Combined cardio-cerebrovascular events
This aims 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.
Time frame
4 year after randomizationSecondary outcomes
1
Combined cardio-cerebrovascular events
Secondary outcome for assessing 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 combined cardio-cerebrovascular events in cerebral small vascular disease (CSVD) patients with hypertension and elevated homocysteine (Hcy) level.
Time frame
4 year after randomization2
All-cause stroke (including fatal and non-fatal stroke)
Secondary outcome for assessing the effect of intensive antihypertensive therapy (SBP\<130 mmHg) versus standard antihypertensive therapy (SBP 130-\<140 mmHg) in reducing risk of stroke occurrence in CSVD patients with hypertension and elevated Hcy level.
Time frame
4 year after randomization3
Ischemic stroke
Percentage of patients within follow-up period new ischemic stroke events.
Time frame
4 year after randomization4
Hemorrhagic stroke
Percentage of patients within follow-up period new hemorrhagic stroke events.
Time frame
4 year after randomizationOther outcomes
1
Malignant tumors occurence
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 malignant tumors occurrence in cerebral small vascular disease (CSVD) patients with hypertension and elevated homocysteine (Hcy) level.
Time frame
4 year after randomization2
Changes in total image load score of CSVD
Changes in total image load score of CSVD
Time frame
4 year after randomization3
Changes in WMLs and brain volume
Changes in WMLs and brain volume
Time frame
4 year after randomization4
Changes in score of each single item of the grading of CSVD image load
Changes in score of each single item of the grading of CSVD image load
Time frame
4 year after randomizationSponsors and contacts
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Source ClinicalTrials.gov
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