The purpose of this trial is to confirm that enalapril maleate and folic acid tablets is more effective in preventing stroke among the patients with primary hypertension when compared to enalapril maleate.
Name: Enalapril/folic acid
Name: Enalapril maleate
Description: Patients are followed-up every 3 months. All endpoint outcomes are assessed by the Endpoint Adjudication Committee of the study.
Measure: First attack of symptomatic stroke ( ischemic or hemorrhagic) Time: during the trial periodAllocation: Randomized
Parallel Assignment
There is one SNP
Inclusion Criteria: - BP≥140/90 mmHg in both of the two screening visits or currently under anti-hypertension treatment - 45 - 75 years old - Successful determination of MTHFR C677T genotype - For pre-menopausal women, agreed to use contraceptives during the trial - Signed the written informed consent Exclusion Criteria: - Having a history of stroke - Having a history of myocardial infarction - Having a history of physician diagnosed heart failure - Post- coronary revascularization - Severe somatic disease such as cancer - Secondary hypertension - Congenital or acquired organic heart diseases - Contraindicated to angiotensin-converting enzyme inhibitor(ACEI) - History of ACEI adverse effects - Currently long-term use of folic acid or vitamin B12 or vitamin B6 - Pregnant or child breastfeeding women - Severe mental disorders - Lab tests indicating abnormal liver or kidney function - Unwilling to participate the trial, unwilling to change the current antihypertensive treatment Inclusion Criteria: - BP≥140/90 mmHg in both of the two screening visits or currently under anti-hypertension treatment - 45 - 75 years old - Successful determination of MTHFR C677T genotype - For pre-menopausal women, agreed to use contraceptives during the trial - Signed the written informed consent Exclusion Criteria: - Having a history of stroke - Having a history of myocardial infarction - Having a history of physician diagnosed heart failure - Post- coronary revascularization - Severe somatic disease such as cancer - Secondary hypertension - Congenital or acquired organic heart diseases - Contraindicated to angiotensin-converting enzyme inhibitor(ACEI) - History of ACEI adverse effects - Currently long-term use of folic acid or vitamin B12 or vitamin B6 - Pregnant or child breastfeeding women - Severe mental disorders - Lab tests indicating abnormal liver or kidney function - Unwilling to participate the trial, unwilling to change the current antihypertensive treatment Primary Hypertension Hypertension Essential Hypertension Primary hypertension is the most important risk factor leading to cardiovascular events. --- C677T ---
Inclusion Criteria: - BP≥140/90 mmHg in both of the two screening visits or currently under anti-hypertension treatment - 45 - 75 years old - Successful determination of MTHFR C677T genotype - For pre-menopausal women, agreed to use contraceptives during the trial - Signed the written informed consent Exclusion Criteria: - Having a history of stroke - Having a history of myocardial infarction - Having a history of physician diagnosed heart failure - Post- coronary revascularization - Severe somatic disease such as cancer - Secondary hypertension - Congenital or acquired organic heart diseases - Contraindicated to angiotensin-converting enzyme inhibitor(ACEI) - History of ACEI adverse effects - Currently long-term use of folic acid or vitamin B12 or vitamin B6 - Pregnant or child breastfeeding women - Severe mental disorders - Lab tests indicating abnormal liver or kidney function - Unwilling to participate the trial, unwilling to change the current antihypertensive treatment Inclusion Criteria: - BP≥140/90 mmHg in both of the two screening visits or currently under anti-hypertension treatment - 45 - 75 years old - Successful determination of MTHFR C677T genotype - For pre-menopausal women, agreed to use contraceptives during the trial - Signed the written informed consent Exclusion Criteria: - Having a history of stroke - Having a history of myocardial infarction - Having a history of physician diagnosed heart failure - Post- coronary revascularization - Severe somatic disease such as cancer - Secondary hypertension - Congenital or acquired organic heart diseases - Contraindicated to angiotensin-converting enzyme inhibitor(ACEI) - History of ACEI adverse effects - Currently long-term use of folic acid or vitamin B12 or vitamin B6 - Pregnant or child breastfeeding women - Severe mental disorders - Lab tests indicating abnormal liver or kidney function - Unwilling to participate the trial, unwilling to change the current antihypertensive treatment Primary Hypertension Hypertension Essential Hypertension Primary hypertension is the most important risk factor leading to cardiovascular events. --- C677T --- --- C677T ---
C677T gene polymorphism of 5,10-methylenetetrahydrofolate reductase (MTHFR) is one of the genetic determinators of plasma tHcy level. --- C677T ---
This trial will enroll 20,000 patients with primary hypertension and with known MTHFR C677T genotype. --- C677T ---
They will be compared by treatment groups with and without stratification by C677T gene polymorphisms. --- C677T ---
The potential interaction between treatment groups and C677T gene polymorphisms on therapeutic efficacy will also be tested. --- C677T ---