Enalapril Folic Acid Tablets Combined With CCB or Diuretic to Prevent Stroke in Patients With Type H Hypertension

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Enalapril Folic Acid Tablets Combined With amlodipine; Drug: Enalapril Folic Acid Tablets Combined With hydrochlorothiazide

• Registration Number: NCT04952051
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

Hypertension is a common condition that can cause serious events such as stroke, coronary heart disease and heart failure. Homocysteine (Hcy) is a substance in the body that is harmful to blood vessels. Hyperhomocysteinemia (plasma Hcy≥10 mol/L), which is associated with hypertension, significantly increases the risk of stroke. This type of high blood pressure is called type "H" hypertension. Enalapril folic acid tablet is an innovative drug developed independently in China and is the first choice for the treatment of H type hypertension. Patients with type H hypertension should be treated with enalapril folic acid tablets to reduce stroke.

However, some patients had poor blood pressure control after monotherapy. At this time, other antihypertensive drugs should be used in combination. Amlodipine and Hydrochlorothiazide are the most commonly used and the best combination.

The purpose of this study was to observe the difference in the efficacy of enalapril folic acid tablets in patients with uncontrolled blood pressure who were well tolerated and randomized to aminoclodipine or hydrochlorothiazide in reducing stroke and other cardiovascular and cerebrovascular events, and to explore the relationship between various alternative measures and efficacy.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-01
• Primary Completion: 2019-07-31
• Study Completion: 2020-07-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-20
• Study First Submitted QC: 2021-06-27
• Study First Posted: 2021-07-07
• Last Update Submitted: 2021-07-18
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• 1.40-75 years old (inclusive);
• 2. Patients who have been diagnosed with all types of essential hypertension (those who are currently taking antihypertensive drugs with normal blood pressure can still be admitted) or those whose blood pressure screening meets the inclusion criteria;
• 3. Plasma (or serum) Hcy 10 mol/L;
• 4. Enalapril folic acid tablet 10.8 mg/day alone is not up to standard;
• 5. In the case of women of reproductive age, agree to use a reliable method of contraception during the trial;
• 6. Participate voluntarily and sign the informed consent;

Exclusion Criteria

• 1. Previous stroke with definite diagnosis;
• 2. Patients with previous well-diagnosed myocardial infarction;
• 3. The presence of well-diagnosed heart failure;
• 4. Postoperative revascularization;
• 5.DBP >=110 mmHg or SBP >=180 mmHg;
• 6. Confirmed secondary hypertension;
• 7. Severe physical and systemic disease, which is estimated to be unable to complete the follow-up;
• 8. People with known congenital or acquired organic heart disease;
• 9. People who have had obvious intolerable adverse reactions to ACEI drugs in the past;
• 10. Have contraindications to ACEI drugs (including renal failure) or are allergic to the drugs used in the study or other ingredients in the drugs;
• 11. According to the researchers, there are contraindications to the use of folic acid;
• 12. Pregnant and lactating women;
• 13. If there are other obvious laboratory tests, abnormal physical signs and clinical diseases, it is not suitable to participate in the study according to the researcher's judgment;
• 14. Unwilling to participate in the trial, unwilling or unable to change the existing medication regimen;
• 15. Long-term use of folic acid or health medicines containing folic acid;
• 16.Severe mental disorder, unable to express their will

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enalapril Folic Acid Tablets Combined With amlodipine	Enalapril Folic Acid Tablets Combined With amlodipine	Enalapril Folic Acid Tablets 10.8mg Combined With amlodipine 5 or 10mg
Enalapril Folic Acid Tablets Combined With hydrochlorothiazide	Enalapril Folic Acid Tablets Combined With hydrochlorothiazide	Enalapril Folic Acid Tablets 10.8mg Combined With hydrochlorothiazide 12.5 or 25mg

Primary Outcome Measures

Name	Time	Method
Stroke rate	Until 5 years

Secondary Outcome Measures

Name	Time	Method
Rate of combined end points of cardiovascular events	Until 5 years	Including cardiogenic death, cerebrovascular death, non-fatal stroke, and myocardial infarction
Rate of all causes of death	Until 5 years	Including all causes and unexplained deaths
Rate of first or recurrent ischemic stroke	Until 5 years
Rate of first or recurrent hemorrhagic stroke	Until 5 years
Rate of myocardial infarction	Until 5 years

Trial Locations

Locations (1)

Second affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China