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

Primary Purpose

Hypertension

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Enalapril Folic Acid Tablets Combined With amlodipine

Enalapril Folic Acid Tablets Combined With hydrochlorothiazide

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Second affiliated Hospital Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enalapril Folic Acid Tablets Combined With amlodipine

Enalapril Folic Acid Tablets Combined With hydrochlorothiazide

Arm Description

Enalapril Folic Acid Tablets 10.8mg Combined With amlodipine 5 or 10mg

Enalapril Folic Acid Tablets 10.8mg Combined With hydrochlorothiazide 12.5 or 25mg

Outcomes

Primary Outcome Measures

Stroke rate

Secondary Outcome Measures

Rate of combined end points of cardiovascular events

Including cardiogenic death, cerebrovascular death, non-fatal stroke, and myocardial infarction

Rate of all causes of death

Including all causes and unexplained deaths

Rate of first or recurrent ischemic stroke

Rate of first or recurrent hemorrhagic stroke

Rate of myocardial infarction

Full Information

NCT ID

NCT04952051

First Posted

June 20, 2021

Last Updated

July 18, 2021

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

National Clinical Research Center, Southern Medical University, Ningbo Yinzhou Community Health Service Center

1. Study Identification

Unique Protocol Identification Number

NCT04952051

Brief Title

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

Official Title

Randomized Controlled Blind End Point Study of Enalapril Folic Acid Tablets Combined With Calcium Antagonist or Diuretic to Prevent Stroke in Patients With Type H Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

July 1, 2014 (Actual)

Primary Completion Date

July 31, 2019 (Actual)

Study Completion Date

July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

National Clinical Research Center, Southern Medical University, Ningbo Yinzhou Community Health Service Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Enalapril Folic Acid Tablets Combined With amlodipine

Arm Type

Experimental

Arm Description

Enalapril Folic Acid Tablets 10.8mg Combined With amlodipine 5 or 10mg

Arm Title

Enalapril Folic Acid Tablets Combined With hydrochlorothiazide

Arm Type

Active Comparator

Arm Description

Enalapril Folic Acid Tablets 10.8mg Combined With hydrochlorothiazide 12.5 or 25mg

Intervention Type

Drug

Intervention Name(s)

Enalapril Folic Acid Tablets Combined With amlodipine

Intervention Description

Enalapril Folic Acid Tablets 10.8mg Combined With amlodipine 5 or 10mg

Intervention Type

Drug

Intervention Name(s)

Enalapril Folic Acid Tablets Combined With hydrochlorothiazide

Intervention Description

Enalapril Folic Acid Tablets 10.8mg Combined With hydrochlorothiazide 12.5 or 25mg

Primary Outcome Measure Information:

Title

Stroke rate

Time Frame

Until 5 years

Secondary Outcome Measure Information:

Title

Rate of combined end points of cardiovascular events

Description

Including cardiogenic death, cerebrovascular death, non-fatal stroke, and myocardial infarction

Time Frame

Until 5 years

Title

Rate of all causes of death

Description

Including all causes and unexplained deaths

Time Frame

Until 5 years

Title

Rate of first or recurrent ischemic stroke

Time Frame

Until 5 years

Title

Rate of first or recurrent hemorrhagic stroke

Time Frame

Until 5 years

Title

Rate of myocardial infarction

Time Frame

Until 5 years

Other Pre-specified Outcome Measures:

Title

Rate of heart failure (hospitalization)

Time Frame

Until 5 years

Title

Rate of coronary revascularization

Time Frame

Until 5 years

Title

Rate of peripheral arterial revascularization

Time Frame

Until 5 years

Title

Rate of malignant tumor

Time Frame

Until 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jian-an Wang

Organizational Affiliation

Second Affiliated Hospital of Zhejiang University, School of Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Second affiliated Hospital Zhejiang University School of Medicine

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

12. IPD Sharing Statement

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

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