China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype

Summary

This is a multi-center, randomized, double-blind, triple-dummy, controlled trial in 24,000 Chinese men and women with hypertension and MTHFR 677 TT genotype.

The study participants will be randomized to one of the three treatment groups:

Group A: amlodipine tablet (5mg), taken orally, once daily, serving as active comparator.

Group B: amlodipine folic acid 5.8mg tablet (5mg amlodipine and 0.8mg folic acid), taken orally, once daily.

Group C: amlodipine folic acid 5.8mg tablet plus 5-methyltetrahydrofolate (5-MTHF, 0.4mg), taken orally, once daily.

The primary endpoint is first ischemic stroke.

Conditions

• Hypertension
• MTHFR 677 TT Genotype

Interventions

DRUG

Amlodipine besylate

The amlodipine used in this study is a listed product.

DRUG

Amlodipine besylate And Folic Acid

The amlodipine besylate and folic acid tablets have been approved for listing by the China Food and Drug Administration, approval number: Zhunzi H20180020.

DRUG

5-methyltetrahydrofolate (5-MTHF)

The 5-MTHF used in this study is a listed product.

DRUG

Amlodipine placebo

Amlodipine placebos are dummy pills of amlodipine with identical appearance.

DRUG

Amlodipine folic acid placebo

Amlodipine folic acid placebos are dummy pills of amlodipine folic acid with identical appearance.

DRUG

5-MTHF Placebos

5-MTHF placebos are the dummy pills of 5-MTHF with identical appearance.

Sponsors & Collaborators

• Peking University First Hospital

  collaborator OTHER

• Second Affiliated Hospital of Nanchang University

  collaborator OTHER

• The First People's Hospital of Lianyungang

  collaborator OTHER

• The Affiliated Hospital Of Guizhou Medical University

  collaborator OTHER

• Lianyungang Oriental Hospital

  collaborator OTHER

• Tengzhou Central People's Hospital

  collaborator OTHER_GOV

• The First Affiliated Hospital of Bengbu Medical University

  collaborator OTHER

• Shenzhen Prospective Medical Technology Co., LTD

  collaborator UNKNOWN

• Weinan Central Hospital

  collaborator OTHER

• The First Affiliated Hospital of HuNan University of Medicine

  collaborator UNKNOWN

• Loudi Central Hospital

  collaborator OTHER

• Yancheng First People's Hospital

  collaborator OTHER

• TAIHE country people's hospital

  collaborator UNKNOWN

• First Affiliated Hospital of Gannan Medical University

  collaborator OTHER

• Yangjiang People's Hospital

  collaborator OTHER

• Deyang People's Hospital

  collaborator OTHER

• Bozhou people's hospital

  collaborator UNKNOWN

• Chizhou people's hospital

  collaborator UNKNOWN

• Lianyungang Second People's Hospital

  collaborator UNKNOWN

• The Affiliated Hospital Of Southwest Medical University

  collaborator OTHER

• Chengdu Fifth People's Hospital

  collaborator OTHER

• Shenzhen Ausa Pharmed Co.,Ltd

  lead INDUSTRY

Principal Investigators

• Jianping Li, MD, PhD · Peking University First Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-22

Primary Completion

2029-06-30

Completion

2029-06-30

Countries

• China

Study Locations