China Stroke Primary Prevention Trial 2 for Participants With H-type Hypertension and MTHFR 677 CC/CT Genotype (CSPPT2-CC/CT)

Summary

This is a multi-center, randomized, double-blind, double-dummy, controlled clinical trial. This trial will include 32,000 Chinese men and women with hypertension (H-type hypertension), MTHFR 677 CC or CT genotype, elevated plasma total homocysteine (tHcy ≥10µmol/L), and insufficient serum folate levels (\<12ng/mL).

The participants will be first stratified by their MTHFR 677 genotype (CC vs. CT), then randomized to one of two treatment groups in a 1:1 ratio.

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.

The treatment period is five years and primary endpoint is first ischemic stroke.

Conditions

• Hypertension
• MTHFR 677 CC or CT Genotype
• Elevated Plasma Homocysteine (Hcy≥10µmol/L)
• Insufficient Plasma Folate Levels (<12ng/mL)

Interventions

DRUG

Amlodipine besylate

The amlodipine used in this study is a listed product. Amlodipine tablets and amlodipine folic acid (dummy) are provided in aluminum-plastic blisters packaging. Each package includes 100 days of treatment drug (including 10 extra days of treatment for the follow-up window). A package of medication consists of 20 plates, each plate includes a total of 10 tablets arranged as follows: amlodipine 5mg/tablet x5 tablets + amlodipine-folic acid (dummy) x5 tablets. Affixed to the medication package is the randomized treatment drug label (200 tablets/package, 2 tablets/day).

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. Amlodipine-folic acid tablets and amlodipine (dummy) are provided in aluminum-plastic blisters packaging. Each package includes 100 days of treatment drug (including 10 extra days of treatment for the follow-up window). A package of medication consists of 20 plates, each plate includes a total of 10 tablets arranged as follows: amlodipine-folic acid 5.8mg x5 tablets + amlodipine (dummy) x5 tablets. Affixed to the medication package is the randomized treatment drug label (200 tablets/package, 2 tablets/day).

DRUG

Amlodipine placebos

An amlodipine placebo is a dummy pill of an amlodipine tablet with an identical appearance.

DRUG

Amlodipine-folic acid placebos

An Amlodipine folic acid placebo is a dummy pill of an amlodipine folic acid tablet with an 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

• Lianyungang Second People's Hospital

  collaborator UNKNOWN

• The Affiliated Hospital Of Southwest Medical University

  collaborator OTHER

• Chengdu Fifth People's Hospital

  collaborator OTHER

• Chizhou people's hospital

  collaborator UNKNOWN

• Shenzhen Ausa Pharmed Co.,Ltd

  lead INDUSTRY

Principal Investigators

• Yong Huo, 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

2030-06-30

Completion

2030-06-30

Countries

• China

Study Locations