China Stroke Primary Prevention Trial for Subjects With H-type Hypertension and MTHFR 677 CC/CT Genotype
Status:
Not yet recruiting
Trial end date:
2026-07-31
Target enrollment:
Participant gender:
Summary
This is a multicenter, randomized, controlled, clinical trial stratified by participants with
the MTHFR 677 genotype (CC and CT) in a 1:1 ratio. It aims to investigate the treatment
effects of amlodipine folic acid vs. amlodipine on reducing the risk of first ischemic stroke
among those participants with the MTHFR 677 CC/CT genotype and H-type hypertension
(hypertension with increasing homocysteine (Hcy)).
This study consists of 3 phases: Screening, Run-in period (0 or 2 weeks), and randomized
treatment (5 years), with a prospective, randomized, open-label, blinded end-point design.
Phase:
Phase 4
Details
Lead Sponsor:
Shenzhen Ausa Pharmed Co.,Ltd
Collaborators:
First Affiliated Hospital of Harbin Medical University Peking University First Hospital Second Affiliated Hospital of Nanchang University Shenzhen CCHRPP Biomedical Institute The First Affiliated Hospital of Shanxi Medical University The First People's Hospital of Lianyungang