China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype (NCT04974151) | Clinical Trial Compass
RecruitingPhase 4
China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype
China24,000 participantsStarted 2024-08-22
Plain-language 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.
Who can participate
Age range45 Years – 74 Years
SexALL
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Inclusion criteria
✓. Men and women, aged ≥45 and \<75 years.
✓. Hypertension: Previously diagnosed with primary hypertension and has been taking antihypertensive medication within the past two weeks; OR has not been taking antihypertensive medications within the last two weeks, but meets the following criteria for hypertension: SBP≥140 mmHg and/or DBP≥90 mmHg (average of at least 2 measurements each time) at two separate (not on the same day) clinical visits.
✓. MTHFR 677 TT genotype (based on the test results from the central laboratory during the screening period or a previous official test report from a laboratory with medical testing qualifications).
✓. Voluntarily participates and has given signed informed consent.
✓. Good compliance during the run-in period, and unlikely to discontinue treatment;
✓. No stroke or cardiovascular events during the run-in period;
✓. The participant voluntarily agrees to continue the study.
Exclusion criteria
✕. Previously diagnosed secondary hypertension;
What they're measuring
1
First ischemic stroke
Timeframe: By the end of the fifth year of the study