A Multicenter, Randomized, Double-blind, Placebo-controlled Trial on the Treatment of Hypertensiv… (NCT07200921) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial on the Treatment of Hypertensive Intracerebral Hemorrhage With Naoxuekang Dropping Pills
China1,950 participantsStarted 2025-10-10
Plain-language summary
This study aims to evaluate the effectiveness and safety of a Chinese medicine-based intervention combined with standard medicine, in reducing composite vascular events in patients with hypertensive intracerebral hemorrhage (HICH).This is a multicenter, randomized, double-blind, placebo-controlled trial. A total of 1950 participants with HICH within 7 days of onset, accompanied by imaging evidence of cerebral small vessel disease, will be enrolled.Participants will be randomly assigned to receive eitherNaoxuekang Dropping Pills or matching placebo for 90 days, in addition to guideline-based standard care.The primary outcome is the incidence of composite vascular events (including ischemic stroke, hemorrhagic stroke, myocardial infarction, vascular death, deep vein thrombosis, and pulmonary embolism) within 1 year.Secondary outcomes include vascular events within 90 days, neurological function (mRS), and cognitive function (MMSE, MoCA) at 90 days and 1 year.Safety will be monitored through adverse event reporting.The results will provide evidence for optimizing secondary prevention strategies in HICH patients.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Meets the diagnostic criteria for hypertensive intracerebral hemorrhage.
. Able to cooperate with a head MRI examination and has imaging manifestations of cerebral small vessel disease (CSVD) (Staals total CSVD burden score ≥ 1).
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Composite Vascular Events
Timeframe: Within 1 year after the onset of intracerebral hemorrhage.
. Spontaneous intracerebral hemorrhage due to other causes or secondary intracerebral hemorrhage (e.g., from trauma, vascular malformations, coagulation disorders, hematological diseases, systemic diseases, or tumors).
. Planned surgical intervention (including craniotomy for hematoma evacuation, minimally invasive hematoma removal, or ventricular puncture).
. Patients with active peptic ulcer, bleeding, or other clear tendency for rebleeding.
. Patients with severe hepatic or renal dysfunction (Severe hepatic dysfunction: ALT or AST \> 3 times the upper limit of normal; Severe renal dysfunction: Serum creatinine \> 2 times the upper limit of normal).
. Suffering from other life-threatening severe diseases with an expected survival time of less than 1 year.
. Known allergy to any component of the study drug.
. Pregnant women, women planning pregnancy, or lactating women.