Single triple-combination blood pressure pill after intracerebral hemorrhage
TRIple Antihypertensive Medication After Intracerebral Hemorrhage for Blood Pressure ConTrol With the TRICH Score
This trial tests whether a single pill combining amlodipine, valsartan, and hydrochlorothiazide helps adults who recently had an intracerebral hemorrhage control their blood pressure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 4 sites (Hong Kong, Hong Kong and 3 other locations) |
| Trial ID | NCT07458880 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares a fixed-dose triple-combination antihypertensive pill (Exforge HCT®) to the same three drugs given individually in adults soon after spontaneous intracerebral hemorrhage. Eligible patients are adults with recent ICH (within one week), premorbid function mRS ≤3 and TRICH score ≥3, who can perform home blood-pressure monitoring and follow-up. Patients with very low admission SBP, severe renal impairment, severe decreased consciousness, or contraindications to any component are excluded. The main approach is practical: improve adherence and BP control using a single-pill regimen to reduce recurrent ICH and cardiovascular events.
Who should consider this trial
Good fit: Adults (≥18) who had a spontaneous intracerebral hemorrhage within the past week, with premorbid mRS ≤3, TRICH score ≥3, and ability to perform home blood-pressure monitoring and follow-up activities are ideal candidates.
Not a fit: Patients with admission SBP <160 mmHg, Glasgow Coma Score <9, severe renal impairment (eGFR <30), known hypersensitivity or contraindication to amlodipine, valsartan, or hydrochlorothiazide, or inability to monitor BP at home are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, this approach could improve blood pressure control and adherence with a simpler single-pill regimen, potentially lowering the risk of recurrent ICH and other cardiovascular events.
How similar studies have performed: Combination antihypertensive therapy and aggressive BP lowering after ICH have supportive evidence for reducing recurrence, but using a single fixed triple-combination pill specifically in recent ICH survivors is relatively novel and not yet widely proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Spontaneous ICH 2. Age ≥18 years 3. Premorbid modified Rankin Scale of ≤3 4. TRICH score ≥3 5. Within 1 week of ICH Exclusion Criteria: 1. Glasgow coma score \<9 2. Expected life expectancy of six months 3. Admission SBP \<160mmHg 4. Severe renal impairment, estimated glomerular filtration rate using CKD-EPI formula \<30 ml/min/1.73m2 5. Inability to perform home BP monitoring 6. Inability to participate in follow-up activity 7. Hypersensitivity to study drug 8. Known contraindication to amlodipine 9. Known contraindication to valsartan 10. Known contraindication to hydrochlorothiazide 11. Any conditions that investigator deems that patient is not suitable of any component of the triple pill or antihypertensive medications in general
Where this trial is running
Hong Kong, Hong Kong and 3 other locations
- Princess Margaret Hospital — Hong Kong, Hong Kong, Hong Kong (Not_yet_recruiting)
- Queen Mary Hospital — Hong Kong, Hong Kong, Hong Kong (Recruiting)
- Ruttonjee Hospital — Hong Kong, Hong Kong, Hong Kong (Not_yet_recruiting)
- Yan Chai Hospital — Hong Kong, Hong Kong, Hong Kong (Not_yet_recruiting)
Study contacts
- Study coordinator: Kay Cheong TEO
- Email: kcteo@hku.hk
- Phone: +852 2255 5318
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.