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Clinical Trials List

Protocol NumberGI-AU-NMH-2016-01

2017-11-01 - 2021-12-08

Phase III

Recruiting3

Study ended1

ICD-10I61

Nontraumatic intracerebral hemorrhage

ICD-9431

Intracerebral hemorrhage

Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT)

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 劉嘉為 Division of Neurology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 李建德 Division of Neurology
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsong-Hai Lee Division of Neurology
Linkou Chang Gung Medical Foundation

Taiwan National PI

李宗海

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

22 Recruiting

Audit

None

Principal Investigator A-Ching Chao Division of Neurology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Study ended

Condition/Disease

Acute primary cerebral hemorrhage

Objectives

Trial to determine the effect of more intensive BP control provided by a fixed low-dose BP lowering combination pill (“Triple Pill”) strategy, on top of standard of care, for the prevention of recurrent stroke in patients with a history of acute spontaneous intracerebral haemorrhage.

Test Drug

Three-dose combination(telmisartan, amlodipine, indapamide)

Active Ingredient

Amlodipine
Indapamide
Telmisartan

Dosage Form

cap
cap
cap

Dosage

20mg
2.5mg
1.25mg

Endpoints

Primary Outcome
Time to 1st recurrent stroke whether ischaemic or haemorrhagic

Secondary Outcomes
Recurrent ICH, ischaemic stroke, fatal or disabling stroke, mortality
MACE – CV death, non-fatal myocardial infarction, or non-fatal stroke)
Health-related quality of life (EQ-5D-3L)
Physical function (smRS)
Cognitive impairment (MoCA, BMET)
Medication Adherence
Self-report and pill counts

Inclution Criteria

Adult (≥ 20 years)
History of primary ICH confirmed by imaging, up to 6 months after symptom onset
Clinically stable, as decided by investigator
Two resting SBP levels, measured 5 mins apart in the range 130-160mmHg, recorded in a seated position
Geographical proximity to recruiting hospital for follow-up clinic visits
No clear contraindication to any of the study treatments
Provision of written informed consent

Exclusion Criteria

Taking an ACE-I that cannot be changed to:
Telmisartan 20 or 40mg, amlodipine 2.5 or 5 mg indapamide 1.25 or 2.5 mg
an equivalent class (ARB, CCB or thiazide-like diuretic) or a beta blocker
Contraindication to any of the study medications, with their existing BP lowering medication
Unable to complete study procedures and/or follow-up
Females of child-bearing age and capability, who are pregnant or breast-feeding, or those not using adequate birth control
Significant hyperkalaemia and/or hyponatremia, in the opinion of the responsible physician
Estimated glomerular filtration rate (eGFR) <30 mL/min
Severe hepatic impairment (ALT or AST >3x the ULN)
Any other condition that in the opinion of the responsible physician investigator renders the patient unsuitable for the study (e.g. severe disability [i.e. smRS of 4-5] or significant memory or behavioural disorder)

The Estimated Number of Participants

  • Taiwan

    400 participants

  • Global

    1875 participants

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