Anderson, Craig S; Rodgers, Anthony; de Silva, H Asita; Martins, Sheila Ouriques; Klijn, Catharina Jm; Senanayake, Bimsara; Freed, Ruth; Billot, Laurent; Arima, Hisatomi; Thang, Nguyen Huy; Zaidi, Wan Asyraf Wan; Kherkheulidze, Tinatin; Wahab, Kolawole; Fischer, Urs; Lee, Tsong-Hai; Chen, Christopher; Pontes-Neto, Octavio; Robinson, Thompson; Wang, Jiguang; Naismith, Sharon; ... (2022). Triple Therapy Prevention of Recurrent Intracerebral Disease Events Trial: Rationale, design and progress. International journal of stroke, 17(10), pp. 1156-1162. SAGE 10.1177/17474930211068671
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BACKGROUND
Patients who suffer intracerebral hemorrhage (ICH) are at very high risk of recurrent ICH and other serious cardiovascular events. A single-pill combination (SPC) of blood pressure (BP) lowering drugs offers a potentially powerful but simple strategy to optimize secondary prevention.
OBJECTIVES
The Triple Therapy Prevention of Recurrent Intracerebral Disease Events Trial (TRIDENT) aims to determine the effects of a novel SPC "Triple Pill," three generic antihypertensive drugs with demonstrated efficacy and complementary mechanisms of action at half standard dose (telmisartan 20 mg, amlodipine 2.5 mg, and indapamide 1.25 mg), with placebo for the prevention of recurrent stroke, cardiovascular events, and cognitive impairment after ICH.
DESIGN
An international, double-blind, placebo-controlled, randomized trial in adults with ICH and mild-moderate hypertension (systolic BP: 130-160 mmHg), who are not taking any Triple Pill component drug at greater than half-dose. A total of 1500 randomized patients provide 90% power to detect a hazard ratio of 0.5, over an average follow-up of 3 years, according to a total primary event rate (any stroke) of 12% in the control arm and other assumptions. Secondary outcomes include recurrent ICH, cardiovascular events, and safety.
RESULTS
Recruitment started 28 September 2017. Up to 31 October 2021, 821 patients were randomized at 54 active sites in 10 countries. Triple Pill adherence after 30 months is 86%. The required sample size should be achieved by 2024.
CONCLUSION
Low-dose Triple Pill BP lowering could improve long-term outcome from ICH.
Item Type: |
Journal Article (Original Article) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology |
UniBE Contributor: |
Fischer, Urs Martin |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
1747-4949 |
Publisher: |
SAGE |
Language: |
English |
Submitter: |
Chantal Kottler |
Date Deposited: |
07 Nov 2022 15:21 |
Last Modified: |
05 Dec 2022 16:27 |
Publisher DOI: |
10.1177/17474930211068671 |
PubMed ID: |
34994269 |
Uncontrolled Keywords: |
Hypertension blood pressure lowering clinical trial intracerebral hemorrhage outcomes |
BORIS DOI: |
10.48350/174564 |
URI: |
https://boris.unibe.ch/id/eprint/174564 |
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