TRIDENT
Research type
Research Study
Full title
Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT)
IRAS ID
230938
Contact name
Rustam Al-Shahi Salman
Contact email
Sponsor organisation
The George Institute for Global Health, University of New South Wales
Eudract number
2016-003724-23
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
12616000327482, ANZCTR
Duration of Study in the UK
4 years, 10 months, 7 days
Research summary
Intracerebral haemorrhage (ICH) is the most serious and least treatable form of stroke. It affects at least 1 in 10 out of the 20 million new strokes that occur in the world each year. Survivors of ICH are at risk of another stroke. Blood pressure (BP) lowering is an important method to prevent another stroke but - despite strong evidence in support of BP lowering - data show that BP is poorly controlled in these patients. TRIDENT will investigate whether an approach that uses a 'Triple Pill' strategy (a single capsule containing three low dose BP-lowering drugs) in ICH patients with mild to moderate hypertension can reduce the risk of recurrent stroke when compared with placebo medication in adults (≥18 years) with a history of CT-confirmed primary ICH of up to 6 months after the onset of symptoms. 4,200 participants will be randomised in this international trial to either a Triple Pill or Placebo Pill for 36 months follow-up after a 14 day active run-in phase in which all potential participants will receive the Triple Pill.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
17/ES/0122
Date of REC Opinion
20 Oct 2017
REC opinion
Further Information Favourable Opinion