In patients with non-
cardio-embolic stroke,
atorvastatin 80 mg/day reduced the relative risk of recurrent
stroke by 16%, and a post hoc analysis showed that achieving an
LDL-c of less than 70 mg/dL reduced the relative risk by 28% as compared to an on-treatment
LDL of 100 mg/dL or more. Current guidelines from the French drug agency recommend treating with a
statin after an
ischaemic stroke to a target of less than 100 mg/dL, but no study directly tested
LDL-c targets. The Treat
Stroke to Target (TST) trial will compare the efficacy of achieving an
LDL-c of less than 70 mg/dL versus an achieved
LDL-c of 100 ± 10 mg/dL for
secondary prevention in patients with recent
ischaemic stroke of atherosclerotic origin.Main hypothesis: An achieved on-treatment
LDL-c of less than 70 mg/dL will reduce by 25% the risk of recurrent
ischaemic stroke,
myocardial infarction, urgent coronary or carotid revascularisation following new symptoms requiring hospitalisation, and vascular death compared with on-treatment
LDL-c of 100 ± 10 mg/dL.
DESIGN: Patients are randomised to either
LDL-c levels, and the investigator who is not blinded can use the
lipid-lowering agent of his/her choice available on the market (including
statins and
ezetimibe), in order to achieve the assigned
LDL-c level. To be eligible for enrolment, patients have a recent
ischaemic stroke or TIA of atherosclerotic origin with at least one arterial
stenosis of a cerebral artery, enrolled between acute phase of the qualifying
stroke (once the neurological deficit is stabilised) and three months. The initial planned sample size of 3760 participants followed three years was amended to allow follow-up of all enrolled patients until 385 primary efficacy outcome events have occurred, and no later than 31 December 2019. Patients will be recruited in 76 sites in two countries (France and South Korea) between March 2010 and December 2018 (last included patient followed up to one year). Safety outcomes will include haemorrhagic
strokes and new onset diabetes. All primary endpoints will be adjudicated by an endpoint committee, blinded to the assigned
LDL-c level. Two sub-studies assess (1) the relative effect of assigned
LDL-c levels on occurrence of new
atherosclerotic plaque as detected by carotid ultrasound during follow-up, using M'ATH software for repositioning and (2) the genetic and
biomarker drivers of recurrent primary endpoints according to assigned
LDL-c lowering arm, in atherosclerotic
strokes.
SUMMARY: The TST trial is evaluating the benefits of achieving an
LDL-c less than 70 mg/dL for secondary
stroke prevention in
ischaemic stroke patients of atherosclerotic origin. Main results are anticipated in 2020 or earlier (ClinicalTrials.gov NCT01252875).