Ischemic StrokeTSTNCT01252875
Treat Stroke to Target
A study testing Target : 100 mg/dL (+/-10 mg/dL) and 70 mg/dL in people with Ischemic Stroke and Transient Ischemic Attack, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
The aim of this study is the evaluation of two usual care strategies after stroke or TIA : achieved target LDL-C of 100 mg/dL (+/-10 mg/dL) or less than 70 mg/dL. Investigators will use the statin and titrate the dosage to achieve the target assigned by randomization in monotherapy or in combination with ezetimibe or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Transient Ischemic Attack, Atherosclerotic Stenosis
- What is being tested?
- Target : 100 mg/dL (+/-10 mg/dL) and 70 mg/dL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,873 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Mar 2010to 26 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Recent (less than 3 months) ischemic stroke
- As soon as possible after the event, once the neurologic deficit is stabilized (investigator judgment)
- These ischemic strokes include TIA with ischemic lesion documented by CT or MRI
- Or recent TIA (less than 15 days)
- without documentation of ischemic lesion on CT/MR imaging
- Must be limb weakness or aphasia lasting more than 10 min
Show all 17Show fewer
- And documented atherosclerotic stenosis
- In carotid artery (investigator judgment) (based on the results of Duplex echography, CTA, MRA or X ray- angiography)
- Or in the aortic arch (investigator judgment) (based on TEE or CTA)
- Or in other brain artery: vertebral, basilar or other intracranial artery (based on CTA, MRA, XRA)
- Or in coronary arteries (past history of acute coronary syndrome, coronary revascularization or positive coronary angiography)
- And
- Statin treatment is indicated, following ANSM guidelines (French drug agency)
- age >18 years
- rankin score ≤ 4
- patient or a legal representative signs consent
- Patient is affiliated to social security system
Who cannot join
- • Ischemic stroke/TIA du to
- arterial dissection (investigator judgment)
- Cardiac source of embolism (e.g., mitral stenosis, endomyocardial fibrosis) without documented atherosclerotic stenosis : a patient with atrial fibrillation or a past history of recent myocardial infarction or calcified aortic stenosis can be randomized if he otherwise fulfils inclusion criteria
- Symptomatic hemorrhagic stroke
- Presence of microbleeds on gradient echo imaging (T2*) is not an exclusion criteria.
- Hemorrhagic transformation of an ischemic stroke is not an exclusion criteria
Show all 11Show fewer
- Uncontrolled hypertension (investigator judgment)
- LDL-C <100 mg/dL or patients for whom treatment intensification is impossible
- F/U impossible or bad observance anticipated.
- Co-morbid condition that may interfere with the F/U or with the evaluation of primary endpoint
- Participation to another clinical trial
Trial locations and contacts
2 sites in 1 country.
France2 sites
BICHAT HOSPITAL Departement of Neurology
Paris, 75018
BICHAT HOSPITAL Department of neurology and stroke center
Paris, 75018
About this study
Official title: EVALUATION OF TWO SECONDARY CARE STRATEGIES AFTER STROKE OR TRANSIENT ISCHEMIC ATTACK (TIA): ACHEIVED TARGET LDL-C TO 100 mg/dL (+/- 10,mg/dL) OR LESS THAN 70 mg/dL.
The aim of this study is the evaluation of two usual care strategies after stroke or TIA : achieved target LDL-C of 100 mg/dL (+/-10 mg/dL) or less than 70 mg/dL. Investigators will use the statin and titrate the dosage to achieve the target assigned by randomization in monotherapy or in combination with ezetimibe or other drugs.
The primary end-point is the occurrence of recurrent non fatal stroke, non fatal MI, and vascular death in each group.
3760 patients will be recruited and followed for eight and a half years maximum.
Read the detailed description
The aim of this study is the evaluation of two usual care strategies after stroke or TIA : achieved target LDL-C of 100 mg/dL (+/-10 mg/dL) or less than 70 mg/dL. Investigators will use the statin and titrate the dosage to achieve the target assigned by randomization in monotherapy or in combination with ezetimibe or other drugs.
Inclusion criteria:
- Recent (less than 3 months) ischemic stroke As soon as possible after the event, once the neurologic deficit is stabilized (investigator judgment). These ischemic strokes include TIA with ischemic lesion documented by CT or MRI.
- Or recent TIA (less than 15 days) without documentation of ischemic lesion on CT/MR imaging. Must be limb weakness or aphasia lasting more than 10 min.
- And documented atherosclerotic stenosis in carotid artery (investigator judgment) (based on the results of Duplex echography, CTA, MRA or X ray- angiography), Or in the aortic arch (investigator judgment) (based on TEE or CTA), Or in other brain artery: vertebral, basilar or other intracranial artery (based on CTA, MRA, XRA), Or in coronary arteries (past history of acute coronary syndrome, coronary revascularization or positive coronary angiography)
- And statin treatment is indicated, following ANSM guidelines (French drug agency), age >18 years, rankin score ≤ 4, patient or a legal representative signs consent, patient is affiliated to social security system
Exclusion criteria :
- Ischemic stroke/TIA du to arterial dissection (investigator judgment)
- Cardiac source of embolism (e.g., mitral stenosis, endomyocardial fibrosis) without documented atherosclerotic stenosis : a patient with atrial fibrillation or a past history of recent myocardial infarction or calcified aortic stenosis can be randomized if he otherwise fulfils inclusion criteria
- Symptomatic hemorrhagic stroke : Presence of microbleeds on gradient echo imaging (T2*) is not an exclusion criteria. Hemorrhagic transformation of an ischemic stroke is not an exclusion criteria
- Uncontrolled hypertension (investigator judgment)
- LDL-C <100 mg/dL or patients for whom treatment intensification is impossible
- F/U impossible or bad observance anticipated.
- Co-morbid condition that may interfere with the F/U or with the evaluation of primary endpoint
- Participation to another clinical trial
The primary end-point is:
Recurrent ischemic stroke or stroke of undetermined origin, myocardial infarction, urgent coronary or carotid revascularization following new symptoms requiring hospitalization, and vascular death.
Secondary endpoints:
- Recurrent nonfatal ischemic stroke
- Nonfatal myocardial infarction
- Recurrent ischemic stroke, fatal or non
- Recurrent ischemic stroke or TIA
- Intracranial hemorrhage (intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma)
- All stroke (ischemic or hemorrhagic)
- Any major coronary events (including fatal and nonfatal myocardial infarction)
- Any coronary heart disease end-point (myocardial infarction, hospitalization for acute corornary symptoms, coronary revascularization procedure)
- Any revascularisation procedure (coronary, carotid, or peripheral artery))
- Carotid artery revascularization procedure (urgent following new symptoms or elective)
- Vascular death (ischemic stroke or undetermined stroke, fatal myocardial infarction, other vascular deaths, sudden death, death of undetermined cause, i.e., without other cause documented such as cancer, infection, accident, suicide, etc…)
- All causes deaths
- Primary endpoint plus intracranial hemorrhage
- New onset diabetes
Hypothesis :
- Follow-up of three years
- Risk of primary end-point in the control group (Target LDL <100 mg/dL) : 4% per year (12 % at 36 months)
- 5% Alpha, 80% power, total number of subject is :
- 3068 patients with a RRR 25%
- 20% drop-out: 3760 patients (385 primary EP)
Study specifications Follow-up : eight and a half years Follow-up visit : every 6 months Number of centers (French Stroke Units, under the auspice of the French Neurovascular Society) : 60-100
Ancillary study As an ancillary study, 800 patients (400 in each arm in 4 centers) will participate in the TST-PLUS (Plaque Ultrasound Study), in which they will have three ultrasound examination (baseline, 1 year and 3 years) and baseline blood sampling. The primary endpoint of this substudy will be the rate of occurrence of new carotid plaque, with the hypothesis that Rate of plaque occurrence in the <100 mg/dL group will be 25% after 3 years (45% in EVA when atherosclerosis was present at baseline) RRR of plaque of 25% in the <70 mg/dL group Alpha 5%, power 80%
As an ancillary study, 1000 patients will participate in the TST-PGS (Pharmacogenetics) Study, in which they will have 1 blood sampling either at baseline or during one of the follow-up visits of TST. The aim of this study is to show that the benefit (risk of ischemic stroke, myocardial infarction, and vascular death) observed with a strategy of LDL-C <0.7 g / l compared to a strategy of LDL-C to 1 ± 0.1 g / l is higher in carriers of polymorphism 719Arg of the gene KIF-6 than non-carriers of this polymorphism.
- Being tested
- Target : 100 mg/dL (+/-10 mg/dL), 70 mg/dL
- Keywords
- LDL-C, Cholesterol, Stroke, Transient ischemic attack, Statin, Lipid lowering therapy
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target : 100 mg/dL (+/-10 mg/dL)Procedure or surgery
Also called treat to target
Statin +/- other lipid lowering therapy during 3 years, Target : LDL-C =100 mg/dL (+/-10 mg/dL), recording recurrent non fatal stroke, non fatal MI, and vascular death and others endpoints such as new onset diabetes, hemorrhagic strokes.
70 mg/dLProcedure or surgery
Also called treat to target
Statin +/-lipid lowering therapy during eight and a half years maximum, Target : LDL-C concentration of less than 70 mg/dL, recording recurrent of non fatal stroke, non fatal IM, and vascular death and others endpoints such as: new onset diabetes, hemorrhagic strokes.
| Study group | Role | What they receive |
|---|---|---|
| LDL-C to100 mg/dL (+/-10 mg/dL) | Other | Target : 100 mg/dL (+/-10 mg/dL):
Patients recruited in this arm will receive statin +/-other lipid lowering therapy in order to reach a LDL-C concentration of 100 mg/dL(+/-10 mg/dL). Receives: Procedure: Target : 100 mg/dL (+/-10 mg/dL) |
| LDL-C < 70 mg/dL | Other | 70 mg/dL: Patients recruited in this arm will receive statin +/-other lipid lowering therapy in order to reach a LDL-C concentration of less than 70 mg/dL. Receives: Procedure: 70 mg/dL |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrent ischemic stroke or stroke of undetermined origin, myocardial infarction, urgent coronary or carotid revascularization following new symptoms requiring hospitalization, and vascular death.
recurrent ischemic stroke or stroke of undetermined origin, myocardial infarction, urgent coronary or carotid revascularization following new symptoms requiring hospitalization, and vascular death.
Measured: each 6 months
Secondary outcomes (14)
Recurrent nonfatal ischemic stroke
Recurrent nonfatal ischemic stroke
Measured: each 6 months
Nonfatal myocardial infarction
Nonfatal myocardial infarction
Measured: each 6 months
Recurrent ischemic stroke, fatal or non
Recurrent ischemic stroke, fatal or non
Measured: each 6 months
Recurrent ischemic stroke or TIA
Recurrent ischemic stroke or TIA
Measured: each 6 months
Intracranial hemorrhage (intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma)
Intracranial hemorrhage (intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma)
Measured: each three weeks until target is not achieved then each 6 months
All stroke (ischemic or hemorrhagic)
All stroke (ischemic or hemorrhagic)
Measured: each three weeks until target is not achieved then each 6 months
Any major coronary events (including fatal and nonfatal myocardial infarction)
Any major coronary events (including fatal and nonfatal myocardial infarction)
Measured: each 6 months
Any coronary heart disease end-point (myocardial infarction, hospitalization for acute corornary symptoms, coronary revascularization procedure)
Any coronary heart disease end-point (myocardial infarction, hospitalization for acute corornary symptoms, coronary revascularization procedure)
Measured: each 6 months
Any revascularisation procedure (coronary, carotid, or peripheral artery))
Any revascularisation procedure (coronary, carotid, or peripheral artery))
Measured: each 6 months
Carotid artery revascularization procedure (urgent following new symptoms or elective)
Carotid artery revascularization procedure (urgent following new symptoms or elective)
Measured: each 6 months
Vascular death (ischemic stroke or undetermined stroke, fatal myocardial infarction, other vascular deaths, sudden death, death of undetermined cause, i.e., without other cause documented such as cancer, infection, accident, suicide, etc…)
Vascular death (ischemic stroke or undetermined stroke, fatal myocardial infarction, other vascular deaths, sudden death, death of undetermined cause, i.e., without other cause documented such as cancer, infection, accident, suicide, etc…)
Measured: each 6 months
All causes deaths
All causes deaths
Measured: each 6 months
Primary endpoint plus intracranial hemorrhage
Primary endpoint plus intracranial hemorrhage
Measured: each 6 months
New onset diabetes
New onset diabetes
Measured: each 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study start15 Mar 2010
- Primary completion26 May 2019
- Study completion26 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,873 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, AstraZeneca, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Pierre Amarenco, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252875
- Sponsor's protocol ID
- P081244
- Acronym
- TST
- Status last verified
- Jun 2019
- First submitted
- 2 Dec 2010
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Amarenco P, Lavallee PC, Kim JS, Labreuche J, Charles H, Giroud M, Lee BC, Mahagne MH, Meseguer E, Nighoghossian N, Steg PG, Vicaut E, Bruckert E; Treat Stroke to Target Investigators. More Than 50 Percent Reduction in LDL Cholesterol in Patients With Target LDL <70 mg/dL After a Stroke. Stroke. 2023 Aug;54(8):1993-2001. doi: 10.1161/STROKEAHA.123.042621. Epub 2023 Jun 28.
PubMed 37376989Amarenco P, Kim JS, Labreuche J, Charles H, Giroud M, Lee BC, Lavallee PC, Mahagne MH, Meseguer E, Nighoghossian N, Steg PG, Vicaut E, Bruckert E; Treat Stroke to Target Investigators. Yield of Dual Therapy With Statin and Ezetimibe in the Treat Stroke to Target Trial. Stroke. 2022 Nov;53(11):3260-3267. doi: 10.1161/STROKEAHA.122.039728. Epub 2022 Sep 26.
PubMed 36154103Amarenco P, Kim JS, Labreuche J, Charles H, Giroud M, Lavallee PC, Lee BC, Mahagne MH, Meseguer E, Nighoghossian N, Steg PG, Vicaut E, Bruckert E; Treat Stroke to Target Investigators*. Intracranial Hemorrhage in the TST Trial. Stroke. 2022 Feb;53(2):457-462. doi: 10.1161/STROKEAHA.121.035846. Epub 2021 Dec 29.
PubMed 34963300Amarenco P, Kim JS, Labreuche J, Charles H, Giroud M, Lee BC, Lavallee PC, Mahagne MH, Meseguer E, Nighoghossian N, Steg PG, Vicaut E, Bruckert E; Treat Stroke to Target Investigators; Treat Stroke to Target investigators:. Impact of Lower Versus Higher LDL Cholesterol Targets on Cardiovascular Events After Ischemic Stroke in Patients With Diabetes. Diabetes. 2021 Aug;70(8):1807-1815. doi: 10.2337/db21-0302. Epub 2021 May 12.
PubMed 33980690Amarenco P, Hobeanu C, Labreuche J, Charles H, Giroud M, Meseguer E, Lavallee PC, Gabriel Steg P, Vicaut E, Bruckert E, Touboul PJ. Carotid Atherosclerosis Evolution When Targeting a Low-Density Lipoprotein Cholesterol Concentration <70 mg/dL After an Ischemic Stroke of Atherosclerotic Origin. Circulation. 2020 Aug 25;142(8):748-757. doi: 10.1161/CIRCULATIONAHA.120.046774. Epub 2020 Jun 29.
PubMed 32594766Amarenco P, Kim JS, Labreuche J, Charles H, Giroud M, Lee BC, Mahagne MH, Nighoghossian N, Gabriel Steg P, Vicaut E, Bruckert E; Treat Stroke to Target Investigators. Benefit of Targeting a LDL (Low-Density Lipoprotein) Cholesterol <70 mg/dL During 5 Years After Ischemic Stroke. Stroke. 2020 Apr;51(4):1231-1239. doi: 10.1161/STROKEAHA.119.028718. Epub 2020 Feb 20.
PubMed 32078484Amarenco P, Kim JS, Labreuche J, Giroud M, Lee BC, Mahagne MH, Nighoghossian N, Simon T, Steg PG, Touboul PJ, Vicaut E, Yelles N, Bruckert E. Treat stroke to target trial design: First trial comparing two LDL targets in patients with atherothrombotic strokes. Eur Stroke J. 2019 Sep;4(3):271-280. doi: 10.1177/2396987319838100. Epub 2019 Mar 26.
PubMed 31984235Amarenco P, Kim JS, Labreuche J, Charles H, Abtan J, Bejot Y, Cabrejo L, Cha JK, Ducrocq G, Giroud M, Guidoux C, Hobeanu C, Kim YJ, Lapergue B, Lavallee PC, Lee BC, Lee KB, Leys D, Mahagne MH, Meseguer E, Nighoghossian N, Pico F, Samson Y, Sibon I, Steg PG, Sung SM, Touboul PJ, Touze E, Varenne O, Vicaut E, Yelles N, Bruckert E; Treat Stroke to Target Investigators. A Comparison of Two LDL Cholesterol Targets after Ischemic Stroke. N Engl J Med. 2020 Jan 2;382(1):9. doi: 10.1056/NEJMoa1910355. Epub 2019 Nov 18.
PubMed 31738483
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF TWO SECONDARY CARE STRATEGIES AFTER STROKE OR TRANSIENT ISCHEMIC ATTACK (TIA): ACHEIVED TARGET LDL-C TO 100 mg/dL (+/- 10,mg/dL) OR LESS THAN 70 mg/dL.
- ClinicalTrials.gov ID
- NCT01252875
- Acronym / sponsor ID
- TST / P081244
- Keywords
- LDL-C, Cholesterol, Stroke, Transient ischemic attack, Statin, Lipid lowering therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,873 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Pfizer, AstraZeneca, Merck Sharp & Dohme LLC
- Study start
- 15 Mar 2010 (actual)
- Primary completion
- 26 May 2019 (actual)
- Study completion
- 26 May 2019 (actual)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is the evaluation of two usual care strategies after stroke or TIA : achieved target LDL-C of 100 mg/dL (+/-10 mg/dL) or less than 70 mg/dL. Investigators will use the statin and titrate the dosage to achieve the target assigned by randomization in monotherapy or in combination with ezetimibe or other drugs.
The primary end-point is the occurrence of recurrent non fatal stroke, non fatal MI, and vascular death in each group.
3760 patients will be recruited and followed for eight and a half years maximum.
Detailed description
The aim of this study is the evaluation of two usual care strategies after stroke or TIA : achieved target LDL-C of 100 mg/dL (+/-10 mg/dL) or less than 70 mg/dL. Investigators will use the statin and titrate the dosage to achieve the target assigned by randomization in monotherapy or in combination with ezetimibe or other drugs.
Inclusion criteria:
- Recent (less than 3 months) ischemic stroke As soon as possible after the event, once the neurologic deficit is stabilized (investigator judgment). These ischemic strokes include TIA with ischemic lesion documented by CT or MRI.
- Or recent TIA (less than 15 days) without documentation of ischemic lesion on CT/MR imaging. Must be limb weakness or aphasia lasting more than 10 min.
- And documented atherosclerotic stenosis in carotid artery (investigator judgment) (based on the results of Duplex echography, CTA, MRA or X ray- angiography), Or in the aortic arch (investigator judgment) (based on TEE or CTA), Or in other brain artery: vertebral, basilar or other intracranial artery (based on CTA, MRA, XRA), Or in coronary arteries (past history of acute coronary syndrome, coronary revascularization or positive coronary angiography)
- And statin treatment is indicated, following ANSM guidelines (French drug agency), age >18 years, rankin score ≤ 4, patient or a legal representative signs consent, patient is affiliated to social security system
Exclusion criteria :
- Ischemic stroke/TIA du to arterial dissection (investigator judgment)
- Cardiac source of embolism (e.g., mitral stenosis, endomyocardial fibrosis) without documented atherosclerotic stenosis : a patient with atrial fibrillation or a past history of recent myocardial infarction or calcified aortic stenosis can be randomized if he otherwise fulfils inclusion criteria
- Symptomatic hemorrhagic stroke : Presence of microbleeds on gradient echo imaging (T2*) is not an exclusion criteria. Hemorrhagic transformation of an ischemic stroke is not an exclusion criteria
- Uncontrolled hypertension (investigator judgment)
- LDL-C <100 mg/dL or patients for whom treatment intensification is impossible
- F/U impossible or bad observance anticipated.
- Co-morbid condition that may interfere with the F/U or with the evaluation of primary endpoint
- Participation to another clinical trial
The primary end-point is:
Recurrent ischemic stroke or stroke of undetermined origin, myocardial infarction, urgent coronary or carotid revascularization following new symptoms requiring hospitalization, and vascular death.
Secondary endpoints:
- Recurrent nonfatal ischemic stroke
- Nonfatal myocardial infarction
- Recurrent ischemic stroke, fatal or non
- Recurrent ischemic stroke or TIA
- Intracranial hemorrhage (intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma)
- All stroke (ischemic or hemorrhagic)
- Any major coronary events (including fatal and nonfatal myocardial infarction)
- Any coronary heart disease end-point (myocardial infarction, hospitalization for acute corornary symptoms, coronary revascularization procedure)
- Any revascularisation procedure (coronary, carotid, or peripheral artery))
- Carotid artery revascularization procedure (urgent following new symptoms or elective)
- Vascular death (ischemic stroke or undetermined stroke, fatal myocardial infarction, other vascular deaths, sudden death, death of undetermined cause, i.e., without other cause documented such as cancer, infection, accident, suicide, etc…)
- All causes deaths
- Primary endpoint plus intracranial hemorrhage
- New onset diabetes
Hypothesis :
- Follow-up of three years
- Risk of primary end-point in the control group (Target LDL <100 mg/dL) : 4% per year (12 % at 36 months)
- 5% Alpha, 80% power, total number of subject is :
- 3068 patients with a RRR 25%
- 20% drop-out: 3760 patients (385 primary EP)
Study specifications Follow-up : eight and a half years Follow-up visit : every 6 months Number of centers (French Stroke Units, under the auspice of the French Neurovascular Society) : 60-100
Ancillary study As an ancillary study, 800 patients (400 in each arm in 4 centers) will participate in the TST-PLUS (Plaque Ultrasound Study), in which they will have three ultrasound examination (baseline, 1 year and 3 years) and baseline blood sampling. The primary endpoint of this substudy will be the rate of occurrence of new carotid plaque, with the hypothesis that Rate of plaque occurrence in the <100 mg/dL group will be 25% after 3 years (45% in EVA when atherosclerosis was present at baseline) RRR of plaque of 25% in the <70 mg/dL group Alpha 5%, power 80%
As an ancillary study, 1000 patients will participate in the TST-PGS (Pharmacogenetics) Study, in which they will have 1 blood sampling either at baseline or during one of the follow-up visits of TST. The aim of this study is to show that the benefit (risk of ischemic stroke, myocardial infarction, and vascular death) observed with a strategy of LDL-C <0.7 g / l compared to a strategy of LDL-C to 1 ± 0.1 g / l is higher in carriers of polymorphism 719Arg of the gene KIF-6 than non-carriers of this polymorphism.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LDL-C to100 mg/dL (+/-10 mg/dL) | Other | Procedure: Target : 100 mg/dL (+/-10 mg/dL)Target : 100 mg/dL (+/-10 mg/dL): Patients recruited in this arm will receive statin +/-other lipid lowering therapy in order to reach a LDL-C concentration of 100 mg/dL(+/-10 mg/dL). |
| LDL-C < 70 mg/dL | Other | Procedure: 70 mg/dL70 mg/dL: Patients recruited in this arm will receive statin +/-other lipid lowering therapy in order to reach a LDL-C concentration of less than 70 mg/dL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- • Recent (less than 3 months) ischemic stroke
- As soon as possible after the event, once the neurologic deficit is stabilized (investigator judgment)
- These ischemic strokes include TIA with ischemic lesion documented by CT or MRI
- without documentation of ischemic lesion on CT/MR imaging
- Must be limb weakness or aphasia lasting more than 10 min
Key exclusion criteria (11 listed)
- • Ischemic stroke/TIA du to
- arterial dissection (investigator judgment)
- Cardiac source of embolism (e.g., mitral stenosis, endomyocardial fibrosis) without documented atherosclerotic stenosis : a patient with atrial fibrillation or a past history of recent myocardial infarction or calcified aortic stenosis can be randomized if he otherwise fulfils inclusion criteria
- Presence of microbleeds on gradient echo imaging (T2*) is not an exclusion criteria.
- Hemorrhagic transformation of an ischemic stroke is not an exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Target : 100 mg/dL (+/-10 mg/dL)Also: treat to targetStatin +/- other lipid lowering therapy during 3 years, Target : LDL-C =100 mg/dL (+/-10 mg/dL), recording recurrent non fatal stroke, non fatal MI, and vascular death and others endpoints such as new onset diabetes, hemorrhagic strokes. | Procedure or surgery | LDL-C to100 mg/dL (+/-10 mg/dL) |
| 70 mg/dLAlso: treat to targetStatin +/-lipid lowering therapy during eight and a half years maximum, Target : LDL-C concentration of less than 70 mg/dL, recording recurrent of non fatal stroke, non fatal IM, and vascular death and others endpoints such as: new onset diabetes, hemorrhagic strokes. | Procedure or surgery | LDL-C < 70 mg/dL |
Primary outcome
recurrent ischemic stroke or stroke of undetermined origin, myocardial infarction, urgent coronary or carotid revascularization following new symptoms requiring hospitalization, and vascular death.
Time frame: each 6 months
recurrent ischemic stroke or stroke of undetermined origin, myocardial infarction, urgent coronary or carotid revascularization following new symptoms requiring hospitalization, and vascular death.
14 secondary outcomes
Recurrent nonfatal ischemic stroke
Time frame: each 6 months
Nonfatal myocardial infarction
Time frame: each 6 months
Recurrent ischemic stroke, fatal or non
Time frame: each 6 months
Recurrent ischemic stroke or TIA
Time frame: each 6 months
Intracranial hemorrhage (intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma)
Time frame: each three weeks until target is not achieved then each 6 months
All stroke (ischemic or hemorrhagic)
Time frame: each three weeks until target is not achieved then each 6 months
Any major coronary events (including fatal and nonfatal myocardial infarction)
Time frame: each 6 months
Any coronary heart disease end-point (myocardial infarction, hospitalization for acute corornary symptoms, coronary revascularization procedure)
Time frame: each 6 months
Any revascularisation procedure (coronary, carotid, or peripheral artery))
Time frame: each 6 months
Carotid artery revascularization procedure (urgent following new symptoms or elective)
Time frame: each 6 months
Vascular death (ischemic stroke or undetermined stroke, fatal myocardial infarction, other vascular deaths, sudden death, death of undetermined cause, i.e., without other cause documented such as cancer, infection, accident, suicide, etc…)
Time frame: each 6 months
All causes deaths
Time frame: each 6 months
Primary endpoint plus intracranial hemorrhage
Time frame: each 6 months
New onset diabetes
Time frame: each 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Derived from this study: PubMed 37376989Amarenco P, Lavallee PC, Kim JS, Labreuche J, Charles H, Giroud M, Lee BC, Mahagne MH, Meseguer E, Nighoghossian N, Steg PG, Vicaut E, Bruckert E; Treat Stroke to Target Investigators. More Than 50 Percent Reduction in LDL Cholesterol in Patients With Target LDL <70 mg/dL After a Stroke. Stroke. 2023 Aug;54(8):1993-2001. doi: 10.1161/STROKEAHA.123.042621. Epub 2023 Jun 28.
- Derived from this study: PubMed 36154103Amarenco P, Kim JS, Labreuche J, Charles H, Giroud M, Lee BC, Lavallee PC, Mahagne MH, Meseguer E, Nighoghossian N, Steg PG, Vicaut E, Bruckert E; Treat Stroke to Target Investigators. Yield of Dual Therapy With Statin and Ezetimibe in the Treat Stroke to Target Trial. Stroke. 2022 Nov;53(11):3260-3267. doi: 10.1161/STROKEAHA.122.039728. Epub 2022 Sep 26.
- Derived from this study: PubMed 34963300Amarenco P, Kim JS, Labreuche J, Charles H, Giroud M, Lavallee PC, Lee BC, Mahagne MH, Meseguer E, Nighoghossian N, Steg PG, Vicaut E, Bruckert E; Treat Stroke to Target Investigators*. Intracranial Hemorrhage in the TST Trial. Stroke. 2022 Feb;53(2):457-462. doi: 10.1161/STROKEAHA.121.035846. Epub 2021 Dec 29.
- Derived from this study: PubMed 33980690Amarenco P, Kim JS, Labreuche J, Charles H, Giroud M, Lee BC, Lavallee PC, Mahagne MH, Meseguer E, Nighoghossian N, Steg PG, Vicaut E, Bruckert E; Treat Stroke to Target Investigators; Treat Stroke to Target investigators:. Impact of Lower Versus Higher LDL Cholesterol Targets on Cardiovascular Events After Ischemic Stroke in Patients With Diabetes. Diabetes. 2021 Aug;70(8):1807-1815. doi: 10.2337/db21-0302. Epub 2021 May 12.
- Derived from this study: PubMed 32594766Amarenco P, Hobeanu C, Labreuche J, Charles H, Giroud M, Meseguer E, Lavallee PC, Gabriel Steg P, Vicaut E, Bruckert E, Touboul PJ. Carotid Atherosclerosis Evolution When Targeting a Low-Density Lipoprotein Cholesterol Concentration <70 mg/dL After an Ischemic Stroke of Atherosclerotic Origin. Circulation. 2020 Aug 25;142(8):748-757. doi: 10.1161/CIRCULATIONAHA.120.046774. Epub 2020 Jun 29.
- Derived from this study: PubMed 32078484Amarenco P, Kim JS, Labreuche J, Charles H, Giroud M, Lee BC, Mahagne MH, Nighoghossian N, Gabriel Steg P, Vicaut E, Bruckert E; Treat Stroke to Target Investigators. Benefit of Targeting a LDL (Low-Density Lipoprotein) Cholesterol <70 mg/dL During 5 Years After Ischemic Stroke. Stroke. 2020 Apr;51(4):1231-1239. doi: 10.1161/STROKEAHA.119.028718. Epub 2020 Feb 20.
- Derived from this study: PubMed 31984235Amarenco P, Kim JS, Labreuche J, Giroud M, Lee BC, Mahagne MH, Nighoghossian N, Simon T, Steg PG, Touboul PJ, Vicaut E, Yelles N, Bruckert E. Treat stroke to target trial design: First trial comparing two LDL targets in patients with atherothrombotic strokes. Eur Stroke J. 2019 Sep;4(3):271-280. doi: 10.1177/2396987319838100. Epub 2019 Mar 26.
- Derived from this study: PubMed 31738483Amarenco P, Kim JS, Labreuche J, Charles H, Abtan J, Bejot Y, Cabrejo L, Cha JK, Ducrocq G, Giroud M, Guidoux C, Hobeanu C, Kim YJ, Lapergue B, Lavallee PC, Lee BC, Lee KB, Leys D, Mahagne MH, Meseguer E, Nighoghossian N, Pico F, Samson Y, Sibon I, Steg PG, Sung SM, Touboul PJ, Touze E, Varenne O, Vicaut E, Yelles N, Bruckert E; Treat Stroke to Target Investigators. A Comparison of Two LDL Cholesterol Targets after Ischemic Stroke. N Engl J Med. 2020 Jan 2;382(1):9. doi: 10.1056/NEJMoa1910355. Epub 2019 Nov 18.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Amarenco, MD principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Target : 100 mg/dL (+/-10 mg/dL) and 70 mg/dL in people with Ischemic Stroke and Transient Ischemic Attack, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrent ischemic stroke or stroke of undetermined origin, myocardial infarction, urgent coronary or carotid revascularization following new symptoms requiring hospitalization, and vascular death. (time frame: each 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01252875, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019; AzTrials last refreshed its copy on 1 Nov 2026.