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- • 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
- • 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
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Descriptive Information | ||||
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Brief Title ICMJE | Treat Stroke to Target | |||
Official Title ICMJE | 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. | |||
Brief 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 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:
Exclusion criteria :
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:
Hypothesis :
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 Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 2873 | |||
Original Estimated Enrollment ICMJE | 3760 | |||
Actual Study Completion Date ICMJE | May 26, 2019 | |||
Actual Primary Completion Date | May 26, 2019 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01252875 | |||
Other Study ID Numbers ICMJE | P081244 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | Assistance Publique - Hôpitaux de Paris | |||
Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Assistance Publique - Hôpitaux de Paris | |||
Verification Date | June 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |