Ischemic Stroke Clinical Trial
— TSTOfficial 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.
NCT number | NCT01252875 |
Other study ID # | P081244 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 15, 2010 |
Est. completion date | May 26, 2019 |
Verified date | June 2019 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 2873 |
Est. completion date | May 26, 2019 |
Est. primary completion date | May 26, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | BICHAT HOSPITAL Departement of Neurology | Paris | |
France | BICHAT HOSPITAL Department of neurology and stroke center | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | AstraZeneca, Merck Sharp & Dohme Corp., Pfizer |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | each 6 months | |
Secondary | Recurrent nonfatal ischemic stroke | Recurrent nonfatal ischemic stroke | each 6 months | |
Secondary | Nonfatal myocardial infarction | Nonfatal myocardial infarction | each 6 months | |
Secondary | Recurrent ischemic stroke, fatal or non | Recurrent ischemic stroke, fatal or non | each 6 months | |
Secondary | Recurrent ischemic stroke or TIA | Recurrent ischemic stroke or TIA | each 6 months | |
Secondary | Intracranial hemorrhage (intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma) | Intracranial hemorrhage (intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma) | each three weeks until target is not achieved then each 6 months | |
Secondary | All stroke (ischemic or hemorrhagic) | All stroke (ischemic or hemorrhagic) | each three weeks until target is not achieved then each 6 months | |
Secondary | Any major coronary events (including fatal and nonfatal myocardial infarction) | Any major coronary events (including fatal and nonfatal myocardial infarction) | each 6 months | |
Secondary | 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) | each 6 months | |
Secondary | Any revascularisation procedure (coronary, carotid, or peripheral artery)) | Any revascularisation procedure (coronary, carotid, or peripheral artery)) | each 6 months | |
Secondary | Carotid artery revascularization procedure (urgent following new symptoms or elective) | Carotid artery revascularization procedure (urgent following new symptoms or elective) | each 6 months | |
Secondary | 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…) | each 6 months | |
Secondary | All causes deaths | All causes deaths | each 6 months | |
Secondary | Primary endpoint plus intracranial hemorrhage | Primary endpoint plus intracranial hemorrhage | each 6 months | |
Secondary | New onset diabetes | New onset diabetes | each 6 months |
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