None listed
Conditions
Interventions
Drug : Randomized, controlled trial, 1:1, into two therapeutic strategies, using open-labeled marketed FDA/EMA/ANSM approved drug, prescribed by investigators in 100 neurologic centers.
3760 patients
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. patient with: a. recent (<3 months) cerebral infartion, once the neurologic deficit is deemed stabilized following investigator judgment b. or recent (<15 days) transient ischemic attack with at least either paralysis of arm or leg or both, or aphasia, lasting at least 10 minutes, c. or a recent (<3 months) TIA asswoiated with ischemic lesion as demonstrated by CT or MRI located in a cerebral area compatible with the transient neurologic deficit. 2. with documented atherosclerotic disease : a presence of carotid atherosclerosis (as diagnosed by carotid duplex or CT- angiographie or MR-angiography, or X-ray angiography) b or presence of atherosclerosis in the aortic arch (as diagnosed by transesophageal echocardiography or CT-angiography) c or presence of atherosclerotic disease in another cerebral artey (vertebral, basilar or other intra-cranial artery stenosis) d or existence of a past-history of symptomatic coronary artery disease (myocardial infarction, coronary artery revascularization or chest pain with positive coronary angiography) 3. with a clinical indication of statin treatment according to country recommendation 4. Age equal or above 20 5. With a Rankin score equal or less than 4 6. Patient has signed an informed consent 7. Women of childbearing potential, should be on effective contraception
Exclusion criteria
Exclusion criteria: 1. Ischemic stroke/TIA due to cerebral artery dissection (as documented following the judgment of the investigator) or to a cardiac source of embolism (as documented following the judgment of the investigator) without atherosclerotic disease being present (e.g., mitral stenosis, endomyocardial fibrosis). For example a patient with atrial fibrillation or a past history of myocardial infarction or an aortic stenosis would be elligible if he/she satisfies the above inclusion criteria. 2. Symptomatic brain hemorrhage (the mere presence of microbleeds on gradient echo imaging is not an exclusion criteria) 3. Uncontrolled hypertension (following the judgment of the lnvestigator) 4. Patient with a LDL-C less than 100 mg/dL while NOT treated by statin (i.e., a patient having LDL-C less than 100 mg/dL on statin treatment prior the qualifying stroke/TIA can be randomized and then the statin dosage being titrated to the assigned target LDL-C level), or patient for whom intensification of statin treatment is impossible. 5. Intercurrent or concomittant disease that precludes a follow-up visits or that can interfere with endpoints evaluation. 6. Intercurrent disease that may interfere with evaluation of the primary end-point or that may prevent follow-up study visits(e.g. Disseminated intravascular coagulation syndrome, Hematologic malignancy, Malignancy) 7. Participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of: recurrent ischemic stroke, or stroke of undetermined origin, myocardial infarction, urgent coronary or carotid revascularization following new symptoms requiring hospitalization and vascular death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrent fatal and nonfatal ischemic stroke | — |
Countries
Korea, Republic of
Contacts
Public ContactDalnim Seo
Asan Medical Center
Outcome results
None listed