EVALUATION OF TWO STRATEGIES IN SECONDARY PREVENTION OF STROKE/TIA: LDL-C LOWERING TO 100±10 MG/DL OR TO <70 MG/D
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Asan Medical Center
- Enrollment
- 714
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
A total of 2860 patients were enrolled and followed for a median of 3.5 years; 1430 were assigned to each LDL cholesterol target group. The mean LDL cholesterol level at baseline was 135 mg per deciliter (3.5 mmol per liter), and the mean achieved LDL cholesterol level was 65 mg per deciliter (1.7 mmol per liter) in the lower-target group and 96 mg per deciliter (2.5 mmol per liter) in the higher-target group. The trial was stopped for administrative reasons after 277 of an anticipated 385 end-point events had occurred. The composite primary end point occurred in 121 patients (8.5%) in the lower-target group and in 156 (10.9%) in the higher-target group (adjusted hazard ratio, 0.78; 95% confidence interval, 0.61 to 0.98; P=0.04). The incidence of intracranial hemorrhage and newly diagnosed diabetes did not differ significantly between the two groups.
Investigators
Eligibility 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
- •2\. with documented atherosclerotic disease :
- •apresence of carotid atherosclerosis (as diagnosed by carotid duplex or CT\-
- •angiographie or MR\-angiography, or X\-ray angiography)
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
Outcomes
Primary Outcomes
Not specified