EVALUATION OF TWO STRATEGIES IN SECONDARY PREVENTION OF STROKE/TIA: LDL-C LOWERING TO 100±10 MG/DL OR TO <70 MG/D
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0003337
- Lead Sponsor
- Asan Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 714
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 :
apresence of carotid atherosclerosis (as diagnosed by carotid duplex or CT-
angiographie or MR-angiography, or X-ray angiography)
bor presence of atherosclerosis in the aortic arch (as diagnosed by
transesophageal echocardiography or CT-angiography)
cor 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
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Recurrent fatal and nonfatal ischemic stroke