KCT0003337已完成未知
EVALUATION OF TWO STRATEGIES IN SECONDARY PREVENTION OF STROKE/TIA: LDL-C LOWERING TO 100±10 MG/DL OR TO <70 MG/D
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 714
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •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)
- •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
排除标准
- •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.
研究者
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