Hansson L, Lithell H, Skoog I, Baro F, Bánki C M, Breteler M, Carbonin P U, Castaigne A, Correia M, Degaute J P, Elmfeldt D, Engedal K, Farsang C, Ferro J, Hachinski V, Hofman A, James O F, Krisin E, Leeman M, de Leeuw P W, Leys D, Lobo A, Nordby G, Olofsson B, Zanchetti A
University of Uppsala, Department of Public Health, Sweden.
Blood Press. 1999;8(3):177-83. doi: 10.1080/080370599439715.
The Study on COgnition and Prognosis in the Elderly (SCOPE) is a multicentre, prospective, randomized, double-blind, parallel-group study designed to compare the effects of candesartan cilexetil and placebo in elderly patients with mild hypertension. The primary objective of the study is to assess the effect of candesartan cilexetil on major cardiovascular events. The secondary objectives of the study are to assess the effect of candesartan cilexetil on cognitive function and on total mortality, cardiovascular mortality, myocardial infarction, stroke, renal function, hospitalization, quality of life and health economics. Male and female patients aged between 70 and 89 years, with a sitting systolic blood pressure (SBP) of 160-179 mmHg and/or diastolic blood pressure (DBP) of 90-99 mmHg, and a Mini-Mental State Examination (MMSE) score of 24 or above, are eligible for the study. The overall target study population is 4000 patients, at least 1000 of whom are also to be assessed for quality of life and health economics data. After an open run-in period lasting 1-3 months, during which patients are assessed for eligibility and those who are already on antihypertensive therapy at enrolment are switched to hydrochlorothiazide 12.5 mg o.d., patients are randomized to receive either candesartan cilexetil 8 mg once daily (o.d.) or matching placebo o.d. At subsequent study visits, if SBP remains >160 mmHg, or has decreased by <10 mmHg since the randomization visit, or DBP is >85 mmHg, study treatment is doubled to candesartan cilexetil 16 mg o.d. or two placebo tablets o.d. Recruitment was completed in January 1999. At that time 4964 patients had been randomized. All randomized patients will be followed for an additional 2 years. If the event rate is lower than anticipated, the follow-up will be prolonged.
老年人认知与预后研究（SCOPE）是一项多中心、前瞻性、随机、双盲、平行组研究，旨在比较坎地沙坦酯与安慰剂对老年轻度高血压患者的影响。该研究的主要目的是评估坎地沙坦酯对主要心血管事件的影响。研究的次要目的是评估坎地沙坦酯对认知功能、总死亡率、心血管死亡率、心肌梗死、中风、肾功能、住院率、生活质量和健康经济学的影响。年龄在70至89岁之间，坐位收缩压（SBP）为160 - 179 mmHg和/或舒张压（DBP）为90 - 99 mmHg，且简易精神状态检查表（MMSE）评分在24分及以上的男性和女性患者符合该研究条件。研究的总体目标人群为4000名患者，其中至少1000名患者还将接受生活质量和健康经济学数据评估。在为期1 - 3个月的开放导入期内，评估患者是否符合条件，入组时已接受抗高血压治疗的患者改用氢氯噻嗪12.5 mg每日一次（o.d.），之后患者被随机分配接受坎地沙坦酯8 mg每日一次（o.d.）或匹配的安慰剂o.d.。在随后的研究访视中，如果SBP仍>160 mmHg，或自随机分组访视后下降幅度<10 mmHg，或DBP>85 mmHg，则将研究治疗剂量加倍至坎地沙坦酯16 mg o.d.或两片安慰剂o.d.。招募工作于1999年1月完成。当时已有4964名患者被随机分组。所有随机分组的患者将再随访2年。如果事件发生率低于预期，随访时间将延长。
