CRUCIAL 2011.
Methods | Open label, cluster‐randomised trial | |
Participants | 136 clusters; 1461 total participants (779 intervention; 682 comparator participants) from 19 countries (Costa Rica, Croatia, Czech Republic, Dominican Republic, Indonesia, Jordan, Kuwait, Lebanon, Malaysia, Mexico, Panama, Philippines, South Korea, Russia, Taiwan, Thailand, Turkey, United Arab Emirates, Venezuela) Men and women aged 35‐79 years with hypertension and total cholesterol < 250 mg/dL plus 3 or more risk factors (current smoker, peripheral artery disease, type 2 diabetes, family history of early CHD before aged 55 years in first‐degree relative; left ventricular hypertrophy on ECG; history of transient ischaemic attack or stroke three or more months prior to screening; ECG abnormalities; age > 55 years (men) or > 65 years (women), total cholesterol > 250mg/dL, or HDL < 40mg/dL) |
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Interventions | Intervention: single pill amlodipine/atorvastatin (5 mg/10 mg‐10 mg/10 mg; site investigators could request dosages of 5/20 mg and 10/20 mg) in addition to other hypertensive/lipid‐lowering therapy as required, as well as therapeutic lifestyle counselling change Comparator: usual care, including therapeutic lifestyle counselling change |
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Outcomes | SBP, DBP, LDL‐C, total cholesterol; all‐cause mortality reported | |
Notes | Comparator: inactive/usual care | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Investigators ‐ randomly assigned", "randomisation was stratified", "investigator as unit of randomisation" |
Allocation concealment (selection bias) | Unclear risk | Due to cluster randomisation |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open label |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open label |
Incomplete outcome data (attrition bias) All outcomes | High risk | 93/779 (11.9%) discontinued intervention; 44/682 (6.5%) discontinued in usual care arm |
Selective reporting (reporting bias) | Unclear risk | Not all outcomes available for meta‐analysis |
Other bias | Unclear risk | Differences between two arms in terms of baseline blood pressure, ECG abnormalities, PVD |