Background and Purpose—
High rates of ischemic stroke and poor adherence to secondary prevention measures are observed in the Chinese population.
Methods—
We used a national, multicenter, cluster-randomized controlled trial in which 47 hospitals were randomized to either a structured care program group (n=23) or a usual care group (n=24). The structured care program consisted of a specialist-administered, guideline-recommended pharmaceutical treatment and a lifestyle modification algorithm associated with written and Internet-accessed educational material for patients for the secondary prevention of ischemic stroke. The primary efficacy outcome was the proportion of patients who adhered to the recommended measures at 12-month postdischarge. This trial is registered with ClinicalTrial.gov (NCT00664846).
Results—
At 12 months, 1287 (72.1%) patients in the Standard Medical Management in Secondary Prevention of Ischemic Stroke in China (SMART) group and 1430 (72%) patients in the usual care group had completed the 12-month follow-up (
P
=0.342). Compared with the usual care group, those in the SMART group showed higher adherence to statins (56% versus 33%;
P
=0.006) but no difference in adherence to antiplatelet (81% versus 75%;
P
=0.088), antihypertensive (67% versus 69%;
P
=0.661), or diabetes mellitus drugs (73% versus 67%;
P
=0.297). No significant difference in the composite end point (new-onset ischemic stroke, hemorrhagic stroke, acute coronary syndrome, and all-cause death) was observed (3.56% versus 3.59%;
P
=0.921).
Conclusions—
The implementation of a program to improve adherence to secondary ischemic stroke prevention efforts in China is feasible, but these programs had only a limited impact on adherence and no impact on 1-year outcomes. Further development of a structured program to reduce vascular events after stroke is needed.
Clinical Trial Registration—URL:
http://www.clinicaltrials.gov
. Unique identifier: NCT00664846.
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