Lancet Glob Health. 2023 Mar;11(3):e425-e435. doi: 10.1016/S2214-109X(22)00544-7.
There is a high burden of stroke, including recurrent stroke, in India. We aimed to assess the effect of a structured semi-interactive stroke prevention package in patients with subacute stroke to reduce recurrent strokes, myocardial infarction, and death.
This was a multicentre, randomised, clinical trial conducted in 31 centres of the Indian Stroke Clinical Trial Network (INSTRuCT). Adult patients with first stroke and access to a mobile cellular device were randomly allocated (1:1) to intervention and control groups by the research coordinators at each centre using a central, in-house, web-based randomisation system. The participants and research coordinators at each centre were not masked to group assignment. The intervention group received regular short SMS messages and videos that promoted risk factor control and medication adherence and an educational workbook, in one of 12 languages, and the control group received standard care. The primary outcome was a composite of recurrent stroke, high-risk transient ischaemic attack, acute coronary syndrome, and death at 1 year. The outcome and safety analyses were done in the intention-to-treat population. The trial is registered with ClinicalTrials.gov, NCT03228979 and Clinical Trials Registry-India (CTRI/2017/09/009600) and was stopped for futility after interim analysis.
Between April 28, 2018, and Nov 30, 2021, 5640 patients were assessed for eligibility. 4298 patients were randomised to the intervention group (n=2148) or control group (n=2150). 620 patients were not followed up at 6 months and a further 595 patients were not followed up at 1 year because the trial was stopped for futility after interim analysis. 45 patients were lost to follow-up before 1 year. Acknowledgment of receipt of the SMS messages and videos by the intervention group patients was low (17%). The primary outcome occurred in 119 (5·5%) of 2148 patients in the intervention group and 106 (4·9%) of 2150 patients in the control group (adjusted odds ratio 1·12; 95% CI 0·85-1·47; p=0·370). Among the secondary outcome measures, alcohol cessation and smoking cessation were higher in the intervention group than in the control group (alcohol cessation 231 [85%] of 272 in the intervention group vs 255 [78%] of 326 in the control group; p=0·036; smoking cessation 202 [83%] vs 206 [75%]; p=0·035). Medication compliance was better in the intervention group than in the control group (1406 [93·6%] of 1502 vs 1379 [89·8%] of 1536; p<0·001). There was no significant difference between the two groups in other secondary outcome measures at 1 year: blood pressure, fasting blood sugar (mg/dL), low-density lipoprotein cholesterol (mg/dL), and triglycerides (mg/dL), BMI, modified Rankin Scale, and physical activity.
A structured semi-interactive stroke prevention package did not reduce vascular events when compared with standard care. However, there was an improvement in some lifestyle behavioural factors, including adherence to medication, which might have long-term benefits. There was a possibility of type 2 error owing to reduced power since there were fewer events and a high number of patients could not be followed up.
Indian Council of Medical Research.
印度中风负担沉重，包括复发性中风。我们旨在评估结构化半互动性中风预防方案在亚急性中风患者中的效果，以降低复发性中风、心肌梗死和死亡的风险。
这是一项在印度中风临床研究网络（INSTRuCT）的 31 个中心进行的多中心、随机、临床试验。首次中风且可使用移动通讯设备的成年患者通过每个中心的研究协调员，使用内部中央网络随机分配（1:1）到干预组和对照组。参与者和每个中心的研究协调员均无法对分组情况进行设盲。干预组定期收到促进危险因素控制和药物依从性的短 SMS 消息和视频以及一本 12 种语言之一的教育手册，对照组则接受标准护理。主要结局是 1 年内复发性中风、高危短暂性脑缺血发作、急性冠状动脉综合征和死亡的复合结局。意向治疗人群进行结局和安全性分析。该试验在 ClinicalTrials.gov、Clinical Trials Registry-India（CTRI/2017/09/009600）和 ClinicalTrials.gov 注册，中期分析后因无效而停止。
2018 年 4 月 28 日至 2021 年 11 月 30 日，对 5640 名患者进行了入选评估。4298 名患者被随机分配到干预组（n=2148）或对照组（n=2150）。620 名患者在 6 个月时未随访，另有 595 名患者在 1 年时未随访，因为中期分析后因无效而停止了试验。45 名患者在 1 年前失访。干预组患者对 SMS 消息和视频的接收确认率较低（17%）。干预组 2148 名患者中有 119 名（5.5%）和对照组 2150 名患者中有 106 名（4.9%）发生了主要结局（调整后的优势比 1.12；95%CI 0.85-1.47；p=0.370）。在次要结局指标中，干预组的戒酒和戒烟率高于对照组（干预组 272 名患者中有 231 名（85%）戒酒，而对照组 326 名患者中有 255 名（78%）戒酒；p=0.036；干预组 202 名患者中有 206 名（83%）戒烟，而对照组 206 名患者中有 206 名（75%）戒烟；p=0.035）。干预组的药物依从性优于对照组（1502 名患者中有 1406 名（93.6%），而对照组 1536 名患者中有 1379 名（89.8%）；p<0.001）。两组在 1 年内的其他次要结局指标没有显著差异：血压、空腹血糖（mg/dL）、低密度脂蛋白胆固醇（mg/dL）和甘油三酯（mg/dL）、BMI、改良 Rankin 量表和体力活动。
与标准护理相比，结构化半互动性中风预防方案并未降低血管事件。然而，一些生活方式行为因素有所改善，包括对药物的依从性，这可能带来长期益处。由于事件较少且有大量患者无法随访，因此存在 II 型错误的可能性。
印度医学研究理事会。
