Secondary prevention by structured semi-interactive stroke prevention package in India (SPRINT - INDIA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,830
- 试验地点
- 31
- 主要终点
- Primary outcome measure is a composite endpoint of recurrent stroke, high-risk transient ischemic attack, acute coronary syndrome, and death.
研究概览
简要总结
Recurrent stroke, cardiovascular morbidityand mortality are important causes of poor outcome in patients with indexstroke. According to INTERSTROKE study 80% of stroke are preventable due topresence of modifiable risk factors. However lack of knowledge that stroke andcardiovascular diseases are preventable is major hurdle to reduce the incidenceof recurrent stroke and cardiovascular morbidity. This is further compounded bythe non-compliance to medications, exercises smoking cessationand otherlifestyle modifications.
Stroke awareness has proven to be useful inimproving early arrival of stroke patients to emergency thus increasing thethrombolysis rates. Early stroke prevention education using print andaudio-visual media may be useful. In addition the use of pervasive mobile phoneplatform may help us reach patients during multiple intervals in a timelymanner.
We aim to use structured semi-interactivestroke prevention package to reduce the risk of recurrent strokes, myocardialinfarction and death in patients with sub-acute stroke after one month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age ≥18 years (at the time of suffering stroke) including both men and women and there is no upper age limit 2.First ever Ischemic stroke or intracerebral haemorrhage 3.Between 2 days-3 months of stroke symptom onset 4.Modified Rankin scale score ≥2 at the time of enrolment.
排除标准
- •1.Modified Rankin scale score 0 and 1 at the time of enrolment 2.Limited internet and/or mobile accessibility due to travel 3.Patients having active malignancies needing intensive therapy 4.Patients with terminal illness with an anticipated lifespan of less than 1 year 5.Patients with heart failure admitted more than twice in last six months 6.Patients with current psychiatric illness with loss of insight and suicide attempts 7.Patients with cerebral venous sinus thrombosis, aneurysmal subarachnoid hemorrhage, isolated central nervous system vasculitis and systemic vasculitis.
结局指标
主要结局
Primary outcome measure is a composite endpoint of recurrent stroke, high-risk transient ischemic attack, acute coronary syndrome, and death.
时间窗: 1 year
次要结局
- secondary outcome measures are blood pressure (mmHg), fasting blood glucose (mg/dl), LDL Cholesterol (mg/dl), triglycerides (mg/dl), smoking cessation (No/ total %), alcohol cessation, body mass index, physical activity MET (min/week), medication adherence and modified Rankin scale (mRS)(1 year)