Reducing the Burden of Cardiovascular Events With Antiplatelet Therapy in Patients With IntraCerebral Haemorrhage.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5,676
- 试验地点
- 90
- 主要终点
- Major Adverse Cardiovascular Events (MACE)
研究概览
简要总结
BEAT ICH will be a pragmatic, randomised, placebo-controlled, blinded, superiority clinical trial aiming to recruit 5676 patients aged ≥18 years who survive ICH and assign them 1:1 to starting antiplatelet monotherapy (Aspirin 75 mg od) versus placebo for the entire duration of the trial for preventing MACE. Recruitment duration is for 2.5 years. The duration of the medication and follow-up will vary based on recruitment timeline. If recruited during the first year of the trial, the patient will take the medication for three years or until the trial ends or an event occurs, with a matching follow-up period. If recruited towards the end of the trial, he/she will take the medication for six months and be followed up for the same duration. The trial's follow-up duration is three years. The patients will be recruited for 2.5 years, and the last recruit will have a minimum follow-up of six months. No new patients will be recruited within the last six months of the trial, but all the patients will be followed up until the end of the trial.
详细描述
Stroke is the second leading cause of death and disability globally. Intracerebral haemorrhage (ICH) accounts for 10% to 15% of strokes in high-income countries and 20% to 50% in developing countries. The proportion of ICH ranges from 19% to 41% in India and is higher in Eastern India. Recurrent stroke rates are high worldwide; 15% in India (Kolkata), 41% in China, 6 and 13% in Taiwan.
ICH patients are at a risk of recurrent stroke (ICH and ischaemic) and other serious cardiovascular events, and yet there is no consensus regarding starting antiplatelet drugs for secondary prevention. RESTART is the only trial (pilot) that studied antiplatelet therapy and showed a decrease in recurrent ICH compared to no antiplatelet therapy, with a median follow-up of 2 years (IQR [1·0-3·0]). The recurrence rates were 4% in the intervention group versus 9% in the control group. There is no large stroke trial which has addressed this question.
Hence, plan is to initiate the BEAT-ICH trial, a randomized placebo-controlled trial of ICH patients where intervention arm patients will receive antiplatelet monotherapy (Aspirin 75mg) and the control arm will receive a placebo. The primary outcome will be determining whether antiplatelet monotherapy provides a net reduction in major adverse cardiovascular and cerebrovascular events (MACE) in the long term in ICH patients.
Trial Population:
This multi-centric study will be conducted at 50 stroke centres in India associated with the INSTRuCT Network. All patients presenting with symptoms of stroke to the hospital and admitted to the stroke units will be screened for eligibility and if met, will be included in the study. The BEAT ICH trial intends to recruit 5676 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •First-ever Intracerebral Haemorrhage
- •Presenting ≥24 hrs up to 3 months of stroke symptoms confirmed by brain imaging
- •CT /MRI confirming Intracerebral Haemorrhage
- •Alive ≥24 hours after non-traumatic ICH
排除标准
- •ICH is known to be due to trauma, a structural cause (e.g., aneurysm, arteriovenous malformation, cerebral cavernous malformation, venous thrombosis, or tumour), or haemorrhagic transformation of cerebral infarction
- •Glasgow coma score ≤5
- •Taking any antiplatelet or anticoagulant therapy 15 days prior to randomization.
- •Women pregnant, breastfeeding, childbearing potential, and not using contraceptives
- •Enrolled in any other clinical trial
- •Sick or compromised patients with life expectancy of less than a year
- •Geographical or other factors that prohibit long-term follow-up
研究组 & 干预措施
Placebo
The control arm is placebo, which will be look-alike both as kits and tablets and will be prescribed in the same way as Aspirin: OD along with the standard secondary prevention after ICH.
干预措施: Placebo (Drug)
Aspirin 75 mg OD
The intervention is oral daily Aspirin 75 mg OD (antiplatelet drug monotherapy) in addition to standard care for secondary prevention after ICH based on the universal guidelines.
干预措施: Aspirin 75 mg daily (Drug)
结局指标
主要结局
Major Adverse Cardiovascular Events (MACE)
时间窗: 3 years
To reduce the risk of first MACE (stroke, myocardial infarction, hospitalisation, or death) with antiplatelet monotherapy in ICH patients. The components of the MACE include ischemic stroke, haemorrhagic stroke, hospitalisation due to stroke (ischemic, haemorrhagic, subarachnoid haemorrhage), myocardial infarction, coronary artery disease, cerebral and cardiovascular death due to any vascular causes (including pulmonary embolism, gastrointestinal haemorrhage) or death due to non-Cerebrovascular and cardiovascular causes.
MACE
时间窗: 3 years
To reduce the risk of first MACE (stroke, myocardial infarction, hospitalisation, or death) with antiplatelet monotherapy in ICH patients. The components of the MACE include ischemic stroke, haemorrhagic stroke, hospitalisation due to stroke (ischemic, haemorrhagic, subarachnoid haemorrhage), myocardial infarction, coronary artery disease, cerebral and cardiovascular death due to any vascular causes (including pulmonary embolism, gastrointestinal haemorrhage) or death due to non-Cerebrovascular and cardiovascular causes.
次要结局
- Medication adherence(3 years (every 3 months) till study end)
- Major bleeding(3 years)
- modified Rankin Scale(3 years (every 3 months) till study end)
- major bleeding(3 years)
- Medication adherence(3 years (every 3 months) till study end)
- mRS (modified Rankin Scale)(3 years (every 3 months) till study end)
研究者
Jeyaraj D Pandian
Principal and Professor, Department of Neurology
Christian Medical College and Hospital, Ludhiana, India