Aspirin With a Novel Twice-a-day Administration in Diabetic Patients With Acute Coronary Syndrome to Minimize Recurrence of Acute Ischemic Events or New Urgent Revascularization
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,484
- 试验地点
- 1
- 主要终点
- first main vascular event occurring within the 18 months after randomization among the following: Death (any), Myocardial infarction, Stroke, Urgent coronary revascularization and/or stent thrombosis, Acute arterial thrombotic event
研究概览
简要总结
To compare treatment with Aspirin Protect® twice a day (100 mg in the morning and 100 mg in the evening) versus Aspirin Protect® 100 mg once per day on a composite end-point of ischemic events in diabetic patients, or in patients with a known risk factor for non-optimal aspirin response (obesity, abdominal obesity or coronary event occurring with long-term aspirin),with acute coronary syndrome. It is expected that aspirin taken twice a day will reduce the occurrence of new ischemic event after acute coronary syndrome in diabetic patients or in patients with a known risk factor.
详细描述
Patients who show high persistent platelet reactivity under aspirin are increasingly becoming an issue of clinical concern. Several studies have suggested that giving aspirin more frequently is very effective for reducing aspirin high persistent platelet reactivity, especially in diabetic patientsor in patients with a known risk factor. The aim of the study is to evaluate low dose of aspirin twice a day (compared to once a day) for the reduction of ischemic events in diabetic patients or in patients with a known risk factor, with acute coronary syndrome.
Experimental Design:
A multicenter, randomised, parallel group comparing aspirin given twice a day compared to once per day in diabetic patients, or in patients with a known risk factor for non-optimal aspirin response (obesity, abdominal obesity or coronary event occurring with long-term aspirin),with acute coronary syndrome.
Primary objective:
To compare treatment with Aspirin Protect® twice a day (100 mg in the morning and 100 mg in the evening) versus Aspirin Protect® 100 mg once per day on a composite end-point of ischemic events in diabetic patients, or in patients with a known risk factor for non-optimal aspirin response (obesity, abdominal obesity or coronary event occurring with long-term aspirin),with acute coronary syndrome.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus defined as (≥ 1 item)
- •Treated diabetes mellitus
- •2 fasting glucose levels ≥ 7 mmol/l after admission
- •glucose level ≥ 11 mmol/l after admission (any moment)
- •HbA1C ≥ 6.5% OR
- •Factor of aspirin lack of efficacy defined as (≥ 1 item)
- •Obesity defined as BMI≥27kg/m2
- •Waist circumference ≥ 88cm for women or ≥102cm for men
- •Index event occurring under chronic low dose of aspirin (<300mg)
- •- Acute coronary syndrome defined as:
- •Acute coronary syndrome with ST-segment elevation (STEMI) is defined as chest pain (≥ 30min) with persistent ST-segment elevation in at least two contiguous leads (≥1mm) or a new left bundle-branch block and the intention to perform primary PCI or thrombolysis.
- •Acute coronary syndrome without ST-segment elevation (NSTEMI) is defined as universal myocardial definition:
- •Detection of cardiac biomarker values elevation [preferably cardiac troponin (cTn)] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following:
- •Symptoms of ischemia
- •New or presumed new significant ST-segment-T wave (ST-T) changes except ST elevation
- •Development of pathological Q waves in the ECG
- •Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
- •Identification of an intracoronary thrombus by angiography
- •included after the angiography showing stenosis ≥50% and before discharge
- •signed informed consent and ≥18 years old
排除标准
- •Allergy or contraindication to aspirin (Hypersensitivity to aspirin or any of the excipients, history of asthma induced by the administration of salicylates, ongoing peptic ulcer, constitutional or acquired haemorrhagic disease including gastrointestinal bleeding, history of hemorrhagic stroke and thrombocytopenia, pregnancy after 24 weeks of gestation, risk of bleeding, severe renal failure, severe hepatic impairment, uncontrolled severe heart failure
- •Concomitant anticoagulation therapy that cannot be stopped
- •Fibrinolytic therapy less than 24 hours.
- •Unstable patients according to investigator: use of amine or mechanical device (IABP, ECMO or similar) or mechanical ventilation during index hospitalization
- •Index event is an acute complication of coronary revascularization (PCI or CABG)
- •Known serious hematological disorder
- •Proven gastric or duodenal ulcer in the past 3 months
- •Previous hemorrhagic stroke, previous cranial bleeding, intracranial neoplasia, arterio-venous malformation
- •Any condition that may put the patient at risk or influence study result in the investigators' opinion (active cancer ….) or that increase the risk for non-compliance or being lost to follow-up
- •Concomitant treatment with methotrexate or with chronic non-steroidal anti-inflammatory drug
- •Pregnancy or lactation or woman of childbearing age without contraception
- •Participant in an another investigational drug study within 30 days
- •Patients under curatorship
- •No social security
研究组 & 干预措施
Arm 2 : Conventional strategy
enteric coated aspirin 100 mg in the morning
干预措施: Conventional strategy Aspirin (Drug)
Arm 1 : Novel strategy
enteric coated aspirin 100 mg in the morning and 100 mg in the evening
干预措施: Novel strategy Aspirin (Drug)
结局指标
主要结局
first main vascular event occurring within the 18 months after randomization among the following: Death (any), Myocardial infarction, Stroke, Urgent coronary revascularization and/or stent thrombosis, Acute arterial thrombotic event
时间窗: at18 months
次要结局
- Net clinical benefit: Death (any), Myocardial infarction, Stroke, Urgent coronary revascularization and/or stent thrombosis, Acute arterial thrombotic event, Major bleeding(at18 months)
- Cardiac endpoint: Cardiovascular death / Myocardial infarction(at18 months)
- Death, myocardial infarction, stroke, urgent revascularization, stent thrombosis, acute arterial thrombotic event and major bleeding analyzed specifically and separately(at18 months)
- Major bleeding (type 3 to 5 following BARC classification(at18 months)