NCT05247931Unknown不适用
Why Does Aspirin Fail in Secondary Cerebrovascular Prevention? A Multicenter Prospective Case - Control Study
Fadoi Foundation, Italy16 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年11月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 16
- 主要终点
- To evaluate the rate of recovery of platelet COX-1 activity, measured between 12 and 24 hours after low-dose (100 mg) ASA administration by means of three determinations of serum TXB2 levels, at day 8±1, comparing CASE group vs. CONTROL Group.
研究概览
简要总结
Multicenter prospective observational case-control study aimed at characterizing the possible determinants of treatment failure in patients with cerebrovascular disease on secondary prevention with ASA, who are hospitalized in Internal Medicine departments for a recurrent atherothrombotic stroke.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Age ≥18 years
- •Swallow-test positive
- •Patients hospitalized for a first event of athero-thrombotic stroke (CONTROL group)
- •Patients hospitalized for a recurrence of athero-thrombotic stroke on ASA therapy (CASE group)
- •Informed Consent
排除标准
- •Transient ischemic attack (TIA)
- •Chronic treatment with non-steroidal anti-inflammatory drugs (if occasional, not within 4 days prior to hospitalization)
- •Current treatment with oral or parental anticoagulants at prophylactic or therapeutic doses
- •Current treatment with other antiplatelet agents
- •Thrombolysis and thrombectomy
- •Cardio-embolic stroke CENTRO STUDI FONDAZIONE FADOI Page 10 Studio FADOI.01.2018 Versione n. 2 del 26/09/2019
- •Carotid stenosis >70%, with indication for revascularization
- •Current treatment with ASA (only for patients in the CONTROL group)
- •Acute hepatitis, chronic active hepatitis, liver cirrhosis - or alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher than the upper limit of the normal range
- •Thrombocytopenia (<150000 platelets/μl)
- •Renal failure (eGFR <30 ml/min)
- •Active cancer or disease in complete remission <1 year, except squamous cell carcinoma and basal-cell carcinoma of the skin at initial stage
- •Severe chronic obstructive pulmonary disease (COPD) (oxygen therapy)
- •Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >100 mmHg despite antihypertensive treatment)
- •Chronic inflammatory bowel disease
- •Chronic treatment with corticosteroid drugs (for example Prednisone >5 mg/die or equivalent)
- •Pregnancy (in case of child-bearing potential inclusion will be possible in case of negative pregnancy test)
结局指标
主要结局
To evaluate the rate of recovery of platelet COX-1 activity, measured between 12 and 24 hours after low-dose (100 mg) ASA administration by means of three determinations of serum TXB2 levels, at day 8±1, comparing CASE group vs. CONTROL Group.
时间窗: day 8±1
To evaluate the rate of recovery of platelet COX-1 activity, measured between 12 and 24 hours after low-dose (100 mg) ASA administration by means of three determinations of serum TXB2 levels, at day 8±1, comparing CASE group vs. CONTROL Group.
次要结局
未报告次要终点
研究者
研究点 (16)
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