Coronary Artery Ectasia, Thrombotic Background and Efficacy of Various Anti Thrombotic Regimens.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Major adverse cardiac events
研究概览
简要总结
- To evaluate short and intermediate clinical outcome of different anti-thrombotic regimens on major adverse cardiac events (MACE) and quality of life in coronary artery ectasia patients.
- To evaluate role of P-selectin as a marker of cardiovascular risk in coronary artery ectasia.
详细描述
Coronary artery ectasia (CAE) is the diffuse dilatation of coronary artery. It is defined as a dilatation with a diameter of 1.5 times the adjacent normal coronary artery . Its prevalence ranges from 1.2%-4.9% with male to female ratio of 3:1.
CAE is more common in males. Hypertension is a risk Factor. Interestingly, patients with Diabetes Mellitus (DM) have low incidence of CAE. This may be due to down regulation of matrix metalloproteinase (MMP) with negative re-modelling in response to atherosclerosis. Smoking appears to be more common in patients with CAE than in those with coronary artery disease (CAD).
Treatment for CAE is a controversial topic, as there is lack of clinical trials and standardized guidelines, Current options include:
- aggressive risk-factor modification
- Management of the coronary artery disease if obstructive lesions are found. Anti-platelet therapy with aspirin has been suggested for all CAE patients since most have coexistent coronary artery obstructive lesions and high likelihood of developing a myocardial infarction (MI). There have not been any prospective random studies evaluating the role of adenosine diphosphate inhibitors as part of therapy.
Considering anticoagulation therapy to prevent coronary thrombus formation has been a debatable topic due to limited randomized trials.it was strongly suggested to use warfarin as the basic treatment for achieving long-term anticoagulation in one study.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients diagnosed with coronary artery ectasia either associated with obstructive or non-obstructive coronary artery disease after undergoing coronary angiography at cath. lab, cardiology department, Assiut university heart hospital, Assiut university.
排除标准
- •Atrial fibrillation
- •Left ventricular thrombus
- •severe Valvular heart disease.
- •Mechanical valve prothesis
- •Crusade score ≥ 41 (high - very high risk)
- •deep venous thrombosis, pulmonary embolism
- •renal failure stage IV-V.
- •known malignancy
- •Evidence of acute or chronic infection (by history or clinical examination).
- •History of systemic inflammatory or autoimmune disease.
- •History of any clinically significant endocrine, hematologic, respiratory, or metabolic diseases
研究组 & 干预措施
acute coronary syndrome group1
50 patients will have triple therapy (Aspirin,75 mg once daily, clopidogrel 75 mg once daily, and Rivaroxaban 2.5mg BID) prescribed for 3 month, then clopidogrel and Rivaroxaban for the following 9 months.
干预措施: Rivaroxaban 2.5 Mg Oral Tablet twice daily (Drug)
acute coronary syndrome group1
50 patients will have triple therapy (Aspirin,75 mg once daily, clopidogrel 75 mg once daily, and Rivaroxaban 2.5mg BID) prescribed for 3 month, then clopidogrel and Rivaroxaban for the following 9 months.
干预措施: Clopidogrel 75 Mg Oral Tablet (Drug)
acute coronary syndrome group 2
50 patients will be on Aspirin 75mg once daily, clopidogrel 75mg once daily for 1 year.
干预措施: Clopidogrel 75 Mg Oral Tablet (Drug)
acute coronary syndrome group 2
50 patients will be on Aspirin 75mg once daily, clopidogrel 75mg once daily for 1 year.
干预措施: Aspirin tablet 75 mg (Drug)
chronic coronary syndrome group 1
33 patients with prescribed aspirin 75 mg once daily and Rivaroxaban 2.5 mg BID N.B: Patients with stents placement within a year will be excluded from this group
干预措施: Rivaroxaban 2.5 Mg Oral Tablet twice daily (Drug)
chronic coronary syndrome group 1
33 patients with prescribed aspirin 75 mg once daily and Rivaroxaban 2.5 mg BID N.B: Patients with stents placement within a year will be excluded from this group
干预措施: Aspirin tablet 75 mg (Drug)
chronic coronary syndrome group 2
33 patients with clopidogrel 75 mg once daily and Rivaroxaban 2.5mg BID
干预措施: Rivaroxaban 2.5 Mg Oral Tablet twice daily (Drug)
chronic coronary syndrome group 2
33 patients with clopidogrel 75 mg once daily and Rivaroxaban 2.5mg BID
干预措施: Clopidogrel 75 Mg Oral Tablet (Drug)
chronic coronary syndrome group 3
34 patients with aspirin 75 mg once daily and clopidogrel 75 mg once daily.
干预措施: Clopidogrel 75 Mg Oral Tablet (Drug)
chronic coronary syndrome group 3
34 patients with aspirin 75 mg once daily and clopidogrel 75 mg once daily.
干预措施: Aspirin tablet 75 mg (Drug)
结局指标
主要结局
Major adverse cardiac events
时间窗: 1 year
Major adverse cardiac events occurence
P selectin marker
时间窗: 1 year
Correlation of P selectin marker with the severity of the disease.
次要结局
- Bleeding risk(1 year)
研究者
Hamed Mohamed
Cardiology Specialist
Assiut University