Coronary Artery Ectasia, Efficacy of Various Anti Thrombotic Regimens.

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Efficacy and safety of novel oral anti-coagulants (NOACs) are superior to warfarin in patients with non-valvular atrial fibrillation, By searching the literature, there are few cases of the application of NOACs in coronary ectasia. Rivaroxaban has been showed to reduce ischemic events and cardiovascular mortality along with a higher risk for bleeding in Subjects with Acute Coronary Syndrome (ACS) suggested by the Anti-Xa therapy to lower cardiovascular events in addition to standard therapy in subjects with acute coronary syndrome-thrombolysis in myocardial infarction 51 trial on a background of clopidogrel treatment.

Official Title
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Coronary Artery Ectasia, Thrombotic Background and Efficacy of Various Anti Thrombotic Regimens.

Conditions
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Coronary Artery Ectasia

Intervention / Treatment
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* Drug: Rivaroxaban 2.5 Mg Oral Tablet twice daily
* Drug: Clopidogrel 75 Mg Oral Tablet
* Drug: Aspirin tablet 75 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: acute coronary syndrome group1<br>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. | Drug: Rivaroxaban 2.5 Mg Oral Tablet twice daily<br>* effect of rivaroxaban 2.5 mg twice daily on MACE and quality of life in coronary artery ectasia patients.<br>Drug: Clopidogrel 75 Mg Oral Tablet<br>* Used as control group in 2nd arm and 5th arm<br>|
| Active Comparator: acute coronary syndrome group 2<br>50 patients will be on Aspirin 75mg once daily, clopidogrel 75mg once daily for 1 year. | Drug: Clopidogrel 75 Mg Oral Tablet<br>* Used as control group in 2nd arm and 5th arm<br>Drug: Aspirin tablet 75 mg<br>* Used as control group in 2nd arm and 5th arm<br>|
| Active Comparator: chronic coronary syndrome group 1<br>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 | Drug: Rivaroxaban 2.5 Mg Oral Tablet twice daily<br>* effect of rivaroxaban 2.5 mg twice daily on MACE and quality of life in coronary artery ectasia patients.<br>Drug: Aspirin tablet 75 mg<br>* Used as control group in 2nd arm and 5th arm<br>|
| Active Comparator: chronic coronary syndrome group 2<br>33 patients with clopidogrel 75 mg once daily and Rivaroxaban 2.5mg BID | Drug: Rivaroxaban 2.5 Mg Oral Tablet twice daily<br>* effect of rivaroxaban 2.5 mg twice daily on MACE and quality of life in coronary artery ectasia patients.<br>Drug: Clopidogrel 75 Mg Oral Tablet<br>* Used as control group in 2nd arm and 5th arm<br>|
| Active Comparator: chronic coronary syndrome group 3<br>34 patients with aspirin 75 mg once daily and clopidogrel 75 mg once daily. | Drug: Clopidogrel 75 Mg Oral Tablet<br>* Used as control group in 2nd arm and 5th arm<br>Drug: Aspirin tablet 75 mg<br>* Used as control group in 2nd arm and 5th arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events | Major adverse cardiac events occurence | 1 year | 
| P selectin marker | Correlation of P selectin marker with the severity of the disease. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding risk | Bleeding events occurence | 1 year |