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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acute coronary syndrome group1 | Active Comparator | 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. |
|
| acute coronary syndrome group 2 | Active Comparator | 50 patients will be on Aspirin 75mg once daily, clopidogrel 75mg once daily for 1 year. |
|
| chronic coronary syndrome group 1 | Active Comparator | 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 |
|
| chronic coronary syndrome group 2 | Active Comparator | 33 patients with clopidogrel 75 mg once daily and Rivaroxaban 2.5mg BID |
|
| chronic coronary syndrome group 3 | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban 2.5 Mg Oral Tablet twice daily | Drug | effect of rivaroxaban 2.5 mg twice daily on MACE and quality of life in coronary artery ectasia patients. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding risk | Bleeding events occurence | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hamed M. Abdelhafez, Master | Contact | +201016604262 | hamed.m.h.abdelhafez@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hamdy S. Mohammad, MD | Assiut University | Study Chair |
| Mahmoud A. Abdallah, MD | Assiut University | Study Director |
| Aly M. Tohamy, MD |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17492685 | Background | Ramappa P, Kottam A, Kuivanemi H, Thatai D. Coronary artery ectasia--is it time for a reappraisal? Clin Cardiol. 2007 May;30(5):214-7. doi: 10.1002/clc.20002. | |
| 29051141 | Background | Doi T, Kataoka Y, Noguchi T, Shibata T, Nakashima T, Kawakami S, Nakao K, Fujino M, Nagai T, Kanaya T, Tahara Y, Asaumi Y, Tsuda E, Nakai M, Nishimura K, Anzai T, Kusano K, Shimokawa H, Goto Y, Yasuda S. Coronary Artery Ectasia Predicts Future Cardiac Events in Patients With Acute Myocardial Infarction. Arterioscler Thromb Vasc Biol. 2017 Dec;37(12):2350-2355. doi: 10.1161/ATVBAHA.117.309683. Epub 2017 Oct 19. |
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| ID | Term |
|---|---|
| D003323 | Coronary Aneurysm |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D000077144 | Clopidogrel |
| D013607 | Tablets |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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34 patients with aspirin 75 mg once daily and clopidogrel 75 mg once daily.
|
| Clopidogrel 75 Mg Oral Tablet | Drug | Used as control group in 2nd arm and 5th arm |
|
| Aspirin tablet 75 mg | Drug | Used as control group in 2nd arm and 5th arm |
|
| Assiut University |
| Study Director |
| 34660041 | Background | Khedr A, Neupane B, Proskuriakova E, Jada K, Kakieu Djossi S, Mostafa JA. Pharmacologic Management of Coronary Artery Ectasia. Cureus. 2021 Sep 8;13(9):e17832. doi: 10.7759/cureus.17832. eCollection 2021 Sep. |
| 31787821 | Background | Pranata R, Yonas E, Chintya V, Alkatiri AA. Is Anticoagulant Necessary in Patients with Coronary Artery Ectasia Presenting with Acute Coronary Syndrome? A Systematic Review of Case Reports. Int J Angiol. 2019 Dec;28(4):231-236. doi: 10.1055/s-0039-1692706. Epub 2019 Jun 28. |
| 22822179 | Background | Oldridge N, Hofer S, McGee H, Conroy R, Doyle F, Saner H; (for the HeartQoL Project Investigators). The HeartQoL: Part I. Development of a new core health-related quality of life questionnaire for patients with ischemic heart disease. Eur J Prev Cardiol. 2014 Jan;21(1):90-7. doi: 10.1177/2047487312450544. Epub 2012 Jul 20. |
| 22822180 | Background | Oldridge N, Hofer S, McGee H, Conroy R, Doyle F, Saner H; (for the HeartQoL Project Investigators). The HeartQoL: part II. Validation of a new core health-related quality of life questionnaire for patients with ischemic heart disease. Eur J Prev Cardiol. 2014 Jan;21(1):98-106. doi: 10.1177/2047487312450545. Epub 2012 Jul 20. |
| D000783 |
| Aneurysm |
| D014652 | Vascular Diseases |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D011725 | Pyridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |