Coronary Artery Ectasia, Efficacy of Various Anti Thrombotic Regimens.

Coronary Artery Ectasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05718531
• Other study ID #: Anti-Thrombotics CAE
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 1, 2023
• Est. completion date: August 2025

Study information

• Verified date: January 2023
• Source: Assiut University
• Contact: Hamed M. Abdelhafez, Master
• Phone: +201016604262
• Email: hamed.m.h.abdelhafez[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

1. 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.

2. To evaluate role of P-selectin as a marker of cardiovascular risk in coronary artery ectasia.

Description:

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:

1. aggressive risk-factor modification

2. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

1. Atrial fibrillation

2. Left ventricular thrombus

3. severe Valvular heart disease.

4. Mechanical valve prothesis

5. Crusade score = 41 (high - very high risk)

6. deep venous thrombosis, pulmonary embolism

7. renal failure stage IV-V.

8. known malignancy

9. Evidence of acute or chronic infection (by history or clinical examination).

10. History of systemic inflammatory or autoimmune disease.

11. History of any clinically significant endocrine, hematologic, respiratory, or metabolic diseases

Related Conditions & MeSH terms

• Coronary Aneurysm
• Coronary Artery Ectasia

Intervention

Drug:
• Rivaroxaban 2.5 Mg Oral Tablet twice daily
effect of rivaroxaban 2.5 mg twice daily on MACE and quality of life in coronary artery ectasia patients.
• Clopidogrel 75 Mg Oral Tablet
Used as control group in 2nd arm and 5th arm
• Aspirin tablet 75 mg
Used as control group in 2nd arm and 5th arm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events	Major adverse cardiac events occurence	1 year
Primary	P selectin marker	Correlation of P selectin marker with the severity of the disease.	1 year
Secondary	Bleeding risk	Bleeding events occurence	1 year