NCT05718531

Coronary Artery Ectasia, Efficacy of Various Anti Thrombotic Regimens.

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Artery Ectasia

Interventions

Type	Name	Description
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.
DRUG	Clopidogrel 75 Mg Oral Tablet	Used as control group in 2nd arm and 5th arm
DRUG	Aspirin tablet 75 mg	Used as control group in 2nd arm and 5th arm

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-02-01
• Completion: 2025-08-01
• First posted: 2023-02-08
• Last updated: 2023-02-08