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Coronary Artery Ectasia, Efficacy of Various Anti Thrombotic Regimens.

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05718531
Enrollment
200
Registered
2023-02-08
Start date
2023-02-01
Completion date
2025-08-31
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Ectasia

Brief 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.

Interventions

DRUGRivaroxaban 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.

Used as control group in 2nd arm and 5th arm

DRUGAspirin tablet 75 mg

Used as control group in 2nd arm and 5th arm

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Major adverse cardiac events1 yearMajor adverse cardiac events occurence
P selectin marker1 yearCorrelation of P selectin marker with the severity of the disease.

Secondary

MeasureTime frameDescription
Bleeding risk1 yearBleeding events occurence

Contacts

Primary ContactHamed M. Abdelhafez, Master
hamed.m.h.abdelhafez@gmail.com+201016604262

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026