Coronary Artery Ectasia, Efficacy of Various Anti Thrombotic Regimens.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-08-31

Brief Summary

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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.

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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:

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

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Coronary Artery Ectasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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acute coronary syndrome group1

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.

Group Type ACTIVE_COMPARATOR

Rivaroxaban 2.5 Mg Oral Tablet twice daily

Intervention Type DRUG

effect of rivaroxaban 2.5 mg twice daily on MACE and quality of life in coronary artery ectasia patients.

Clopidogrel 75 Mg Oral Tablet

Intervention Type DRUG

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

acute coronary syndrome group 2

50 patients will be on Aspirin 75mg once daily, clopidogrel 75mg once daily for 1 year.

Group Type ACTIVE_COMPARATOR

Clopidogrel 75 Mg Oral Tablet

Intervention Type DRUG

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

Aspirin tablet 75 mg

Intervention Type DRUG

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

chronic coronary syndrome group 1

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

Group Type ACTIVE_COMPARATOR

Rivaroxaban 2.5 Mg Oral Tablet twice daily

Intervention Type DRUG

effect of rivaroxaban 2.5 mg twice daily on MACE and quality of life in coronary artery ectasia patients.

Aspirin tablet 75 mg

Intervention Type DRUG

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

chronic coronary syndrome group 2

33 patients with clopidogrel 75 mg once daily and Rivaroxaban 2.5mg BID

Group Type ACTIVE_COMPARATOR

Rivaroxaban 2.5 Mg Oral Tablet twice daily

Intervention Type DRUG

effect of rivaroxaban 2.5 mg twice daily on MACE and quality of life in coronary artery ectasia patients.

Clopidogrel 75 Mg Oral Tablet

Intervention Type DRUG

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

chronic coronary syndrome group 3

34 patients with aspirin 75 mg once daily and clopidogrel 75 mg once daily.

Group Type ACTIVE_COMPARATOR

Clopidogrel 75 Mg Oral Tablet

Intervention Type DRUG

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

Aspirin tablet 75 mg

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Clopidogrel 75 Mg Oral Tablet

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

Intervention Type DRUG

Aspirin tablet 75 mg

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

Intervention Type DRUG

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No