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Coronary Artery Ectasia, Efficacy of Various Anti Thrombotic Regimens.

Primary Purpose

Coronary Artery Ectasia

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rivaroxaban 2.5 Mg Oral Tablet twice daily
Clopidogrel 75 Mg Oral Tablet
Aspirin tablet 75 mg
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Ectasia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: Atrial fibrillation Left ventricular thrombus severe Valvular heart disease. Mechanical valve prothesis Crusade score ≥ 41 (high - very high risk) deep venous thrombosis, pulmonary embolism renal failure stage IV-V. known malignancy Evidence of acute or chronic infection (by history or clinical examination). History of systemic inflammatory or autoimmune disease. History of any clinically significant endocrine, hematologic, respiratory, or metabolic diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    acute coronary syndrome group1

    acute coronary syndrome group 2

    chronic coronary syndrome group 1

    chronic coronary syndrome group 2

    chronic coronary syndrome group 3

    Arm Description

    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.

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

    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

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

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

    Outcomes

    Primary Outcome Measures

    Major adverse cardiac events
    Major adverse cardiac events occurence
    P selectin marker
    Correlation of P selectin marker with the severity of the disease.

    Secondary Outcome Measures

    Bleeding risk
    Bleeding events occurence

    Full Information

    First Posted
    December 3, 2022
    Last Updated
    January 30, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05718531
    Brief Title
    Coronary Artery Ectasia, Efficacy of Various Anti Thrombotic Regimens.
    Official Title
    Coronary Artery Ectasia, Thrombotic Background and Efficacy of Various Anti Thrombotic Regimens.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    February 2025 (Anticipated)
    Study Completion Date
    August 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    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. 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: aggressive risk-factor modification 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Ectasia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    acute coronary syndrome group1
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    acute coronary syndrome group 2
    Arm Type
    Active Comparator
    Arm Description
    50 patients will be on Aspirin 75mg once daily, clopidogrel 75mg once daily for 1 year.
    Arm Title
    chronic coronary syndrome group 1
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    chronic coronary syndrome group 2
    Arm Type
    Active Comparator
    Arm Description
    33 patients with clopidogrel 75 mg once daily and Rivaroxaban 2.5mg BID
    Arm Title
    chronic coronary syndrome group 3
    Arm Type
    Active Comparator
    Arm Description
    34 patients with aspirin 75 mg once daily and clopidogrel 75 mg once daily.
    Intervention Type
    Drug
    Intervention Name(s)
    Rivaroxaban 2.5 Mg Oral Tablet twice daily
    Intervention Description
    effect of rivaroxaban 2.5 mg twice daily on MACE and quality of life in coronary artery ectasia patients.
    Intervention Type
    Drug
    Intervention Name(s)
    Clopidogrel 75 Mg Oral Tablet
    Intervention Description
    Used as control group in 2nd arm and 5th arm
    Intervention Type
    Drug
    Intervention Name(s)
    Aspirin tablet 75 mg
    Intervention Description
    Used as control group in 2nd arm and 5th arm
    Primary Outcome Measure Information:
    Title
    Major adverse cardiac events
    Description
    Major adverse cardiac events occurence
    Time Frame
    1 year
    Title
    P selectin marker
    Description
    Correlation of P selectin marker with the severity of the disease.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Bleeding risk
    Description
    Bleeding events occurence
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: Atrial fibrillation Left ventricular thrombus severe Valvular heart disease. Mechanical valve prothesis Crusade score ≥ 41 (high - very high risk) deep venous thrombosis, pulmonary embolism renal failure stage IV-V. known malignancy Evidence of acute or chronic infection (by history or clinical examination). History of systemic inflammatory or autoimmune disease. History of any clinically significant endocrine, hematologic, respiratory, or metabolic diseases
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hamed M. Abdelhafez, Master
    Phone
    +201016604262
    Email
    hamed.m.h.abdelhafez@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hamdy S. Mohammad, MD
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Mahmoud A. Abdallah, MD
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Aly M. Tohamy, MD
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    17492685
    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.
    Results Reference
    background
    PubMed Identifier
    29051141
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    34660041
    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.
    Results Reference
    background
    PubMed Identifier
    31787821
    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.
    Results Reference
    background
    PubMed Identifier
    22822179
    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.
    Results Reference
    background
    PubMed Identifier
    22822180
    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.
    Results Reference
    background

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    Coronary Artery Ectasia, Efficacy of Various Anti Thrombotic Regimens.

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