Coronary Artery Ectasia, Efficacy of Various Anti Thrombotic Regimens.

January 30, 2023 updated by: Hamed Mohamed, Assiut University

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

  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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
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
ACTIVE_COMPARATOR: acute coronary syndrome group 2
50 patients will be on Aspirin 75mg once daily, clopidogrel 75mg once daily for 1 year.
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
ACTIVE_COMPARATOR: 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
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: Aspirin tablet 75 mg
Used as control group in 2nd arm and 5th arm
ACTIVE_COMPARATOR: chronic coronary syndrome group 2
33 patients with clopidogrel 75 mg once daily and Rivaroxaban 2.5mg BID
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
ACTIVE_COMPARATOR: chronic coronary syndrome group 3
34 patients with aspirin 75 mg once daily and clopidogrel 75 mg once daily.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac events
Time Frame: 1 year
Major adverse cardiac events occurence
1 year
P selectin marker
Time Frame: 1 year
Correlation of P selectin marker with the severity of the disease.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding risk
Time Frame: 1 year
Bleeding events occurence
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Hamdy S. Mohammad, MD, Assiut University
  • Study Director: Mahmoud A. Abdallah, MD, Assiut University
  • Study Director: Aly M. Tohamy, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2023

Primary Completion (ANTICIPATED)

February 1, 2025

Study Completion (ANTICIPATED)

August 1, 2025

Study Registration Dates

First Submitted

December 3, 2022

First Submitted That Met QC Criteria

January 30, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

January 30, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anti-Thrombotics CAE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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