NCT05718531

Brief Summary

  1. 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. 2.To evaluate role of P-selectin as a marker of cardiovascular risk in coronary artery ectasia.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

February 8, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

December 3, 2022

Last Update Submit

January 30, 2023

Conditions

Coronary Artery Ectasia

Outcome Measures

Primary Outcomes (2)

  • Major adverse cardiac events

    Major adverse cardiac events occurence

    1 year

  • P selectin marker

    Correlation of P selectin marker with the severity of the disease.

    1 year

Secondary Outcomes (1)

  • Bleeding risk

    1 year

Study Arms (5)

acute coronary syndrome group1

ACTIVE COMPARATOR

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 dailyDrug: Clopidogrel 75 Mg Oral Tablet

acute coronary syndrome group 2

ACTIVE COMPARATOR

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

Drug: Clopidogrel 75 Mg Oral TabletDrug: Aspirin tablet 75 mg

chronic coronary syndrome group 1

ACTIVE COMPARATOR

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 dailyDrug: Aspirin tablet 75 mg

chronic coronary syndrome group 2

ACTIVE COMPARATOR

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

Drug: Rivaroxaban 2.5 Mg Oral Tablet twice dailyDrug: Clopidogrel 75 Mg Oral Tablet

chronic coronary syndrome group 3

ACTIVE COMPARATOR

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

Drug: Clopidogrel 75 Mg Oral TabletDrug: Aspirin tablet 75 mg

Interventions

Rivaroxaban 2.5 Mg Oral Tablet twice dailyDRUG

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

acute coronary syndrome group1chronic coronary syndrome group 1chronic coronary syndrome group 2
Clopidogrel 75 Mg Oral TabletDRUG

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

acute coronary syndrome group 2acute coronary syndrome group1chronic coronary syndrome group 2chronic coronary syndrome group 3
Aspirin tablet 75 mgDRUG

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

acute coronary syndrome group 2chronic coronary syndrome group 1chronic coronary syndrome group 3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 17492685BACKGROUND

  • 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.

    PMID: 29051141BACKGROUND

  • 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.

    PMID: 34660041BACKGROUND

  • 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.

    PMID: 31787821BACKGROUND

  • 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.

    PMID: 22822179BACKGROUND

  • 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.

    PMID: 22822180BACKGROUND

MeSH Terms

Conditions

Coronary Aneurysm

Interventions

RivaroxabanClopidogrelTabletsAspirin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesAneurysmVascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTiclopidineThienopyridinesPyridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDosage FormsPharmaceutical PreparationsSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Hamdy S. Mohammad, MD

    Assiut University

    STUDY CHAIR

  • Mahmoud A. Abdallah, MD

    Assiut University

    STUDY DIRECTOR

  • Aly M. Tohamy, MD

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Hamed M. Abdelhafez, Master

CONTACT

+201016604262hamed.m.h.abdelhafez@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiology Specialist

Study Record Dates

First Submitted

December 3, 2022

First Posted

February 8, 2023

Study Start

February 1, 2023

Primary Completion

February 1, 2025

Study Completion

August 1, 2025

Last Updated

February 8, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, CSR