Coronary Artery EctasiaPhase 3NCT05718531
Coronary Artery Ectasia, Efficacy of Various Anti Thrombotic Regimens.
A Phase 3 study testing Rivaroxaban 2.5 Mg Oral Tablet twice daily, Clopidogrel 75 Mg Oral Tablet and Aspirin tablet 75 mg in people with Coronary Artery Ectasia, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Ectasia
- What is being tested?
- Rivaroxaban 2.5 Mg Oral Tablet twice daily, Clopidogrel 75 Mg Oral Tablet and Aspirin tablet 75 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Atrial fibrillation
- Left ventricular thrombus
- severe Valvular heart disease.
- Mechanical valve prothesis
- Crusade score ≥ 41 (high - very high risk)
- deep venous thrombosis, pulmonary embolism
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Coronary Artery Ectasia, Thrombotic Background and Efficacy of Various Anti Thrombotic Regimens.
- 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.
Read the 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.
- Conditions
- Coronary Artery Ectasia
- Being tested
- Rivaroxaban 2.5 Mg Oral Tablet twice daily, Clopidogrel 75 Mg Oral Tablet, Aspirin tablet 75 mg
- Medical subject headings
- Coronary Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Clopidogrel 75 Mg Oral TabletDrug
Used as control group in 2nd arm and 5th arm
Aspirin tablet 75 mgDrug
Used as control group in 2nd arm and 5th arm
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Rivaroxaban 2.5 Mg Oral Tablet twice daily; Drug: 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. Receives: Drug: Clopidogrel 75 Mg Oral Tablet; Drug: 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 Receives: Drug: Rivaroxaban 2.5 Mg Oral Tablet twice daily; Drug: Aspirin tablet 75 mg |
| chronic coronary syndrome group 2 | Active comparator | 33 patients with clopidogrel 75 mg once daily and Rivaroxaban 2.5mg BID Receives: Drug: Rivaroxaban 2.5 Mg Oral Tablet twice daily; Drug: 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. Receives: Drug: Clopidogrel 75 Mg Oral Tablet; Drug: Aspirin tablet 75 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
Major adverse cardiac events occurence
Measured: 1 year
P selectin marker
Correlation of P selectin marker with the severity of the disease.
Measured: 1 year
Secondary outcomes (1)
Bleeding risk
Bleeding events occurence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Feb 2023 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery EctasiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamed Mohamed, Assiut University
- Investigators
- Hamdy S. Mohammad, MD, Study chair, Assiut UniversityMahmoud A. Abdallah, MD, Study director, Assiut UniversityAly M. Tohamy, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718531
- Sponsor's protocol ID
- Anti-Thrombotics CAE
- Status last verified
- Jan 2023
- First submitted
- 3 Dec 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 17492685Doi 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.
PubMed 29051141Khedr 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.
PubMed 34660041Pranata 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.
PubMed 31787821Oldridge 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.
PubMed 22822179Oldridge 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.
PubMed 22822180
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Ectasia, Thrombotic Background and Efficacy of Various Anti Thrombotic Regimens.
- ClinicalTrials.gov ID
- NCT05718531
- Acronym / sponsor ID
- Anti-Thrombotics CAE
- Conditions
- Coronary Artery Ectasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| acute coronary syndrome group1 | Active comparator | Drug: Rivaroxaban 2.5 Mg Oral Tablet twice daily, Drug: Clopidogrel 75 Mg Oral Tablet50 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. |
| acute coronary syndrome group 2 | Active comparator | Drug: Clopidogrel 75 Mg Oral Tablet, Drug: Aspirin tablet 75 mg50 patients will be on Aspirin 75mg once daily, clopidogrel 75mg once daily for 1 year. |
| chronic coronary syndrome group 1 | Active comparator | Drug: Rivaroxaban 2.5 Mg Oral Tablet twice daily, Drug: Aspirin tablet 75 mg33 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 |
| chronic coronary syndrome group 2 | Active comparator | Drug: Rivaroxaban 2.5 Mg Oral Tablet twice daily, Drug: Clopidogrel 75 Mg Oral Tablet33 patients with clopidogrel 75 mg once daily and Rivaroxaban 2.5mg BID |
| chronic coronary syndrome group 3 | Active comparator | Drug: Clopidogrel 75 Mg Oral Tablet, Drug: Aspirin tablet 75 mg34 patients with aspirin 75 mg once daily and clopidogrel 75 mg once daily. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- Atrial fibrillation
- Left ventricular thrombus
- severe Valvular heart disease.
- Mechanical valve prothesis
- Crusade score ≥ 41 (high - very high risk)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban 2.5 Mg Oral Tablet twice dailyeffect of rivaroxaban 2.5 mg twice daily on MACE and quality of life in coronary artery ectasia patients. | Drug | acute coronary syndrome group1, chronic coronary syndrome group 1, chronic coronary syndrome group 2 |
| Clopidogrel 75 Mg Oral TabletUsed as control group in 2nd arm and 5th arm | Drug | acute coronary syndrome group 2, acute coronary syndrome group1, chronic coronary syndrome group 2, chronic coronary syndrome group 3 |
| Aspirin tablet 75 mgUsed as control group in 2nd arm and 5th arm | Drug | acute coronary syndrome group 2, chronic coronary syndrome group 1, chronic coronary syndrome group 3 |
Primary outcome
Major adverse cardiac events
Time frame: 1 year
Major adverse cardiac events occurence
P selectin marker
Time frame: 1 year
Correlation of P selectin marker with the severity of the disease.
1 secondary outcome
Bleeding risk
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 17492685Ramappa 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.
- Background: PubMed 29051141Doi 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.
- Background: PubMed 34660041Khedr 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.
- Background: PubMed 31787821Pranata 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.
- Background: PubMed 22822179Oldridge 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.
- Background: PubMed 22822180Oldridge 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamdy S. Mohammad, MD study chair
Assiut University
Mahmoud A. Abdallah, MD study director
Assiut University
Aly M. Tohamy, MD study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivaroxaban 2.5 Mg Oral Tablet twice daily, Clopidogrel 75 Mg Oral Tablet and Aspirin tablet 75 mg in people with Coronary Artery Ectasia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hamed M. Abdelhafez, Master (+201016604262, hamed.m.h.abdelhafez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05718531, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.