A Phase 3 interventional study of Rivaroxaban 2.5 Mg Oral Tablet twice daily and Clopidogrel 75 Mg Oral Tablet in Coronary Artery Ectasia, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Assiut University · Phase 3, Interventional, and Treatment
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:
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.
31 studies on the registry are indexed under Coronary Aneurysm; 10 are open to participants now.
This study's planned enrollment of 200 is above the median of 82 across 16 interventional studies indexed under Coronary Aneurysm.
Browse Coronary Aneurysm studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
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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 · Drug: Clopidogrel 75 Mg Oral Tablet
50 patients will be on Aspirin 75mg once daily, clopidogrel 75mg once daily for 1 year.
Drug: Clopidogrel 75 Mg Oral Tablet · Drug: Aspirin tablet 75 mg
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 · Drug: Aspirin tablet 75 mg
33 patients with clopidogrel 75 mg once daily and Rivaroxaban 2.5mg BID
Drug: Rivaroxaban 2.5 Mg Oral Tablet twice daily · Drug: Clopidogrel 75 Mg Oral Tablet
34 patients with aspirin 75 mg once daily and clopidogrel 75 mg once daily.
Drug: Clopidogrel 75 Mg Oral Tablet · Drug: Aspirin tablet 75 mg
effect of rivaroxaban 2.5 mg twice daily on MACE and quality of life in coronary artery ectasia patients.
Used as control group in 2nd arm and 5th arm
Used as control group in 2nd arm and 5th arm
Major adverse cardiac events
Major adverse cardiac events occurence
Time frame: 1 year
P selectin marker
Correlation of P selectin marker with the severity of the disease.
Time frame: 1 year
Bleeding risk
Bleeding events occurence
Time frame: 1 year
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol, Clinical study report
Start is estimated for Feb 2023; primary completion for Feb 2025, 24 months later.
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This study is not yet recruiting, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Rivaroxaban · Clopidogrel · Aspirin