Coronary Artery Ectasia, Efficacy of Various Anti Thrombotic Regimens.

Status Not yet recruiting

Clinical 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05718531
Study type	Interventional
Source	Assiut University
Contact	Hamed M. Abdelhafez, Master
Phone	+201016604262
Email	hamed.m.h.abdelhafez@gmail.com
Status	Not yet recruiting
Phase	Phase 3
Start date	February 1, 2023
Completion date	August 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05233124` - Antithrombotic Therapy in Acute Coronary Syndromes and Coronary Artery Ectasia	Phase 2
Recruiting	`NCT05713201` - Outcomes After PCI of the Aneurysmatic Right Coronary Artery
Recruiting	`NCT04265989` - A New Classification and Interventional Therapy for Coronary Artery Ectasia	N/A
Recruiting	`NCT00548457` - Endothelial Function in Patients With Ectatic Compared to Normal Coronary Arteries	N/A
Completed	`NCT02024919` - Effect of Diltiazem on Coronary Artery Ectasia	N/A
Not yet recruiting	`NCT05213429` - Jordanian Coronary Artery Ectasia Registry
Completed	`NCT05410678` - Safety And Efficacy Results of Percutaneous Renal Stent Implantation in Ectatic and Aneurysmatic Coronary Arteries	Phase 4
Recruiting	`NCT02831153` - Evaluation of Emotional Status and Coronary Flow Characteristics by TIMI Frame Count Method	N/A
Recruiting	`NCT02818127` - Assessment Of Total Coronary Circulation Time Using TIMI Frame Count Method (TCCT-TIMI)	N/A
Recruiting	`NCT06057987` - Coronary Artery Ectasia Database - Poland
Not yet recruiting	`NCT05692115` - Ischemia and Inflammatory Markers Among Patients With Coronary Artery Ectasia
Recruiting	`NCT05106530` - Arrhythmogenic Risk Assessment in Coronary Artery Ectasia Patients
Completed	`NCT06220682` - Endothelial NO Synthase Polymorphic Gene in Coronary Artery Dilation Disease

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.