NCT05068414Completed
Assessment of the Incidence of Hemorrhagic and Ischemic Events in Post-angioplasty in Anticoagulated Coronary Patients with Atrial Fibrillation
Evaluation De L'incidence Des Évènements Hémorragiques Et Ischémiques En Post-angioplastie Chez Des Patients Coronariens Anticoagulés Dans Le Cadre D'une Fibrillation Auriculaire
Source: ClinicalTrials.gov · Last updated 13 Feb 2025
Brief summary (registry, in English)
Atrial fibrillation (AF) is a supraventricular arrhythmia characterized by uncoordinated and fast atrial activity, and coronary artery disease (chronic and acute coronary syndrome) is characterized by a generally atheromatous narrowing of the coronary arteries. Angioplasty is necessary to restore arterial circulation in coronary artery disease. A dual anti-aggregating therapy is then initiated in these patients in parallel with treatment of AF with anticoagulation. This triple therapy exposes the patient to an increased risk of hemorrhage. The combination of oral anticoagulation with antiplatelet inhibitor in long-term anticoagulated patients requiring stent placement has been studied in several recent trials (e.g. WOEST, PIONEER AF PCI, REDUAL PCI and AUGUSTUS). The results of these studies have formed the basis of the European recommendations of 2017 and 2020, whereby the therapeutic strategy depends on the risk of hemorrhage or ischemia. However, the hemorrhagic risk assessment factors included in the scores overlap with those for ischemic risk. It is therefore difficult to determine the predominant risk for each patient. Thus, uncertainties persist as to the optimal duration of a triple therapy and the optimal recommended dose. In this study, the investigators aim to establish an inventory of the current practices by evaluating the incidence of hemorrhagic and ischemic events in post-angioplasty in anticoagulated coronary patients in the context of atrial fibrillation.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 122 (actual)
- First submitted
- 27 Sept 2021
- Start date
- 12 Apr 2021
- Primary completion date
- 11 Oct 2023
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- NCT number
- NCT05068414
What you commit to
- Study type: Observational
- Participants enrolled: 122
- From 12 Apr 2021 to the primary completion date, 11 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The subject is in a period of exclusion determined by a previous study
Other
- The patient has already been included into this study
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient pregnant, parturient or breast feeding
Who the study is looking for
- Patient on anti-coagulating therapy before or during hospitalization for atrial fibrillation
- Patient hospitalized in the cardiology ward admitted for acute or chronic coronary syndrome requiring coronary angioplasty
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Nîmes Coordinator of this site? Confirm its status | Nîmes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.