Lead Investigator: Michele Romoli, Bufalini Hospital
Title of Proposal Research: Antithrombotics in patent formane ovale (PFO)-related stroke: a meta-analysis stratified for the risk of paradoxical embolism score (RoPE)
Vivli Data Request: 7379
Funding Source: None
Potential Conflicts of Interest: Dr. Zini took part and is listed among authors of the RESPECT-ESUS trial; he is currently the Principal Investigator of the FibER trial (fibrinogen repletion after thrombolysis) and is currently investigator for the PACIFIC stroke, AXIOMATIC stroke, ANNEXXA-III/IV trials.
The aim of this project is to meta-analyze data on stroke recurrence depending on treatment arm, stratified by risk of paradoxical embolism score (RoPE). There is no conflict of interest in regard to the aim of this project.
Summary of the Proposed Research:
Project overview
Patent foramen ovale (PFO) is a small opening between the 2 upper chambers of the heart, the right and the left atrium, and it can be a risk factor for stroke caused by restricted blood flow to the brain. Since blood clot is presumed to be the mechanism with which patent foramen ovale induces stroke, medications to prevent blood clots (anticoagulants) might be beneficial. Recent studies, comparing anticoagulants versus treatments to prevent blood platelet clots (antiplatelets), have been unable to demonstrate superiority of the former vs the latter. Nevertheless, people enrolled could have risk factors for stroke other than patent foramen ovale. Therefore, these factors might have limited the effectiveness of anticoagulation. We aim to perform a meta-analysis based on the risk of paradoxical embolism (RoPE) score, a tool that allows you to calculate if the stroke is attributable to patent foramen ovale or to other factors. We presume that, the higher the attributable risk, the more anticoagulation is worthwhile. We have already shown, in a previous meta-analysis that a trend exists confirming our hypothesis, and we would investigate this in more detail to provide direct implications to clinical practice.
Requested Studies:
Randomized, Double-blind, Evaluation in Secondary Stroke Prevention Comparing the EfficaCy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate (110 mg or 150 mg, Oral b.i.d.) Versus Acetylsalicylic Acid (100 mg Oral q.d.) in Patients With Embolic Stroke of Undetermined Source (RESPECT ESUS)
Data Contributor: Boehringer Ingelheim
Study ID: NCT02239120
Sponsor ID: 1160.189
Update: This data request was withdrawn on 17-Apr-2023 by the researcher.