Antithrombotic Strategy Variability In ATrial Fibrillation and Obstructive Coronary Disease Revascularized With PCI

Status: Completed
Location: See location...
Study Type: Observational
SUMMARY

The purpose of this observational registry was to compare the safety and efficacy of an antithrombotic regimen comprising one single antiplatelet agent plus an oral anti-thrombotic versus those consisting of DAPT alone or DAPT plus oral antithrombotic therapy. This registry assessed whether the antithrombotic therapy intensity would vary positively with physician perceived ischemic risk at the time of percutaneous coronary intervention (PCI), and whether an inverse association would be observed with perceived bleeding risk. This study also evaluated the physician use of objective benefit-risk assessment scores and their influence on prescription of antithrombotic therapy in atrial fibrillation (AF) patients undergoing PCI. Additionally the study investigated whether patient perceived relevance and accessibility of anti-platelet and anticoagulant treatment regiments would predict treatment adherence and whether non-adherence would independently influence outcome. Approximately 514 subjects with non-valvular AF undergoing all-comer PCI were enrolled at 11 sites in North America and Europe. Follow-up was done via telephone by trained research coordinators at each participating site at 30 days, 6 months and 12 months.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of non-valvular atrial fibrillation during hospitalization.

• Preexisting atrial fibrillation.

• Successful all-comer percutaneous coronary intervention:

⁃ Procedural success is defined as a reduction of residual luminal diameter stenosis to \<50% without in-hospital death, AMI or the need for emergency CABG.

• Over 18 years of age

• Able to provide written informed consent

Locations
United States
New York
Icahn School of Medicine at Mount Sinai
New York
Time Frame
Start Date: 2015-04
Completion Date: 2018-11-15
Participants
Target number of participants: 514
Treatments
Antiplatelet agent plus anticoagulant
an antithrombotic regimen comprising one single antiplatelet agent plus an anticoagulant
DAPT alone
an antithrombotic regimen consisting of dual antiplatelet therapy (DAPT) alone
DAPT plus anticoagulant
an antithrombotic regimen consisting of DAPT plus anticoagulant therapy
Sponsors
Collaborators: Bristol-Myers Squibb
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov

Similar Clinical Trials