Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk Patients
INTERMITTENT
Safety and Efficacy of Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk (HBR) Patients With History of Paroxysmal Atrial Fibrillation
1 other identifier
observational
100
1 country
2
Brief Summary
Preliminary experiences suggest that intermittent anticoagulation guided by continuous electrocardiographic monitoring can reduce the incidence of bleeding in patients with episodes of atrial fibrillation. Uncertainty about the potential implications of a strategy of intermittent anticoagulation after percutaneous coronary intervention exists. The investigators will perform a case-control study to evaluate the safety and efficacy of anticoagulation on demand in high bleeding risk (HBR) patients with paroxysmal atrial fibrillation after percutaneous coronary intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2019
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2019
CompletedFirst Posted
Study publicly available on registry
November 5, 2019
CompletedStudy Start
First participant enrolled
December 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedSeptember 9, 2022
September 1, 2022
3 years
October 30, 2019
September 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Major Adverse Outcome Event (MACE)
The time to final occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia driven revascularization
Up to 1 year
Days on anticoagulant treatment
The total number of days on anticoagulant treatment
Up to 1 year
Study Arms (2)
Intermittent anticoagulation
Patients receiving anticoagulation only if continuous electrocardiographic monitoring detects an atrial fibrillation episode
Chronic anticoagulation
Patients receiving chronic oral anticoagulation regardless findings at continuous electrocardiographic monitoring
Interventions
Patients will receive intermittent treatment with a novel oral anticoagulant drug
Patients will receive chronic treatment with a novel oral anticoagulant drug
Eligibility Criteria
High bleeding risk (HBR) patients undergoing percutaneous coronary angiography with history of paroxysmal atrial fibrillation
You may qualify if:
- No chronic atrial fibrillation
- Coronary artery disease
- Percutaneous coronary intervention
You may not qualify if:
- Contraindications to anticoagulation
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
San Raffaele Pisana
Rome, 00100, Italy
Sapienza University
Rome, 00161, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Carlo Gaudio, MD
University Sapienza
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 30, 2019
First Posted
November 5, 2019
Study Start
December 1, 2019
Primary Completion
November 30, 2022
Study Completion
November 30, 2023
Last Updated
September 9, 2022
Record last verified: 2022-09