Using direct oral anticoagulation during transradial coronary procedures
Uninterrupted Direct-acting Oral Anticoagulation in Patients Undergoing Transradial Percutaneous Coronary Procedures
This study is testing whether it's safe for patients on blood thinners to keep taking them during certain heart procedures to see if it leads to fewer bleeding problems.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Hospital Universitario La Fe Academic / other |
| Locations | 4 sites (Rozzano, Milan and 3 other locations) |
| Trial ID | NCT05292846 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety of continuing direct-acting oral anticoagulation (DOAC) in patients undergoing transradial percutaneous coronary procedures. It is a single-arm, open-label pilot study that aims to include around 200 patients who are on DOAC and require these procedures. The study will monitor for bleeding complications, specifically BARC type 3 or 5 bleeding, to assess the safety of uninterrupted anticoagulation during the periprocedural period. If a predetermined number of bleeding events occur, patient recruitment will be halted to ensure participant safety.
Who should consider this trial
Good fit: Ideal candidates are patients on DOAC who need diagnostic or therapeutic transradial coronary procedures.
Not a fit: Patients with major active bleeding, cardiogenic shock, or those unable to comply with study protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the risk of thromboembolic events in patients requiring coronary procedures while minimizing bleeding complications.
How similar studies have performed: Previous pilot studies with similar designs have shown promising results, suggesting that this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients under anticoagulation with DOAC and any indication for diagnostic or therapeutic trans-radial percutaneous coronary procedures. At least 25% of the population undergoing PCI will be included. Exclusion Criteria: 1. Aged \< 18 years 2. Cardiogenic shock 3. Major active bleeding at the time of the procedure 4. Use of mechanical circulatory support 5. Chronic total occlusions 6. Pre-planned vascular access different from radial artery access (i.e. femoral, brachial, ulnar) 7. Inability to provide informed consent 8. Unable to understand and follow study-related instructions or unable to comply with study protocol 9. Currently participating in another trial 10. Pregnant women
Where this trial is running
Rozzano, Milan and 3 other locations
- Humanitas Research Hospital — Rozzano, Milan, Italy (Not_yet_recruiting)
- Hospital del Mar — Barcelona, Spain (Recruiting)
- Hospital La Paz — Madrid, Spain (Recruiting)
- Hospital Universitario y Politécnico La Fe — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Jorge Sanz Sanchez, MD, PhD
- Email: sjorge4@gmx.com
- Phone: 440087
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.