Interventional Recruiting Phase 4
NCT05292846 on ClinicalTrials.gov
Uninterrupted Direct-acting Oral Anticoagulation in Patients Undergoing Transradial Percutaneous Coronary Procedures
- Sponsor: Hospital Universitari i Politècnic La Fe
- Enrollment: 200 (Estimated)
- Study start: 2022-01-20 (Actual)
- Primary completion: 2024-02-20 (Estimated)
- Study completion: 2024-04-20 (Estimated)
- Allocation: N/a
- InterventionModel: Single Group
- Masking: None
- PrimaryPurpose: Prevention
Brief Summary
Up to 20-30% of patients who are candidates for direct oral anticoagulation (DOAC) present with concomitant ischemic heart disease and often require coronary angiography with or without percutaneous coronary intervention (PCI). The decision whether to continue the DOAC throughout periprocedural period or interrupt DOAC before planned procedure represents a substantial challenge in daily clinical practice.
The objective of this study is to evaluate the safety of uninterrupted direct-acting oral anticoagulation in patients undergoing trans-radial percutaneous coronary procedures.
Conditions
- Coronary Artery Disease
- Bleeding
- Direct Acting Anticoagulant Adverse Reaction
Intervention / Treatment
- Drug: Direct-acting oral anticoagulation
Primary Outcome Measures
- Rate of Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 (30-day follow-up)
Countries
Italy, Spain
Locations and Investigators
-
Humanitas Research Hospital, Rozzano, Italy (Not yet recruiting)
- Giulio Stefanini, Prof
- Giulio Stefanini, Prof (Principal Investigator)
- Mauro Chiarito, MD
-
Hospital del Mar, Barcelona, Spain (Recruiting)
- Beatriz Vaquerizo Montilla
-
Hospital La Paz, Madrid, Spain (Recruiting)
- Alfonso Jurado Román
-
Hospital Universitario y Politécnico La Fe, Valencia, Spain (Recruiting)
- Jorge Sanz Sanchez, MD, PhD
- Jose Luis Diez Gil, MD, PhD