NCT05292846

Uninterrupted Direct-acting Oral Anticoagulation in Patients Undergoing Transradial Percutaneous Coronary Procedures

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Hospital Universitario La Fe · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

The study design is an investigator-initiated, single-arm, open-label, pilot study in patients treated with DOAC undergoing trans-radial percutaneous coronary procedures. Because of the exploratory nature of this study, no formal sample size calculations are required. On the basis of previous pilot studies with similar designs, a sample of 200 patients is planned; with a safety stopping rule based on the occurrence of BARC type 3 or 5 bleeding. In the present trial, if during the enrollment period more than 3 cases of BARC 3 or 5 bleeding occur up to 30-day follow-up, patient recruitment will be terminated. This number is based on the reported 1.6% BARC type 3 or 5 bleeding in patients undergoing transradial percutaneous coronary procedures.

Conditions

• Coronary Artery Disease
• Bleeding
• Direct Acting Anticoagulant Adverse Reaction

Interventions

Type	Name	Description
DRUG	Direct-acting oral anticoagulation	Apixaban Dabigatran Edoxaban Rivaroxaban

Timeline

• Start date: 2022-01-20
• Primary completion: 2024-02-20
• Completion: 2024-04-20
• First posted: 2022-03-23
• Last updated: 2024-01-26

Locations

4 sites across 2 countries: Italy, Spain