A Phase 4 interventional study of Direct-acting oral anticoagulation in Coronary Artery Disease, Bleeding and Direct Acting Anticoagulant Adverse Reaction, sponsored by Hospital Universitario La Fe. Recruiting at 4 sites in 2 countries. Per ClinicalTrials.gov, last updated 2024-01-26.
Sponsored by Hospital Universitario La Fe · Phase 4, Interventional, and Prevention
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 200 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Hospital Universitario La Fe is the lead sponsor of 37 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Uninterrupted direct-acting oral anticoagulation in patients undergoing trans-radial percutaneous coronary procedures
Drug: Direct-acting oral anticoagulation
Apixaban Dabigatran Edoxaban Rivaroxaban
Rate of Bleeding Academic Research Consortium (BARC) type 2, 3 or 5
Time frame: 30-day follow-up
Rate of BARC type 3, or 5
Time frame: 30-day follow-up
Rate of all-cause death
Time frame: 30-day follow-up
Rate of cardiac death
Time frame: 30-day follow-up
Rate of stroke
Time frame: 30-day follow-up
Rate of myocardial infarction
Time frame: 30-day follow-up
Rate of definite/probable stent thrombosis
Time frame: 30-day follow-up
Rate of definite stent thrombosis
Time frame: 30-day follow-up
Rate of target-lesion revascularization
Time frame: 30-day follow-up
Rate of target-vessel revascularization
Time frame: 30-day follow-up
Plan to share: Undecided — The data that support the findings of this study will be available from the corresponding author on reasonable request.
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Hospital Universitario La Fe