NCT04977076

Comparison Between Direct Oral Anticoagulation (DOAC) Interruption and DOAC Continuation in Patients Undergoing Elective Invasive Coronary Angiography or Percutaneous Coronary Intervention

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,214 (estimated)
• Sponsor: Zuyderland Medisch Centrum · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multicenter, 1:1 randomized, investigator initiated study. Goal of this study is to examine the safety of uninterrupted periprocedural NOAC use.

Detailed description

Rationale: Patients with atrial fibrillation (AF) often have coexisting coronary artery disease (CAD). An estimated 5 to 15% of all AF patients will require coronary stenting. Direct Oral Anticoagulants (DOAC) are more commonly used in preventing thromboembolic complications in patients with AF, thereby substituting the use of Vitamin-K Antagonists (VKA). Therefore, many patients undergoing invasive coronary angiography (ICA) and percutaneous coronary intervention (PCI) are taking direct oral anticoagulants (DOAC). In patients using VKA it is recommended to defer elective coronary angiography until INR is \<2.2 when radial artery access is used. However, no large clinical trials have proven the safety of continuing DOAC use when undergoing ICA or PCI. The current guidelines recommend interrupting DOAC treatment at least 24 before ICA or PCI; however, this recommendation is only based on limited data. Clinical decisions on DOAC use must therefore be based on clinical trials in which substantial numbers of patients with Acute Coronary Syndrome (ACS) were included. Objective: To study the safety of DOAC continuation in patients undergoing ICA or PCI. Study design: A prospective, multicenter, 1:1 randomized, investigator initiated study. Study population: Patients aged \>18 years using DOAC and undergoing elective ICA or PCI. Intervention: The intervention group will continue using DOAC as usual. No adjustments of DOAC use will be made before and after ICA or PCI. The control group will receive standard care. DOAC use will be interrupted at least 24-48 hours in advance of ICA or PCI, based on renal clearance and DOAC specimen. Main study parameters/endpoints: : Non-CABG related in-hospital major bleeding (BARC 3 or 5). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Only a small burden is associated with participation. Patients are asked to fill out a questionnaire after 30 days. Patients in the control group may have a mildly higher risk of thromboembolic complications and patients in the intervention group may have a mildly higher risk of bleeding complications.

Conditions

• Atrial Fibrillation
• Coronary Artery Disease
• Anticoagulants

Interventions

Type	Name	Description
OTHER	Uninterrupted NOAC use	Continuing NOAC use in advance of elective CAG or PCI.
OTHER	Interrupted NOAC use	Usual care, interruption of NOAC prior to procedure.

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-07-26
• Last updated: 2021-07-26