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

NCT04977076 | Unknown

• 1 other identifier: METCZ20210099
• Study Type: interventional
• Target: 1,214
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Atrial Fibrillation; Coronary Artery Disease; Anticoagulants

Outcome Measures

Primary Outcomes (1)

• Major Bleeding

  Non-CABG related in-hospital major bleeding (BARC 3 or 5)

  30 days

Study Arms (2)

Interrupted NOAC use (group 1)

ACTIVE COMPARATOR

Patients in group 1 will receive standard care. Therefore, DOAC use will be interrupted at least 24 hours in advance of ICA or PCI. Based on the renal clearance, last DOAC intake may be extended to 48 hours prior to the procedure \[Table 2\]. After the procedure, patients will continue using their DOAC as usual.

Other: Interrupted NOAC use

Uninterrupted NOAC use (group 2)

EXPERIMENTAL

In group 2, all patients will continue to use their specific DOAC as usual. This means that no adjustments of DOAC use will be made before and after ICA or PCI. After the procedure patients will continue to use DOAC from the next planned dose.

Other: Uninterrupted NOAC use

Interventions

Uninterrupted NOAC use OTHER

Continuing NOAC use in advance of elective CAG or PCI.

Uninterrupted NOAC use (group 2)

Interrupted NOAC use OTHER

Usual care, interruption of NOAC prior to procedure.

Interrupted NOAC use (group 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged \>18 years using DOAC and undergoing elective ICA or PCI.
• Provided signed informed consent

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Any of the following:
• Patients initially presenting with Acute Coronary Syndrome (STEMI, NSTEMI, UA)
• Patients \<18 years old
• Calculated CLCR \<30 mL/min
• Patients simultaneously participating in another clinical trial
• History or condition associated with increased bleeding risk, as listed below:
• Major surgical procedure within 30 days before the procedure
• Known inaccessible radial artery during previous procedure
• History of GI bleeding in the previous 6 months
• History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding
• Chronic bleeding disorder
• Known intracranial neoplasm, arteriovenous malformation, or aneurysm
• Known anemia with last measured haemoglobin value \<6 mmol/L \[9.67 g/dL\]
• Current pregnancy or breast-feeding

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

MeSH Terms

Conditions

Atrial Fibrillation; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Jasper Luijkx, MD

CONTACT

08854597522; j.luijkx@zuyderland.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, multicenter, 1:1 randomized, investigator initiated study.

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 26, 2021
• Study Start: October 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 26, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share