NCT04977076 Comparison Between Direct Oral Anticoagulation (DOAC) Interruption and DOAC Continuation in Patients Undergoing Elective Invasive Coronary Angiography or Percutaneous Coronary Intervention
| NCT ID | NCT04977076 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zuyderland Medisch Centrum |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,270 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,270 participants in total. It began in 2022-09-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A prospective, multicenter, 1:1 randomized, investigator initiated study. Goal of this study is to examine the safety of uninterrupted periprocedural DOAC use.
Eligibility Criteria
Inclusion Criteria: * Patients aged \>18 years using DOAC and undergoing elective ICA or PCI. * Provided signed informed consent Exclusion Criteria: 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 creatinine clearance \<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 * Known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis), or Alanine aminotransferase (ALT) \>3 x the upper limit of normal. * Participation in another clinical trial
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04977076 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04977076 currently recruiting?
Yes, NCT04977076 is actively recruiting participants. Contact the research team at sanne.janssen@zuyderland.nl for enrollment information.
Where is the NCT04977076 trial being conducted?
This trial is being conducted at Heerlen, Netherlands.
Who is sponsoring the NCT04977076 clinical trial?
NCT04977076 is sponsored by Zuyderland Medisch Centrum. The trial plans to enroll 1,270 participants.
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