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Comparison Between Direct Oral Anticoagulation (DOAC) Interruption and DOAC Continuation in Patients Undergoing Elective Invasive Coronary Angiography or Percutaneous Coronary Intervention
RECRUITINGN/ASponsored by Zuyderland Medisch Centrum
Actively Recruiting
PhaseN/A
SponsorZuyderland Medisch Centrum
Started2022-09-01
Est. completion2027-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04977076
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions4
AnticoagulantsAtrial FibrillationCoronary Artery DiseaseHeart Disease
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Actively Recruiting
PhaseN/A
SponsorZuyderland Medisch Centrum
Started2022-09-01
Est. completion2027-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04977076