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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

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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