Comparison Between Direct Oral Anticoagulation (DOAC) Interruption and DOAC Continuation in Patients Undergoing Elective Invasive Coronary Angiography or Percutaneous Coronary Intervention
Recruiting · NCT04977076 · Interventional (participants receive a specific treatment) · Lead sponsor: Zuyderland Medisch Centrum
View the official record on ClinicalTrials.gov →Interventions studied
Interrupted DOAC useUninterrupted DOAC use
What this trial is about
A prospective, multicenter, 1:1 randomized, investigator initiated study. Goal of this study is to examine the safety of uninterrupted periprocedural DOAC use.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Zuyderland MC - Heerlen, Limburg, Netherlands