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New treatment option for Atrial Fibrillation
Official title Comparison Between Direct Oral Anticoagulation (DOAC) Interruption and DOAC Continuation in Patients Undergoing Elective Invasive Coronary Angiography or Percutaneous Coronary Intervention
ClinicalTrials.gov ID: NCT04977076
What this study is testing
- What it's testing
- A prospective, multicenter, 1:1 randomized, investigator initiated study. Goal of this study is to examine the safety of uninterrupted periprocedural DOAC use.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients aged \>18 years using DOAC and undergoing elective ICA or PCI.
- Provided signed informed consent
You likely can't join 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 creatinine clearance \<30 mL/min
- Patients simultaneously participating in another clinical trial
- History or condition associated with increased bleeding risk, as listed below:
See the full eligibility criteria
- Patients aged \>18 years using DOAC and undergoing elective ICA or PCI.
- Provided signed informed consent
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Heerlen, Limburg, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Heerlen, Limburg, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.