BridgeMD
Compares treatment options for Atrial Fibrillation
Official title LAAO Versus NOAC in Patients with AF and PCI
ClinicalTrials.gov ID: NCT05353140
What this study is testing
What is Rivaroxaban + Clopidogre?
Rivaroxaban + Clopidogre is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for atrial fibrillation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Atrial fibrillation (AF) coincides with coronary artery disease (CAD) shared common risk factors and pathophysiologic pathways. CAD affects approximately 25% of AF patient according to the trial Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM), while in the Global Registry of Acute Coronary Events (GRACE) atrial fibrillation affected about 9% of patients with CAD.
- 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
- Successful PCI for unstable angina or CCS
- Non-valvular atrial fibrillation
- Concomitant at least one of the following conditions: congestive heart failure, hypertension, ≥65yrs, diabetes, previous stroke, TIA or...
- Eligible for long-term novel oral anti-coagulation (NOAC) therapy
- Able to understand and provide informed consent and comply with all study procedures/medications
You likely can't join if
- Patients who meet any of the following criteria will be disqualified from participation in the study: Clinical exclusion criteria:
- Under the age of 18
- Unable to give informed consent or currently participating in another trial and not yet at its primary endpoint
- Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of...
- Concurrent medical condition with a life expectancy of less than 3 years
- Haemodynamical unstable
See the full eligibility criteria
- Successful PCI for unstable angina or CCS
- Non-valvular atrial fibrillation
- Concomitant at least one of the following conditions: congestive heart failure, hypertension, ≥65yrs, diabetes, previous stroke, TIA or thromboembolism
- Eligible for long-term novel oral anti-coagulation (NOAC) therapy
- Able to understand and provide informed consent and comply with all study procedures/medications
- Patients who meet any of the following criteria will be disqualified from participation in the study: Clinical exclusion criteria:
- Under the age of 18
- Unable to give informed consent or currently participating in another trial and not yet at its primary endpoint
- Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)
- Concurrent medical condition with a life expectancy of less than 3 years
- Haemodynamical unstable
- Known contraindication to medications such as heparin, antiplatelet or anticoagulation drugs, or contrast
- PCI for ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI), or experienced a peri-procedural myocardial infarction (MI) caused by PCI
- Known contraindication to LAAO or LAAO is not required
- Comorbidities other than atrial fibrillation that required long term use of anticoagulation (such as implanted a mechanical valve)
- The patient had or is planning to have any cardiac (excluding the current PCI procedure) or non-cardiac treatment or surgical procedure within 30 days prior to or 60 days after the WATCHMAN device implant (e.g...
- Ongoing overt bleeding
- Previous stroke/TIA within 30 days of enrolment
- Symptomatic carotid artery disease
- Severe renal insufficiency (CrCl≤30ml/min) Imaging Exclusion Criteria:
- Left atrial appendage (LAA) thrombus
- High risk patent foramen ovale or atrial septal defect requiring invasive treatment
- Anatomical unsuitable for LAAO
- Rheumatic heart valve disease, mitral valve stenosis (valve area \<1.5cm2)
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shannxi, China
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 Xi'an, Shannxi, China. 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.