Study Title: Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG (PACES)
Current Status: Enrolling
Study Overview
This is a prospective, multicenter, open-label, randomized trial comparing OAC with no OAC (1:1 ratio) in patients who develop new-onset POAF after CABG. The primary effectiveness endpoint is the composite of death, stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (VTE) at 90 days after randomization. The primary safety endpoint is BARC (Bleeding Academic Research Consortium) grade 3 or 5 bleeding at 90 days after randomization. The overall intent is to evaluate the trade-off in prevention of thromboembolic events versus an increase in bleeding.
Patients will be randomly assigned to the following treatment strategies:
- OAC-based strategy (experimental arm): OAC with vitamin K antagonist (VKA) with international normalized ratio (INR) target 2-3 or any approved direct oral anticoagulant (apixaban, rivaroxaban, edoxaban or dabigatran) in addition to background antiplatelet therapy with aspirin 75-100 mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)
- Antiplatelet-only strategy (control arm): with aspirin 75-100 mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)
The protocol-specified duration of anticoagulation is 90 days. Patients, who are randomized to the control arm and develop recurrent AF after 30 days, may be crossed-over to an OAC. Accrual is expected to take 36 months. Study follow-up visits will be performed at 90 days and phone follow-up at 180 days.
Data for patients enrolled in the registry will be ascertained from the local clinical site via a review of medical records. The baseline risk profile of registry patients (i.e., patients eligible but unwilling to be randomized) will be analyzed and compared to that of patients randomized in the trial. The usage of anticoagulant and antiplatelet therapies in the registry population overall and baseline CHA2DS2-VASC stroke risk score will also be determined.
For more information on this study, please click here
GCO # 08-1078(13); Current IRB approval period 8/12/2019-7/31/2020
Study Title: LONG-TERM FOLLOW-UP FOR PARTICIPANTS OF: EVALUATION OF OUTCOMES FOLLOWING MITRAL VALVE REPAIR/REPLACEMENT IN SEVERE CHRONIC ISCHEMIC MITRAL REGURGITATION (SMR) AND SURGICAL INTERVENTIONS FOR MODERATE ISCHEMIC MITRAL REGURGITATION (MMR) TRIALS
Current Status: Enrolling
Study Overview
This study is a continuation of two previous studies --- the Severe Ischemic Mitral Regurgitation (SMR) Trial and the Moderate Ischemic Mitral regurgitation (MMR) Trial--- to learn more about patients' health 5-10 years after their mitral valve surgeries. The investigators will collect long-term health information on SMR and MMR trial participants using electronic medical records, patient and/or family input, public records, and healthcare- and vital status-related databases.
For more information on this study, please click here
GCO # 08-1078(12); Current IRB approval period 12/22/19-12/21/20
Study Title: EVALUATING THE BENEFIT OF CONCURRENT TRICUSPID VALVE REPAIR DURING MITRAL SURGERY
Current Status: Enrollment Complete
| Top Enrolling Sites | |
|---|---|
| London Health Sciences Center | 43 |
| University of Maryland | 39 |
| Duke University | 37 |
| Baylor Research Institute | 32 |
| University of Virginia | 28 |
| Hôpital Laval | 27 |
Study Overview
The purpose of the research is to determine whether repairing a tricuspid valve in patients with mild to moderate TR, at the time of planned mitral valve surgery, would improve the heart health of those who receive it compared to those who do not. There are no new or "experimental" procedures being tested in this study: both the mitral valve procedure and the tricuspid valve repair procedure are well established surgeries and are regularly performed together in patients who have severe TR. What is not known with certainty, but what will be tested in this study, is whether patients with a smaller amount of leakage of the tricuspid valve (mild or moderate TR) would benefit from the repair in addition to the mitral valve surgery. At this point, the medical community is split in their opinion on whether surgeons should routinely repair mild to moderate TR in patients who are undergoing planned mitral valve surgery, and this study will answer this question.
For more information on this study, please click here.
(https://www.clinicaltrials.gov/ct2/show/NCT02675244)
This trial will randomize a total of 400 patients at up to 40 sites.
GCO # 08-1078(10); Current annual IRB approval period: 2/16/20-2/15/21
