Managing antiplatelet therapy during surgeries for patients with recent heart procedures
Management of Antiplatelet Regimen During Surgical Procedures (MARS Registry)
Baylor Research Institute · NCT03981835
This study is trying to see how managing blood-thinning medications during surgeries affects patients who have recently had heart procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1492 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baylor Research Institute (other) |
| Locations | 5 sites (Jacksonville, Florida and 4 other locations) |
| Trial ID | NCT03981835 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to collect data on the management of dual antiplatelet therapy (DAPT) in patients who have undergone percutaneous coronary intervention (PCI) and are scheduled for non-cardiac surgeries (NCS) or cardiac surgeries (CS). The registry will capture pre-operative and post-operative data to assess the risks of bleeding and ischemic events associated with different DAPT management strategies. It will involve multiple centers across the U.S. and will be monitored for data accuracy and compliance with regulations. The findings could inform future randomized clinical trials in this area.
Who should consider this trial
Good fit: Ideal candidates include patients who have had PCI within the last two years and are currently on or have an indication for DAPT, scheduled for NCS or CS.
Not a fit: Patients requiring emergent surgery within six hours post-PCI on DAPT may not benefit from this study due to the inability to obtain informed consent.
Why it matters
Potential benefit: If successful, this study could improve the safety and outcomes of surgical procedures for patients on antiplatelet therapy.
How similar studies have performed: While there are existing studies on antiplatelet therapy, this registry approach is designed to fill gaps in current knowledge and may provide novel insights into perioperative management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with PCI within the past 2 years who: a. Are currently on DAPT, OR b. Have a current indication for DAPT * Scheduled for NCS or CS. * Willing and able to provide an informed consent (if needed based on institutional IRB requirements). Exclusion Criteria: * Emergent (6 hours) surgery post-PCI on DAPT that precludes a thorough informed consent process.
Where this trial is running
Jacksonville, Florida and 4 other locations
- University of Florida — Jacksonville, Florida, United States (RECRUITING)
- Dallas VA Medical Center — Dallas, Texas, United States (COMPLETED)
- Baylor Scott & White Research Institute — Dallas, Texas, United States (RECRUITING)
- UT Southwestern Medical Center — Dallas, Texas, United States (COMPLETED)
- Mary Washington Hospital — Fredericksburg, Virginia, United States (COMPLETED)
Study contacts
- Study coordinator: Subhash Banerjee, MD
- Email: subhash.banerjee@bswhealth.org
- Phone: 469-800-7400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Surgery, Surgery, Percutaneous Coronary Intervention, Surgery--Complications