What is the PROACT study?
Source: HealthCentral.comThe purpose of PROACT is to determine whether or not patients with the On-X® Valve can be maintained safely on lower doses of Coumadin® ("blood thinner" or anticoagulant) or antiplatelet drugs only (aspirin and Plavix®).
PROACT is being conducted in 40 hospitals in the U.S. and will enroll 1,200 patients. Patients in the study must commit to a 5 year follow-up. All patients that meet the criteria are invited to participate; however, if a patient chooses not to participate in the study or does not meet the criteria, he or she can still receive the On-X® valve.
This is a randomized study. This means that after 3 months, patients will be selected by computer either to be given a lower dose of drugs or to continue using standard therapy. Participants will be assigned to one of these therapy groups:
- Aortic Group I: After three months of normal doses of medication, patients will receive a lower dose of Coumadin® and a baby aspirin.
- Aortic Group II: After three months of normal doses of Coumadin® and aspirin, patients will stop Coumadin® and change to Plavix® and aspirin.
- Aortic Control Group: Patients will take the normal amount of Coumadin and aspirin.
- Mitral Valve Group III: After three months of normal doses of medication, patients will take a reduced amount of Coumadin® and a baby aspirin.
- Mitral Valve Control Group: Patients will take normal doses of Coumadin® and aspirin.
At the conclusion of the study, PROACT may prove that patients who need a valve replacement in some cases do not need anticoagulant therapy or that they can take a much lower dose of anticoagulant therapy than is currently recommended.
Learn more about the PROACT Study
