Title
Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients
Tacrolimus In Combination, Tacrolimus Alone Compared (TICTAC Trial): A Prospective Randomized Trial Of Minimized Immunosuppression In Adult Heart Transplant Recipients
Phase
Phase 4Lead Sponsor
Newark Beth Israel Medical CenterStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
ImmunosuppressionIntervention/Treatment
tacrolimus atorvastatin quinapril ...Study Participants
150This was a study to compare less intense immunosuppression with a more traditional approach. The hypothesis was that less immunosuppression will provide similar protection against rejection than typical 2-3 drug therapy.
This was a prospective, randomized, controlled (open-label) trial of 2 different strategies of immunosuppression in de novo post-heart transplant patients. The hypothesis was that immunosuppression with tacrolimus and mycophenolate mofetil, coupled with rapid steroid weaning would provide similar anti-rejection efficacy as tacrolimus with only a 2 week course of mycophenolate mofetil but including the same rapid steroid wean.
The primary endpoint was the mean International Society for Heart and Lung Transplantation (ISHLT) biopsy score over the first 6 months post-transplant. Secondary endpoints included the incidence of adverse events over the first year post-transplant, as well as all-cause mortality, 12 month ISHLT biopsy score (mean), along with the incidence of proven cytomegalovirus disease. In addition, the incidence of allograft vasculopathy as assessed by angiography or intravascular ultrasound was compared between groups.
tacrolimus
MMF
tacrolimus with mycophenolate mofetil
Inclusion Criteria: Adult (at least 18 years old) Undergoing a first heart transplant (no heart/kidney transplants), who receive their transplant at one of the study sites Specifically INCLUDED are patients on ventricular assist devices, and allosensitized recipients Exclusion Criteria: Age less than 18 Inability to provide proper informed consent Combined organ transplantation Re-Transplantation
| Event Type | Organ System | Event Term | Monotherapy | Combination Therapy |
|---|
Mean ISHLT biopsy score Biopsies of the heart may be various grades and each is assigned a numerical score. Grade 0 is 0 points, 1A = 1, 1B = 2, grade 2 = 3, grade 3A = 4, Grade 3B = 5, and grade 4 = 6 units. The mean biopsy score is the numeric average of the biopsy scores for the first 6 post-transplant months. Best value is 0, worst score is 6.
Percent of patients alive at one year post-transplant. In other words, all cause mortality over time
Number of patients developing cytomegalovirus disease by 1 year post-transplant
Number of patients diagnosed with allograft vasculopathy / coronary artery disease (CAD) at one year post transplant
Mean ISHLT biopsy score Biopsies of the heart may be various grades and each is assigned a numerical score. Grade 0 is 0 points, 1A = 1, 1B = 2, grade 2 = 3, grade 3A = 4, Grade 3B = 5, and grade 4 = 6 units. The mean biopsy score is the numeric average of the biopsy scores for the first 6 post-transplant months. Best value is 0, worst score is 6.
