Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients (TICTAC)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Tacrolimus In Combination, Tacrolimus Alone Compared (TICTAC Trial): A Prospective Randomized Trial Of Minimized Immunosuppression In Adult Heart Transplant Recipients|
- Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation [ Time Frame: 6 months ]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 [ Time Frame: 1 year ]Percent of patients alive at one year post-transplant. In other words, all cause mortality over time
- Number of Patients With Cytomegalovirus (CMV) at One Year Post-transplant [ Time Frame: 1 year ]Number of patients developing cytomegalovirus disease by 1 year post-transplant
- Number of Patients With Allograft Vasculopathy (CAD) at One Year Post Transplant [ Time Frame: 1 year ]Number of patients diagnosed with allograft vasculopathy / coronary artery disease (CAD) at one year post transplant
- Mean ISHLT Biopsy Score Over First Year Post-transplant [ Time Frame: 1 year ]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.
|Study Start Date:||April 2004|
|Study Completion Date:||December 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Monotherapy
Other Name: Prograf
Active Comparator: Combination therapy
tacrolimus with mycophenolate mofetil
Other Name: PrografDrug: combination therapy
Other Name: mycophenolate mofetil / CellCept
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299221
|United States, New Jersey|
|Newark Beth Israel Medical Center|
|Newark, New Jersey, United States, 07112|
|United States, New York|
|Mt. Sinai Cardiovascular Institute|
|New York, New York, United States, 10029|
|Principal Investigator:||David A Baran, MD||Newark Beth Israel Medical Center|