Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299221
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2006-03-02
Brief Title:
Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients
Sponsor:
Newark Beth Israel Medical Center
Organization:
Newark Beth Israel Medical Center
Study Overview
Official Title:
Tacrolimus In Combination Tacrolimus Alone Compared TICTAC Trial A Prospective Randomized Trial Of Minimized Immunosuppression In Adult Heart Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TICTAC
Brief Summary:
This 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None