Clinical trial NCT00299221: Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients
Official title: Tacrolimus In Combination, Tacrolimus Alone Compared (TICTAC Trial): A Prospective Randomized Trial Of Minimized Immunosuppression In Adult Heart Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Immunosuppression
Keywords: immunosuppression
steroid withdrawal
rejection
coronary disease
cytomegalovirus infection
Lead sponsor: Newark Beth Israel Medical Center
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2006-03-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation
timeFrame: 6 months
Secondary outcomes:
measure: Percent of Patients Alive at One Year Post-transplant
timeFrame: 1 year
measure: Number of Patients With Cytomegalovirus (CMV) at One Year Post-transplant
timeFrame: 1 year
measure: Number of Patients With Allograft Vasculopathy (CAD) at One Year Post Transplant
timeFrame: 1 year
measure: Mean ISHLT Biopsy Score Over First Year Post-transplant
timeFrame: 1 year
Other outcomes:
Locations:
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: New York
country: United States
facility: Mt. Sinai Cardiovascular Institute
state: New York
Study officials:
affiliation: Newark Beth Israel Medical Center
name: David A Baran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baran DA, Zucker MJ, Arroyo LH, Alwarshetty MM, Ramirez MR, Prendergast TW, Goldstein DJ, Camacho M, Gass AL, Carr C, Cohen M. Randomized trial of tacrolimus monotherapy: tacrolimus in combination, tacrolimus alone compared (the TICTAC trial). J Heart Lung Transplant. 2007 Oct;26(10):992-7. doi: 10.1016/j.healun.2007.07.022.
citation: Baran DA, Zucker MJ, Arroyo LH, Camacho M, Goldschmidt ME, Nicholls SJ, Prevost-Fernandez J, Carr C, Adams L, Pardi S, Hou V, Binetti M, McCahill J, Chichetti J, Viloria V, Sanagustin MG, Ebuenga-Smith J, Mele L, Martin A, Blicharz D, Wolski K, Olesnicky L, Qian F, Gass AL, Cohen M. A prospective, randomized trial of single-drug versus dual-drug immunosuppression in heart transplantation: the tacrolimus in combination, tacrolimus alone compared (TICTAC) trial. Circ Heart Fail. 2011 Mar;4(2):129-37. doi: 10.1161/CIRCHEARTFAILURE.110.958520. Epub 2011 Jan 7.