Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients

Immunosuppression Clinical Trial

— TICTAC  

Official title:

Tacrolimus In Combination, Tacrolimus Alone Compared (TICTAC Trial): A Prospective Randomized Trial Of Minimized Immunosuppression In Adult Heart Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00299221
• Other study ID #: TICTAC
• Status: Completed
• Phase: Phase 4
• First received: March 2, 2006
• Last updated: May 26, 2015
• Start date: April 2004
• Est. completion date: December 2009

Study information

• Verified date: May 2015
• Source: Newark Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immunosuppression

Intervention

Drug:
• Tacrolimus
tacrolimus
• combination therapy
MMF

Locations

Country	Name	City	State
United States	Mt. Sinai Cardiovascular Institute	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Newark Beth Israel Medical Center	Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Lun — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation	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.	6 months	Yes
Secondary	Percent of Patients Alive at One Year Post-transplant	Percent of patients alive at one year post-transplant. In other words, all cause mortality over time	1 year	Yes
Secondary	Number of Patients With Cytomegalovirus (CMV) at One Year Post-transplant	Number of patients developing cytomegalovirus disease by 1 year post-transplant	1 year	Yes
Secondary	Number of Patients With Allograft Vasculopathy (CAD) at One Year Post Transplant	Number of patients diagnosed with allograft vasculopathy / coronary artery disease (CAD) at one year post transplant	1 year	Yes
Secondary	Mean ISHLT Biopsy Score Over First 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.	1 year	Yes