Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients (TICTAC)

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
David A. Baran, MD, Newark Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT00299221
First received: March 2, 2006
Last updated: May 26, 2015
Last verified: May 2015

March 2, 2006
May 26, 2015
April 2004
June 2009   (final data collection date for primary outcome measure)
Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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.
International Society for Heart and Lung Transplantation Mean Biopsy Score (6 month average)
Complete list of historical versions of study NCT00299221 on ClinicalTrials.gov Archive Site
  • Percent of Patients Alive at One Year Post-transplant [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.
  • mortality
  • Incidence of cytomegalovirus
  • Incidence of Allograft vasculopathy
  • 1 year mean biopsy score
  • risk of new onset diabetes mellitus
  • time to wean corticosteroids
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Immunosuppression
  • Drug: Tacrolimus
    tacrolimus
    Other Name: Prograf
  • Drug: combination therapy
    MMF
    Other Name: mycophenolate mofetil / CellCept
  • Active Comparator: Monotherapy
    Tacrolimus alone
    Intervention: Drug: Tacrolimus
  • Active Comparator: Combination therapy
    tacrolimus with mycophenolate mofetil
    Interventions:
    • Drug: Tacrolimus
    • Drug: combination therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
December 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00299221
TICTAC
No
David A. Baran, MD, Newark Beth Israel Medical Center
Newark Beth Israel Medical Center
Astellas Pharma Inc
Principal Investigator: David A Baran, MD Newark Beth Israel Medical Center
Newark Beth Israel Medical Center
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP