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
  Purpose

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.


Condition Intervention Phase
Immunosuppression
Drug: Tacrolimus
Drug: combination therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Newark Beth Israel Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 150
Study Start Date: April 2004
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Monotherapy
Tacrolimus alone
Drug: Tacrolimus
tacrolimus
Other Name: Prograf
Active Comparator: Combination therapy
tacrolimus with mycophenolate mofetil
Drug: Tacrolimus
tacrolimus
Other Name: Prograf
Drug: combination therapy
MMF
Other Name: mycophenolate mofetil / CellCept

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299221

Locations
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
Sponsors and Collaborators
Newark Beth Israel Medical Center
Astellas Pharma Inc
Investigators
Principal Investigator: David A Baran, MD Newark Beth Israel Medical Center
  More Information

Publications:
Responsible Party: David A. Baran, MD, Director, Heart Failure and Transplant Research, Newark Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT00299221     History of Changes
Other Study ID Numbers: TICTAC
Study First Received: March 2, 2006
Results First Received: September 10, 2010
Last Updated: May 26, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Newark Beth Israel Medical Center:
immunosuppression
steroid withdrawal
rejection
coronary disease
cytomegalovirus infection

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on September 03, 2015