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Completed

NCT Number: NCT00299221

Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in 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.

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Key information

Conditions

Immunosuppression Behavior Cardiovascular Diseases Coronary Disease Cytomegalovirus Infections DNA Virus Infections Heart Diseases Herpesviridae Infections Infections Myocardial Ischemia Rejection, Psychology Social Behavior Vascular Diseases Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Newark Beth Israel Medical Center, Newark, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

tacrolimus

Other names: Prograf

Combination therapy

Drug

MMF

Other names: mycophenolate mofetil / CellCept

Primary outcomes

  1. Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation

    Time frame: 6 months

    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 outcomes

  1. Percent of Patients Alive at One Year Post-transplant

    Time frame: 1 year

    Percent of patients alive at one year post-transplant. In other words, all cause mortality over time

  2. Number of Patients With Cytomegalovirus (CMV) at One Year Post-transplant

    Time frame: 1 year

    Number of patients developing cytomegalovirus disease by 1 year post-transplant

  3. Number of Patients With Allograft Vasculopathy (CAD) at One Year Post Transplant

    Time frame: 1 year

    Number of patients diagnosed with allograft vasculopathy / coronary artery disease (CAD) at one year post transplant

  4. Mean ISHLT Biopsy Score Over First Year Post-transplant

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Newark Beth Israel Medical Center

Other

Collaborators

  • Astellas Pharma Inc

Registry information

Official study title

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

Acronym: TICTAC

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Mar 6, 2006
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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