Intimal ProliferationPhase 4OCTandCAVNCT02254668
Intracoronary Analysis of Cardiac Allograft Vasculopathy by Means of Optical Coherence Tomography
A Phase 4 study testing Protocol with Everolimus (Certican®) and Protocol with Mycophenolate mofetil (CellCept®) in people with Intimal Proliferation and Immunosuppression, run by University of Zurich at 1 site in Switzerland.
Trial summary
Randomized prospective multi-center imaging study which investigates the impact of different immunosuppressive protocols (Everolimus (Certican®) or Mycophenolate mofetil (CellCept®)) on cardiac allograft vasculopathy (CAV) in heart transplanted patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intimal Proliferation, Immunosuppression
- What is being tested?
- Protocol with Everolimus (Certican®) and Protocol with Mycophenolate mofetil (CellCept®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2013to Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with heart transplantation
- Patient with coronary artery disease
- Age between 18 and 80 years
Who cannot join
- Renal insufficiency (> 265 µmol/l)
- Incapability to give informed consent
- Cardiogenic shock of patient with KILLIP III or IV
- pregnant or breast feeding females
- insufficient contraception (only for substudy 3)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Division of Cardiology
Zurich, Canton of Zurich, 8091
Christian Templin, MD, PhD, +41 (0)44 / 255 9585, christian.templin@usz.ch
Frank Ruschitzka, Professor, +41 (0)44 / 255 3957, frank.ruschitzka@usz.ch
About this study
Official title: Intracoronary Analysis of Cardiac Allograft Vasculopathy in Comparison to Coronary Artery Disease by Means of Optical Coherence Tomography
Randomized prospective multi-center imaging study which investigates the impact of different immunosuppressive protocols (Everolimus (Certican®) or Mycophenolate mofetil (CellCept®)) on cardiac allograft vasculopathy (CAV) in heart transplanted patients. Maximal intima-thickness will be visualized by optical coherence tomography (OCT) to assess the progression of CAV.
Read the detailed description
In summary, the aim of the study is to examine the effect of the immunosuppressive agent Everolimus (Certican) on the development of cardiac allograft vasculopathy (CAV).
Therefore the study is divided in three sections:
Substudy 1: Evaluation of morphological differences between between CAD and CAV.
Substudy 2: Analysis of cardiovascular risk factors (e.g. hypertension) under a specific immunosuppressive protocol in patients with CAV.
Substudy 3: Prospective, randomized analysis of the influence of different immunosuppressive protocols in patients with CAV.
Primary endpoint of the study will be the adaption of intimal thickness after 10 years, analysed by means of optical coherence tomography.
In addition to the explanations above the most important in- and exclusion criteria are listed below:
Inclusion Criteria:
- Patients after heart transplantation
- Patients with coronary artery disease (CAD)
- Age 18-80 years
Exclusion Criteria:
- Contraindication of Everolimus/Sirolimus or adjuvants
- Renal insufficiency (Creatinine > 265 µmol/l)
- Cardiogenic shock or patients with Killip*-Class III or IV (*name)
- Pregnant or breast feeding females
- insufficient contraception (only for substudy 3)
- Conditions
- Intimal Proliferation, Immunosuppression
- Being tested
- Protocol with Everolimus (Certican®), Protocol with Mycophenolate mofetil (CellCept®)
- Keywords
- intima, thickness, transplantation, cardiology, immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol with Everolimus (Certican®)Other
Also called Randomizaiton by SecuTrial
Electronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®).
Protocol with Mycophenolate mofetil (CellCept®)Other
Also called Randomizaiton by SecuTrial
Electronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®).
| Study group | Role | What they receive |
|---|---|---|
| Everolimus (Certican®) | Experimental | Electronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®). No protocol with Mycophenolate mofetil (CellCept®). Daily dosage administered depending on blood concentration (control interval 6-12 months) Receives: Other: Protocol with Everolimus (Certican®) |
| Mycophenolate mofetil (CellCept®) | Active comparator | Electronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®). No protocol with Everolimus (Certican®). Daily dosage administered depending on blood concentration (control interval 6-12 months) Receives: Other: Protocol with Mycophenolate mofetil (CellCept®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intimal Thickness
Assessment is usually performed by intracoronary angiography and endomyocardial biopsy which is routinely performed <1 year after heart transplantation. Furthermore, assessment interval will be defined according to the result of these investigational procedures. If there is a diagnosis of CAV the interval will be one year, if not a follow-up examination in two years will be sufficient.
Measured: Assessment intervals of patients with CAV is 1 year and 2 years in patients without CAV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startDec 2013
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimal ProliferationStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Christian Templin, MD, PhD, Principal investigator, University Hospital Zurich (Switzerland), Division of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254668
- Sponsor's protocol ID
- KEK-ZH_Nr. 2012-0409
- Acronym
- OCTandCAV
- Status last verified
- Sep 2014
- First submitted
- 29 Dec 2013
- Last updated
- 2 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracoronary Analysis of Cardiac Allograft Vasculopathy in Comparison to Coronary Artery Disease by Means of Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT02254668
- Acronym / sponsor ID
- OCTandCAV / KEK-ZH_Nr. 2012-0409
- Conditions
- Intimal Proliferation, Immunosuppression
- Keywords
- intima, thickness, transplantation, cardiology, immunosuppression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Dec 2013
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 2 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized prospective multi-center imaging study which investigates the impact of different immunosuppressive protocols (Everolimus (Certican®) or Mycophenolate mofetil (CellCept®)) on cardiac allograft vasculopathy (CAV) in heart transplanted patients. Maximal intima-thickness will be visualized by optical coherence tomography (OCT) to assess the progression of CAV.
Detailed description
In summary, the aim of the study is to examine the effect of the immunosuppressive agent Everolimus (Certican) on the development of cardiac allograft vasculopathy (CAV).
Therefore the study is divided in three sections:
Substudy 1: Evaluation of morphological differences between between CAD and CAV.
Substudy 2: Analysis of cardiovascular risk factors (e.g. hypertension) under a specific immunosuppressive protocol in patients with CAV.
Substudy 3: Prospective, randomized analysis of the influence of different immunosuppressive protocols in patients with CAV.
Primary endpoint of the study will be the adaption of intimal thickness after 10 years, analysed by means of optical coherence tomography.
In addition to the explanations above the most important in- and exclusion criteria are listed below:
Inclusion Criteria:
- Patients after heart transplantation
- Patients with coronary artery disease (CAD)
- Age 18-80 years
Exclusion Criteria:
- Contraindication of Everolimus/Sirolimus or adjuvants
- Renal insufficiency (Creatinine > 265 µmol/l)
- Cardiogenic shock or patients with Killip*-Class III or IV (*name)
- Pregnant or breast feeding females
- insufficient contraception (only for substudy 3)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Everolimus (Certican®) | Experimental | Other: Protocol with Everolimus (Certican®)Electronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®). No protocol with Mycophenolate mofetil (CellCept®). Daily dosage administered depending on blood concentration (control interval 6-12 months) |
| Mycophenolate mofetil (CellCept®) | Active comparator | Other: Protocol with Mycophenolate mofetil (CellCept®)Electronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®). No protocol with Everolimus (Certican®). Daily dosage administered depending on blood concentration (control interval 6-12 months) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with heart transplantation
- Patient with coronary artery disease
- Age between 18 and 80 years
Key exclusion criteria (5 listed)
- Renal insufficiency (> 265 µmol/l)
- Incapability to give informed consent
- Cardiogenic shock of patient with KILLIP III or IV
- pregnant or breast feeding females
- insufficient contraception (only for substudy 3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protocol with Everolimus (Certican®)Also: Randomizaiton by SecuTrialElectronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®). | Other | Everolimus (Certican®) |
| Protocol with Mycophenolate mofetil (CellCept®)Also: Randomizaiton by SecuTrialElectronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®). | Other | Mycophenolate mofetil (CellCept®) |
Primary outcome
Intimal Thickness
Time frame: Assessment intervals of patients with CAV is 1 year and 2 years in patients without CAV
Assessment is usually performed by intracoronary angiography and endomyocardial biopsy which is routinely performed <1 year after heart transplantation. Furthermore, assessment interval will be defined according to the result of these investigational procedures. If there is a diagnosis of CAV the interval will be one year, if not a follow-up examination in two years will be sufficient.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
- Informations about Optical Coherence Tomography (OCT)Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Templin, MD, PhD principal investigator
University Hospital Zurich (Switzerland), Division of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Protocol with Everolimus (Certican®) and Protocol with Mycophenolate mofetil (CellCept®) in people with Intimal Proliferation and Immunosuppression, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Templin, MD, PhD (+41 (0)44 / 255 9585, christian.templin@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intimal Thickness (time frame: Assessment intervals of patients with CAV is 1 year and 2 years in patients without CAV). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2014.