Heart-lung Transplant RejectionPhase 3ARCHERNCT01795729
Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction
A Phase 3 study testing Stent and optimal medical therapy in people with Heart-lung Transplant Rejection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of the study is to compare optimal medical therapy alone versus percutaneous coronary intervention on top of medical therapy in the setting of heart transplant recipient coronary artery disease in a randomized trial.The primary endpoint assessed at 1 year is the composite of death, myocardial infarction, need… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart-lung Transplant Rejection
- What is being tested?
- Stent and optimal medical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Feb 2015
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years old
- Heart transplant recipient
- Stable clinical situation
- One or several non-critical coronary stenoses (≥ 50% et ≤ 75% visually or QCA-assessed diameter stenosis) considered as adequate for coronary stenting by the operator
- Left ventricular ejection fraction ≥ 40%
- Informed consentement signed by the patient
Who cannot join
- Acute coronary syndrome
- In-stent restenosis
- Proof of an extensive myocardial ischemia (≥ 7/17 segments ASE model)
- Coronary stenosis considered as critical by the operators with slow flow
- ACC/AHA Class IA indication for revascularization :
- vessel disease with left ventricular dysfunction
Show all 12Show fewer
- Left main stenosis
- Severe proximal LAD stenosis
- Contra-indication to dual antiplatelet therapy
- Decompensated heart failure at the time of randomization
- Pregnant or breast-feeding women- Patients participating to another clinical research within 30 days before randomization- life expectancy < 1 y
- Patients unable to observe strict medical therapy and follow-up within 1 year after randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction: THE ARCHER TRIAL
The aim of the study is to compare optimal medical therapy alone versus percutaneous coronary intervention on top of medical therapy in the setting of heart transplant recipient coronary artery disease in a randomized trial.The primary endpoint assessed at 1 year is the composite of death, myocardial infarction, need for transitory or permanent ventricular assist device implantation, myocardial revascularization, occurrence or worsening of heart failure, any graft dysfunction and/or a decrease of left ventricular ejection fraction of at least 25% compared to baseline. The hypothesis of the study is the superiority of the interventional management over medical therapy alone in preventing the occurrence of the primary endpoint of the study.
Read the detailed description
The hypothesis of the study is the superiority of the interventional management over medical therapy alone in preventing the occurrence of the primary endpoint of the study assessed 1 year after randomization.
Objectives: To demonstrate the superiority of the interventional management on top of optimal medical therapy over optimal medical therapy alone in preventing the occurrence of the primary endpoint of the study assessed 1 year after randomization
Design : Multicenter, prospective randomized 1 :1, open-label blinded endpoint study
Target population : Heart transplant recipients, aged ≥18 years, without coronary artery disease-related symptoms, with angiographically significant coronary artery stenoses (≥50% anatomically adequate for a revascularization by coronary angioplasty with stent implantation, with no contraindication to dual antiplatelet therapy associating aspirin and a P2Y12 inhibitorfor a duration of 12 monthsand with ni grade IA ACC/AHA indication for revascularization
Inclusion period: 12 months (may be extended based on the inclusion rythme)
Maximum duration of participation for patients : 13 months
Total duration of the study : 37 months
Primary endpoint : The composit of death, myocardial infarction, retransplantation, implantation of transitory or definitve ventricular assist devices, new or worsening heart failure, graft failure and/or a decrease of left ventricular ejection fraction of at least 25% compared to baseline.The occurrence of any event qualifying for the primary endpoint will be assessed by a Cox survival analysis stratified on center.The primary endpoint will be assessed 12 months after randomization.
Secondary endpoints : Any of the individual events defining the primary outcome at 1 year
Number of patients to be included and power calculation : 80 patients per group. A 1 year primary endpoint rate of 30% in the active and 50% in with an inclusion period of 24 months and alpha=5% warants a 90% power using a cox model.
- Conditions
- Heart-lung Transplant Rejection
- Being tested
- Stent, optimal medical therapy
- Keywords
- Heart transplant, Coronary artery disease, Allograft vascular disease, Coronary stent, Optimal medical therapy, Prognosis
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StentDevice
Also called Any type of approved bare metal or drug-eluting coronary stent
Coronary revascularization
optimal medical therapyDrug
Also called Any treatment required at the physicians discretion for the treatment of the patient
Dual antiplatelet therapy: aspirin and a P2Y12 inhibitor as indicated
| Study group | Role | What they receive |
|---|---|---|
| 1: Coronary stent+optimal medical therapy | Experimental | Coronary stent on top of optimal medical therapy Receives: Device: Stent; Drug: optimal medical therapy |
| 2: Optimal medical therapy | Active comparator | Optimal medical therapy Receives: Drug: optimal medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composit of death, myocardial infarction, retransplantation, implantation of transitory or definitive ventricular assist devices, new or worsening heart failure, graft failure and/or a decrease of left ventricular ejection fraction of at least 25%
The composit of death, myocardial infarction, retransplantation, implantation of transitory or definitive ventricular assist devices, new or worsening heart failure, graft failure and/or a decrease of left ventricular ejection fraction of at least 25% at 1 year
Measured: at 1 year
Secondary outcomes (6)
Death at 1 year
Measured: at 1 year
myocardial infarction at 1 year
Measured: at 1 year
Retransplantation at 1 year
Measured: at 1 year
implantation of transitory or definitive ventricular assist devices at 1 year
Measured: at 1 year
new or worsening heart failure at 1 year
Measured: at 1 year
graft failure and/or a decrease of left ventricular ejection fraction of at least 25% at 1 year compared to baseline
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart-lung Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farzin BEYGUI, MD, PhD, Study director, Assistance Publique - Hôpitaux de ParisPascal LEPRINCE, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisSaida VARNOUS, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795729
- Sponsor's protocol ID
- P081262
- Other IDs
- 2010-A01516-33
- Acronym
- ARCHER
- Status last verified
- Oct 2015
- First submitted
- 19 Feb 2013
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction: THE ARCHER TRIAL
- ClinicalTrials.gov ID
- NCT01795729
- Acronym / sponsor ID
- ARCHER / P081262
- Conditions
- Heart-lung Transplant Rejection
- Keywords
- Heart transplant, Coronary artery disease, Allograft vascular disease, Coronary stent, Optimal medical therapy, Prognosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Feb 2013 (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.
The aim of the study is to compare optimal medical therapy alone versus percutaneous coronary intervention on top of medical therapy in the setting of heart transplant recipient coronary artery disease in a randomized trial.The primary endpoint assessed at 1 year is the composite of death, myocardial infarction, need for transitory or permanent ventricular assist device implantation, myocardial revascularization, occurrence or worsening of heart failure, any graft dysfunction and/or a decrease of left ventricular ejection fraction of at least 25% compared to baseline. The hypothesis of the study is the superiority of the interventional management over medical therapy alone in preventing the occurrence of the primary endpoint of the study.
Detailed description
The hypothesis of the study is the superiority of the interventional management over medical therapy alone in preventing the occurrence of the primary endpoint of the study assessed 1 year after randomization.
Objectives: To demonstrate the superiority of the interventional management on top of optimal medical therapy over optimal medical therapy alone in preventing the occurrence of the primary endpoint of the study assessed 1 year after randomization
Design : Multicenter, prospective randomized 1 :1, open-label blinded endpoint study
Target population : Heart transplant recipients, aged ≥18 years, without coronary artery disease-related symptoms, with angiographically significant coronary artery stenoses (≥50% anatomically adequate for a revascularization by coronary angioplasty with stent implantation, with no contraindication to dual antiplatelet therapy associating aspirin and a P2Y12 inhibitorfor a duration of 12 monthsand with ni grade IA ACC/AHA indication for revascularization
Inclusion period: 12 months (may be extended based on the inclusion rythme)
Maximum duration of participation for patients : 13 months
Total duration of the study : 37 months
Primary endpoint : The composit of death, myocardial infarction, retransplantation, implantation of transitory or definitve ventricular assist devices, new or worsening heart failure, graft failure and/or a decrease of left ventricular ejection fraction of at least 25% compared to baseline.The occurrence of any event qualifying for the primary endpoint will be assessed by a Cox survival analysis stratified on center.The primary endpoint will be assessed 12 months after randomization.
Secondary endpoints : Any of the individual events defining the primary outcome at 1 year
Number of patients to be included and power calculation : 80 patients per group. A 1 year primary endpoint rate of 30% in the active and 50% in with an inclusion period of 24 months and alpha=5% warants a 90% power using a cox model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Coronary stent+optimal medical therapy | Experimental | Device: Stent, Drug: optimal medical therapyCoronary stent on top of optimal medical therapy |
| 2: Optimal medical therapy | Active comparator | Drug: optimal medical therapyOptimal medical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients ≥ 18 years old
- Heart transplant recipient
- Stable clinical situation
- One or several non-critical coronary stenoses (≥ 50% et ≤ 75% visually or QCA-assessed diameter stenosis) considered as adequate for coronary stenting by the operator
- Left ventricular ejection fraction ≥ 40%
Key exclusion criteria (12 listed)
- Acute coronary syndrome
- In-stent restenosis
- Proof of an extensive myocardial ischemia (≥ 7/17 segments ASE model)
- Coronary stenosis considered as critical by the operators with slow flow
- ACC/AHA Class IA indication for revascularization :
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 |
|---|---|---|
| StentAlso: Any type of approved bare metal or drug-eluting coronary stentCoronary revascularization | Device | 1: Coronary stent+optimal medical therapy |
| optimal medical therapyAlso: Any treatment required at the physicians discretion for the treatment of the patientDual antiplatelet therapy: aspirin and a P2Y12 inhibitor as indicated | Drug | 1: Coronary stent+optimal medical therapy, 2: Optimal medical therapy |
Primary outcome
The composit of death, myocardial infarction, retransplantation, implantation of transitory or definitive ventricular assist devices, new or worsening heart failure, graft failure and/or a decrease of left ventricular ejection fraction of at least 25%
Time frame: at 1 year
The composit of death, myocardial infarction, retransplantation, implantation of transitory or definitive ventricular assist devices, new or worsening heart failure, graft failure and/or a decrease of left ventricular ejection fraction of at least 25% at 1 year
6 secondary outcomes
Death at 1 year
Time frame: at 1 year
myocardial infarction at 1 year
Time frame: at 1 year
Retransplantation at 1 year
Time frame: at 1 year
implantation of transitory or definitive ventricular assist devices at 1 year
Time frame: at 1 year
new or worsening heart failure at 1 year
Time frame: at 1 year
graft failure and/or a decrease of left ventricular ejection fraction of at least 25% at 1 year compared to baseline
Time frame: at 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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.
Farzin BEYGUI, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
Pascal LEPRINCE, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Saida VARNOUS, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stent and optimal medical therapy in people with Heart-lung Transplant Rejection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 14 Oct 2015. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composit of death, myocardial infarction, retransplantation, implantation of transitory or definitive ventricular assist devices, new or worsening heart failure, graft failure and/or a decrease of left ventricular ejection fraction of at least 25% (time frame: at 1 year). 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 14 Oct 2015.