Myocardial InfarctionCompareAcuteNCT01399736
Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD.
A study testing FFR-guided revascularisation strategy and randomised to guidelines group in people with Myocardial Infarction and Multivessel Coronary Artery Disease, run by Maasstad Hospital at 26 sites in 8 countries.
Trial summary
The Compare-Acute trial is a prospective randomised trial in patients with multivessel disease, who are admitted into hospital with a ST-elevation Myocardial Infarction. The purpose of the study is to compare a FFR guided multivessel PCI taking place during the primary PCI with a primary PCI of the culprit vessel… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myocardial Infarction, Multivessel Coronary Artery Disease
- What is being tested?
- FFR-guided revascularisation strategy and randomised to guidelines group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 885 participants
- Where
- 26 sitesin 8 countries
- Study dates
- Jul 2011to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients between 18-85 years presenting with STEMI who will be treated with primary PCI in < 12 h after the onset of symptoms* and have at least one stenosis of >50% in a non-IRA on QCA or visual estimation of baseline angiography and judged feasible for treatment with PCI by the operator.
- Patients with symptoms for more than 12 hr but ongoing angina complaints can be randomised
Who cannot join
- Left main stem disease (stenosis > 50%)
- STEMI due to in-stent thrombosis
- Chronic total occlusion of a non-IRA
- Severe stenosis with TIMI flow ≤ II of the non-IRA artery.
- Non-IRA stenosis not amenable for PCI treatment (operators decision)
- Complicated IRA treatment, with one or more of the following;
Show all 19Show fewer
- Extravasation,
- Permanent no re-flow after IRA treatment (TIMI flow 0-1),
- Inability to implant a stent
- Known severe cardiac valve dysfunction that will require surgery in the follow-up period.
- Killip class III or IV already at presentation or at the completion of culprit lesion treatment.
- Life expectancy of < 2 years.
- Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus and known true anaphylaxis to prior contrast media of bleeding diathesis or known coagulopathy.
- Gastrointestinal or genitourinary bleeding within the prior 3 months,
- Planned elective surgical procedure necessitating interruption of thienopyridines during the first 6 months post enrolment.
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- Pregnancy or planning to become pregnant any time after enrolment into this study.
- Inability to obtain informed consent.
- Expected lost to follow-up.
Trial locations and contacts
26 sites in 8 countries.
26 sites in 8 countries
Netherlands6 sites
Rijnstate Hospital
Arnhem
University Medical Center Groningen
Groningen
Atrium MC Parkstad
Heerlen
Maastricht Universitair Medical center
Maastricht
Maasstadhospital
Rotterdam, 3079DZ
Medisch Centrum Haaglanden
The Hague, 2512 VA
Germany5 sites
Herz-Zentrum Bad Krozingen
Bad Krozingen, 79189
Herzzentrum Bad Segeberger Klinik
Bad Segeberg, 23795
Klinikum Links der Weser
Bremen, 28277
Medizinische Klinik IV
Ingolstadt, 85049
Medical University Rostock
Rostock, 18057
Hungary4 sites
Gottsegen György Országos Kardiológiai Intézet
Budapest
Szabolcs - Szatmár - Bereg County Hospitals and University Teaching Hospital
Nyíregyháza
Szent-Györgyi Albert Klinika
Szeged
Zala Megyei Korhaz
Zalaegerszeg
Poland4 sites
Miedziowe Centrum Zdrowia Lubin
Lubin
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw
Kliniki Kardiologii Allenort
Warsaw
4 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
Wroclaw
Czechia3 sites
University Hospital BRNO
Brno
University Hospital Hradec Králové
Hradec Králové
Liberec Regional Hospital
Liberec
Singapore2 sites
Tan Tock Seng Hospital
Singapore, 308433
Khoo Teck Puat Hospital
Singapore, 768828
About this study
Official title: Fractional Flow Reserve Guided Primary Multivessel Percutaneous Coronary Intervention to Improve Guideline Indexed Actual Standard of Care for Treatment of ST-elevation Myocardial Infarction in Patients With Multivessel Coronary Disease
The Compare-Acute trial is a prospective randomised trial in patients with multivessel disease, who are admitted into hospital with a ST-elevation Myocardial Infarction. The purpose of the study is to compare a FFR guided multivessel PCI taking place during the primary PCI with a primary PCI of the culprit vessel only.
Patients will be enrolled after successful revascularisation of the culprit vessel. Patients that have at least one lesion with a diameter of stenosis of more than 50% on visual estimation, feasible (operators judgement) for treatment with PCI in a non-infarct related artery, will be randomised either to the FFR guided complete revascularisation arm or staged revascularisation by proven ischemia or persistence of symptoms of angina.
Read more
Approximately 885 patients will be entered in the study.
Study hypothesis: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines.
Read the detailed description
Background of the study: At the moment the general opinion is divided over the way the non culprit lesions in patients presenting with STEMI should be treated. While the previous guidelines stead that these lesions should be treated in a second time ( ie not during the primary intervention) the actual guidelines do not touch this argument. The reason is that the studies where the previous guidelines were based are old. Meanwhile small sized randomised trials from EU region have proven favourable outcomes with NON infarct related artery during the primary procedure while registers (non randomised trials) from USA still recommend the staged treatment. For this reason we have decided to perform a randomised study to address this issue incorporating the state of the art diagnosis and treatment, as well as the new medical therapy and PCI techniques.
Objective of the study: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines
Study design: Prospective, 1: 2 randomisation. FFR guided revascularisation during primary PCI (1) versus following actual guidelines (2)
Study population: All STEMI patients between 18-85 years who will be treated with primary PCI in < 12 h (more than 12 hr if persisting pain allowed) after the onset of symptoms and have at least one stenosis of >50% in a non-IRA judged feasible for treatment with PCI.
Intervention (if applicable): FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines
Primary study parameters/outcome of the study: Composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Stroke (MACCE) at 12 months
- Being tested
- FFR-guided revascularisation strategy, randomised to guidelines group
- Keywords
- PCI FFR STEMI MVD, FFR guided PCI in acute STEMI patients with MVD
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFR-guided revascularisation strategyProcedure or surgery
FFR-guided revascularisation strategy
randomised to guidelines groupProcedure or surgery
Staged revascularisation by proven ischemia or persistence of symptoms of angina
| Study group | Role | What they receive |
|---|---|---|
| FFR-guided revascularisation strategy | Active comparator | In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. Receives: Procedure: FFR-guided revascularisation strategy |
| randomised to guidelines group | Placebo comparator | In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). Receives: Procedure: randomised to guidelines group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With the Composite Endpoint of MACCE
Number of participants with the composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Cerebrovascular Events (MACCE) at 12 months between groups
Measured: 12 months
Number of Participants With Death From Any Cause
Number of participants with all cause mortality at 12 months between groups
Measured: 12 months
Number of Participants With Cardiac Death
Number of participants with Cardiac mortality at 12 months between groups
Measured: 12 months
Number of Participants With Spontaneous MI
Number of participants with Spontaneous Myocardial Infarction at 12 months between groups
Measured: 12 months
Number of Participants With Periprocedural MI
Number of participants with Periprocedural Myocardial Infarction at 12 months between groups
Measured: 12 months
Number of Participants With Revascularization - PCI
Number of participants with revascularization PCI at 12 months between groups
Measured: 12 months
Number of Participants With Revascularization - CABG
Number of participants with revascularization CABG at 12 months between groups
Measured: 12 months
Number of Participants With Cerebrovascular Event
Number of participants with Cerebrovascular event at 12 months between groups
Measured: 12 months
Secondary outcomes (23)
Number of Participants With Composite Endpoint of NACE (Any First Event)
Number of participants with Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 12 months (NACE i.e. Net Adverse Clinical Events)
Measured: 12 months
Number of Participants With Death From Any Cause or MI
Number of participants with Part of composite NACE-Death from any cause or Myocardial Infarction at 12 months
Measured: 12 months
Number of Participants With Major Bleeding
Number of participants with Major bleeding at 12 months - Part of composite NACE
Measured: 12 months
Number of Participants With Any Bleeding at 12 Months
Number of participants with any bleeding at 12 months - part of composite endpoint NACE
Measured: 12 months
Number of Participants With Any Bleeding at 48 Hours
Number of participants with any bleeding at 48 hours - part of composite endpoint NACE
Measured: 48 hours
Number of Participants With Hospitalization
Number of participants with hospitalization for heart failure, unstable angina or chest pain
Measured: 12 months
Number of Participants With Revascularization
Number of participants with any revascularization-Part of composite endpoint NACE
Measured: 12 months
Number of Participants With Stent Thrombosis
Number of participants with Stent Thrombosis - Part of composite endpoint NACE
Measured: 12 months
Number of Participants With Primary Endpoint Outcome MACCE (Any First Event) at 3 Year
Number of participants with Composite primary endpoint MACCE (any first event) at 3 year
Measured: 3 year
Number of Participants With All Cause Death at 3 Year
Number of participants with Composite endpoint MACCE (any first event) at 3 year - all cause death
Measured: 3 year
Number of Participants With Cardiac Death at 3 Year
Number of participants with Composite endpoint MACCE (any first event) at 3 year - Cardiac death
Measured: 3 year
Number of Participants With Spontaneous MI at 3 Year
Number of participants with Composite endpoint MACCE (any first event) at 3 year - Spontaneous MI
Measured: 3 year
Number of Participants With Peri-procedural MI at 3 Year
Number of participants with Composite endpoint MACCE (any first event) at 3 year - Peri-procedural MI
Measured: 3 year
Number of Participants With Urgent Revascularization at 3 Year
Number of participants with Composite endpoint MACCE (any first event) at 3 year - urgent revascularisation
Measured: 3 year
Number of Participants With Elective Revascularization at 3 Year
Number of participants with Composite endpoint MACCE (any first event) at 3 year -elective revascularisation
Measured: 3 year
Number of Participants With Cerebrovascular Event
Number of participants with Composite endpoint MACCE (any first event) at 3 year -Cerebrovascular event
Measured: 3 year
Number of Participants With Composite Endpoint of NACE (Any First Event) at 3 Year
Number of participants with Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 3 year (NACE i.e. Net Adverse Clinical Events)
Measured: 3 years
Number of Participants With Death From Any Cause or MI
Number of participants with Part of composite NACE-Death from any cause or Myocardial Infarction at 3 year
Measured: 3 year
Number of Participants With Major Bleeding at 3 Year
Number of participants with Part of composite endpoint NACE- Major bleeding at 3 year
Measured: 3 year
Number of Participants With Hospitalization
Number of participants with Hospitalization for heart failure, unstable angina, MI
Measured: 3 year
Number of Participants With Hospitalization at 3 Year
Number of participants with Hospitalization for heart failure, unstable angina, MI and/or chest pain
Measured: 3 year
Number of Participants With Stent Thrombosis at 3 Year
Number of participants with Stent Thrombosis at 3 year - Part of composite endpoint NACE
Measured: 3 year
Number of Participants With Any Bleeding at 3 Year
Number of participants with any bleeding at 3 year - Part of composite endpoint NACE
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startJul 2011
- Primary completion31 Oct 2016
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 885 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maasstad Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
- Investigators
- Peter Smits, MD. PHD, Principal investigator, Maastadhospital / MCRElmir Omerovic, MD PhD, Study chair, Sahlgrenska Hospital GötheborgGert Richardt, MD PhD, Study chair, Herzzentrum Segeberger KlinikenFranz-Josef Neumann, MD PhD, Study chair, Herz-Zentrum Bad Krozingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399736
- Sponsor's protocol ID
- Compare-Acute
- Acronym
- CompareAcute
- Status last verified
- May 2020
- First submitted
- 20 Jul 2011
- Last updated
- 11 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Piroth Z, Fulop G, Boxma-de Klerk BM, Abdelghani M, Omerovic E, Andreka P, Fontos G, Neumann FJ, Richardt G, Smits PC. Correlation and Relative Prognostic Value of Fractional Flow Reserve and Pd/Pa of Nonculprit Lesions in ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2022 Feb;15(2):e010796. doi: 10.1161/CIRCINTERVENTIONS.121.010796. Epub 2022 Jan 20.
PubMed 35045732Wang LJ, Han S, Zhang XH, Jin YZ. Fractional flow reserve-guided complete revascularization versus culprit-only revascularization in acute ST-segment elevation myocardial infarction and multi-vessel disease patients: a meta-analysis and systematic review. BMC Cardiovasc Disord. 2019 Mar 1;19(1):49. doi: 10.1186/s12872-019-1022-6.
PubMed 30823897Smits PC, Abdel-Wahab M, Neumann FJ, Boxma-de Klerk BM, Lunde K, Schotborgh CE, Piroth Z, Horak D, Wlodarczak A, Ong PJ, Hambrecht R, Angeras O, Richardt G, Omerovic E; Compare-Acute Investigators. Fractional Flow Reserve-Guided Multivessel Angioplasty in Myocardial Infarction. N Engl J Med. 2017 Mar 30;376(13):1234-1244. doi: 10.1056/NEJMoa1701067. Epub 2017 Mar 18.
PubMed 28317428
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Flow Reserve Guided Primary Multivessel Percutaneous Coronary Intervention to Improve Guideline Indexed Actual Standard of Care for Treatment of ST-elevation Myocardial Infarction in Patients With Multivessel Coronary Disease
- ClinicalTrials.gov ID
- NCT01399736
- Acronym / sponsor ID
- CompareAcute / Compare-Acute
- Keywords
- PCI FFR STEMI MVD, FFR guided PCI in acute STEMI patients with MVD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 885 participants (actual)
- Lead sponsor
- Maasstad HospitalUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Jul 2011
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Posted 23 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Compare-Acute trial is a prospective randomised trial in patients with multivessel disease, who are admitted into hospital with a ST-elevation Myocardial Infarction. The purpose of the study is to compare a FFR guided multivessel PCI taking place during the primary PCI with a primary PCI of the culprit vessel only.
Patients will be enrolled after successful revascularisation of the culprit vessel. Patients that have at least one lesion with a diameter of stenosis of more than 50% on visual estimation, feasible (operators judgement) for treatment with PCI in a non-infarct related artery, will be randomised either to the FFR guided complete revascularisation arm or staged revascularisation by proven ischemia or persistence of symptoms of angina.
Approximately 885 patients will be entered in the study.
Study hypothesis: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines.
Detailed description
Background of the study: At the moment the general opinion is divided over the way the non culprit lesions in patients presenting with STEMI should be treated. While the previous guidelines stead that these lesions should be treated in a second time ( ie not during the primary intervention) the actual guidelines do not touch this argument. The reason is that the studies where the previous guidelines were based are old. Meanwhile small sized randomised trials from EU region have proven favourable outcomes with NON infarct related artery during the primary procedure while registers (non randomised trials) from USA still recommend the staged treatment. For this reason we have decided to perform a randomised study to address this issue incorporating the state of the art diagnosis and treatment, as well as the new medical therapy and PCI techniques.
Objective of the study: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines
Study design: Prospective, 1: 2 randomisation. FFR guided revascularisation during primary PCI (1) versus following actual guidelines (2)
Study population: All STEMI patients between 18-85 years who will be treated with primary PCI in < 12 h (more than 12 hr if persisting pain allowed) after the onset of symptoms and have at least one stenosis of >50% in a non-IRA judged feasible for treatment with PCI.
Intervention (if applicable): FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines
Primary study parameters/outcome of the study: Composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Stroke (MACCE) at 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FFR-guided revascularisation strategy | Active comparator | Procedure: FFR-guided revascularisation strategyIn the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. |
| randomised to guidelines group | Placebo comparator | Procedure: randomised to guidelines groupIn the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients between 18-85 years presenting with STEMI who will be treated with primary PCI in < 12 h after the onset of symptoms* and have at least one stenosis of >50% in a non-IRA on QCA or visual estimation of baseline angiography and judged feasible for treatment with PCI by the operator.
Key exclusion criteria (19 listed)
- Left main stem disease (stenosis > 50%)
- STEMI due to in-stent thrombosis
- Chronic total occlusion of a non-IRA
- Severe stenosis with TIMI flow ≤ II of the non-IRA artery.
- Non-IRA stenosis not amenable for PCI treatment (operators decision)
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 |
|---|---|---|
| FFR-guided revascularisation strategyFFR-guided revascularisation strategy | Procedure or surgery | FFR-guided revascularisation strategy |
| randomised to guidelines groupStaged revascularisation by proven ischemia or persistence of symptoms of angina | Procedure or surgery | randomised to guidelines group |
Primary outcome
Number of Participants With the Composite Endpoint of MACCE
Time frame: 12 months
Number of participants with the composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Cerebrovascular Events (MACCE) at 12 months between groups
Number of Participants With Death From Any Cause
Time frame: 12 months
Number of participants with all cause mortality at 12 months between groups
Number of Participants With Cardiac Death
Time frame: 12 months
Number of participants with Cardiac mortality at 12 months between groups
Number of Participants With Spontaneous MI
Time frame: 12 months
Number of participants with Spontaneous Myocardial Infarction at 12 months between groups
Number of Participants With Periprocedural MI
Time frame: 12 months
Number of participants with Periprocedural Myocardial Infarction at 12 months between groups
Number of Participants With Revascularization - PCI
Time frame: 12 months
Number of participants with revascularization PCI at 12 months between groups
Number of Participants With Revascularization - CABG
Time frame: 12 months
Number of participants with revascularization CABG at 12 months between groups
Number of Participants With Cerebrovascular Event
Time frame: 12 months
Number of participants with Cerebrovascular event at 12 months between groups
23 secondary outcomes
Number of Participants With Composite Endpoint of NACE (Any First Event)
Time frame: 12 months
Number of Participants With Death From Any Cause or MI
Time frame: 12 months
Number of Participants With Major Bleeding
Time frame: 12 months
Number of Participants With Any Bleeding at 12 Months
Time frame: 12 months
Number of Participants With Any Bleeding at 48 Hours
Time frame: 48 hours
Number of Participants With Hospitalization
Time frame: 12 months
Number of Participants With Revascularization
Time frame: 12 months
Number of Participants With Stent Thrombosis
Time frame: 12 months
Number of Participants With Primary Endpoint Outcome MACCE (Any First Event) at 3 Year
Time frame: 3 year
Number of Participants With All Cause Death at 3 Year
Time frame: 3 year
Number of Participants With Cardiac Death at 3 Year
Time frame: 3 year
Number of Participants With Spontaneous MI at 3 Year
Time frame: 3 year
Number of Participants With Peri-procedural MI at 3 Year
Time frame: 3 year
Number of Participants With Urgent Revascularization at 3 Year
Time frame: 3 year
Number of Participants With Elective Revascularization at 3 Year
Time frame: 3 year
Number of Participants With Cerebrovascular Event
Time frame: 3 year
Number of Participants With Composite Endpoint of NACE (Any First Event) at 3 Year
Time frame: 3 years
Number of Participants With Death From Any Cause or MI
Time frame: 3 year
Number of Participants With Major Bleeding at 3 Year
Time frame: 3 year
Number of Participants With Hospitalization
Time frame: 3 year
Number of Participants With Hospitalization at 3 Year
Time frame: 3 year
Number of Participants With Stent Thrombosis at 3 Year
Time frame: 3 year
Number of Participants With Any Bleeding at 3 Year
Time frame: 3 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35045732Piroth Z, Fulop G, Boxma-de Klerk BM, Abdelghani M, Omerovic E, Andreka P, Fontos G, Neumann FJ, Richardt G, Smits PC. Correlation and Relative Prognostic Value of Fractional Flow Reserve and Pd/Pa of Nonculprit Lesions in ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2022 Feb;15(2):e010796. doi: 10.1161/CIRCINTERVENTIONS.121.010796. Epub 2022 Jan 20.
- Derived from this study: PubMed 30823897Wang LJ, Han S, Zhang XH, Jin YZ. Fractional flow reserve-guided complete revascularization versus culprit-only revascularization in acute ST-segment elevation myocardial infarction and multi-vessel disease patients: a meta-analysis and systematic review. BMC Cardiovasc Disord. 2019 Mar 1;19(1):49. doi: 10.1186/s12872-019-1022-6.
- Derived from this study: PubMed 28317428Smits PC, Abdel-Wahab M, Neumann FJ, Boxma-de Klerk BM, Lunde K, Schotborgh CE, Piroth Z, Horak D, Wlodarczak A, Ong PJ, Hambrecht R, Angeras O, Richardt G, Omerovic E; Compare-Acute Investigators. Fractional Flow Reserve-Guided Multivessel Angioplasty in Myocardial Infarction. N Engl J Med. 2017 Mar 30;376(13):1234-1244. doi: 10.1056/NEJMoa1701067. Epub 2017 Mar 18.
- Individual participant dataSharing planned: No
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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.
Peter Smits, MD. PHD principal investigator
Maastadhospital / MCR
Elmir Omerovic, MD PhD study chair
Sahlgrenska Hospital Götheborg
Gert Richardt, MD PhD study chair
Herzzentrum Segeberger Kliniken
26 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FFR-guided revascularisation strategy and randomised to guidelines group in people with Myocardial Infarction and Multivessel Coronary Artery Disease, run by Maasstad Hospital at 26 sites in 8 countries.
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 2 inclusion and 19 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: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Netherlands, Germany, Hungary, Poland, Czechia and 3 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With the Composite Endpoint of MACCE (time frame: 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01399736, which also lists 3 linked publications.
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 11 Aug 2020.