Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD. (CompareAcute)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Maasstad Hospital
Sponsor:
Collaborators:
Abbott Vascular
St. Jude Medical
Information provided by (Responsible Party):
Maasstad Hospital
ClinicalTrials.gov Identifier:
NCT01399736
First received: July 20, 2011
Last updated: August 14, 2014
Last verified: August 2014

July 20, 2011
August 14, 2014
July 2011
January 2017   (final data collection date for primary outcome measure)
Composite endpoint of MACCE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Cerebrovascular Events (MACCE) at 12 months between groups
Composite endpoint of MACCE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Cerebrovascular Events (MACCE) at 12 months between groups ( a+b versus c-f).
Complete list of historical versions of study NCT01399736 on ClinicalTrials.gov Archive Site
  • Primary endpoint in subgroups [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    Primary endpoint rates at 12, 24 and 36 months in the subgroup of patients receiving staged or acute PCI treatment for FFR positive lesions in the non-IRA vs the subgroup of patients with FFR positive lesion that received optimal medical treatment.
  • Primary endpoint in subgroups [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    Primary endpoint rates at 12, 24 and 36 months in the subgroup of patients receiving acute PCI treatment for FFR positive lesions in the non-IRA vs the subgroup of patients receiving staged PCI treatment for FFR positive lesions in the non-IRA
  • Primary endpoint in subgroups [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    Primary endpoint rates at 12, 24 and 36 months in the subgroup of patients receiving staged PCI treatment for FFR negative lesions in the non-IRA vs the subgroup of patients not receiving PCI treatment for FFR negative lesions in the non-IRA.
  • Composite endpoint of NACE [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 12, 24 and 36 months (NACE i.e. Net Adverse Clinical Events)
  • Composite endpoint hospitalisation HF and UAP [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    A composite of hospitalisation for heart failure and unstable angina pectoris at 12, 24 and 36 months
  • All cause mortality and MI [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    All cause mortality or Myocardial infarction at 12, 24 and 36 months
  • Revascularisation [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]
    Any revascularisation at 12, 24 and 36 months
  • Stent thrombosis [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    Stent thrombosis at 12, 24 and 36 months
  • Bleeding [ Time Frame: 48 hour and 12 months ] [ Designated as safety issue: Yes ]
    Bleeding at 48 hr and 12 months
  • Treatment costs [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]
    Treatment costs 12, 24 and 36 months
  • Primary endpoint at 24 and 36 [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    Primary endpoint at 24 and 36 months as well as outcomes of each component of the primary endpoint at 12, 24 and 36 months.
  • Primary endpoint in subgroups [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    Primary endpoint rates at 12, 24 and 36 months in the subgroup of patients receiving staged or acute PCI treatment for FFR positive lesions in the non-IRA vs the subgroup of patients with FFR positive lesion that received optimal medical treatment. {figure 2, subgroups (a+c) vs subgroup d}
  • Primary endpoint in subgroups [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    Primary endpoint rates at 12, 24 and 36 months in the subgroup of patients receiving acute PCI treatment for FFR positive lesions in the non-IRA vs the subgroup of patients receiving staged PCI treatment for FFR positive lesions in the non-IRA (figure 2 subgroups a vs c)
  • Primary endpoint in subgroups [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    Primary endpoint rates at 12, 24 and 36 months in the subgroup of patients receiving staged PCI treatment for FFR negative lesions in the non-IRA vs the subgroup of patients not receiving PCI treatment for FFR negative lesions in the non-IRA. ( figure 2 subgroups e vs b+ f)
  • Composite endpoint of NACE [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 12, 24 and 36 months (NACE i.e. Net Adverse Clinical Events)
  • Composite endpoint hospitalisation HF and UAP [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    A composite of hospitalisation for heart failure and unstable angina pectoris at 12 months
  • Medium arterial blood pressure [ Time Frame: 5 min ] [ Designated as safety issue: No ]
    Medium of the arterial blood pressure difference before and 5 min after non culprit PCI
  • All cause mortality and MI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    All cause mortality or Myocardial infarction at 12 months
  • Revascularisation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Any revascularisation at 12 months
  • Stent thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Stent thrombosis at 12 months
  • Bleeding [ Time Frame: 48 hour and 12 months ] [ Designated as safety issue: Yes ]
    Bleeding at 48 hr and 12 months
  • Treatment costs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Treatment costs 12 months
Not Provided
Not Provided
 
Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD.
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.

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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Myocardial Infarction
  • Multivessel Coronary Artery Disease
  • Procedure: FFR-guided revascularisation strategy
    FFR-guided revascularisation strategy
  • Procedure: randomised to guidelines group
    Staged revascularisation by proven ischemia or persistence of symptoms of angina
  • Active Comparator: FFR-guided revascularisation strategy
    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.
    Intervention: Procedure: FFR-guided revascularisation strategy
  • Placebo Comparator: randomised to guidelines group
    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).
    Intervention: Procedure: randomised to guidelines group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
885
January 2019
January 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. Left main stem disease (stenosis > 50%)
  2. STEMI due to in-stent thrombosis
  3. Chronic total occlusion of a non-IRA
  4. Severe stenosis with TIMI flow ≤ II of the non-IRA artery.
  5. Non-IRA stenosis not amenable for PCI treatment (operators decision)
  6. Complicated IRA treatment, with one or more of the following;

    • Extravasation,
    • Permanent no re-flow after IRA treatment (TIMI flow 0-1),
    • Inability to implant a stent
  7. Known severe cardiac valve dysfunction that will require surgery in the follow-up period.
  8. Killip class III or IV already at presentation or at the completion of culprit lesion treatment.
  9. Life expectancy of < 2 years.
  10. Intolerance to Aspirin, Clopidogrel, Plasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus and known true anaphylaxis to prior contrast media of bleeding diathesis or known coagulopathy.
  11. Gastrointestinal or genitourinary bleeding within the prior 3 months,
  12. Planned elective surgical procedure necessitating interruption of thienopyridines during the first 6 months post enrolment.
  13. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  14. Pregnancy or planning to become pregnant any time after enrolment into this study.
  15. Inability to obtain informed consent.
  16. Expected lost to follow-up.
Both
18 Years to 85 Years
No
Contact: Peter Smits, MD, PHD +31102913322 smitsp@maasstadziekenhuis.nl
Contact: Ria van Vliet +31102913278 VlietM@maasstadziekenhuis.nl
Czech Republic,   Germany,   Hungary,   Luxembourg,   Netherlands,   Norway,   Poland,   Singapore,   Sweden
 
NCT01399736
Compare-Acute
Yes
Maasstad Hospital
Maasstad Hospital
  • Abbott Vascular
  • St. Jude Medical
Principal Investigator: Peter Smits, MD. PHD Maastadhospital / MCR
Study Chair: Elmir Omerovic, MD PhD Sahlgrenska Hospital Götheborg
Study Chair: Gert Richardt, MD PhD Herzzentrum Segeberger Kliniken
Study Chair: Franz-Josef Neumann, MD PhD Herz-Zentrum Bad Krozingen
Maasstad Hospital
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP