ST-elevation Myocardial InfarctionPRIMACYNCT01542385
Primary Reperfusion Secondary Stenting Trial
A study testing Stent in people with ST-elevation Myocardial Infarction, run by Montreal Heart Institute at 16 sites in 2 countries.
Trial summary
The purpose of this research project is to improve how we treat heart attacks. The study will assess whether it might not be better to wait a few hours before implanting the coronary stent into the coronary artery rather than implanting it immediately, in order to allow the drugs to completely dissolve the clot. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ST-elevation Myocardial Infarction
- What is being tested?
- Stent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Apr 2014to Aug 2019
- Phase
- Interventional
- 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
- Age between 18 and 80 years;
- STEMI, presenting within 12 hours of symptoms onset, and persisting for more than 20 minutes;
- ECG that fulfills any of the following criteria: ≥ 2 mm ST elevation in two anterior or lateral leads; or ≥ 1 mm ST elevation in two inferior leads; or new left bundle branch block (LBBB) with at least 1 mm concordant ST elevation;
- Infarct-related artery with TIMI flow 0 or 1 at baseline angiogram;
- Successful reperfusion (TIMI 2-3 flow), either spontaneously or after wire passage, thrombectomy, small size (≤ 2.0mm) angioplasty catheter, and persisting for more than 10 minutes;
- Infarct related artery with a diameter above 2.5 mm.
Who cannot join
- Prior STEMI in the qualifying coronary artery;
- Coronary dissection following reperfusion;
- STEMI caused by acute stent thrombosis or a venous or arterial bypass graft occlusion;
- Significant left main disease, as determined by angiography (≥ 50%) or other imaging technologies;
- Cardiac condition requiring emergent or urgent surgical repair;
- Failed thrombolysis and rescue PCI;
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- High risk of bleeding;
- Contraindication to either ticagrelor or GpIIb/IIIa inhibitors;
- STEMI with Killip III-IV or cardiogenic shock or presenting as sudden death, ventricular fibrillation, or sustained ventricular tachycardia;
- Women who are pregnant or breastfeeding;
- Creatinine clearance < 20 ml/min;
- Other contraindication to PCI;
- Participation with another investigational drug or investigational device study within 30 days prior to randomization (participation to registries is allowed);
- Any condition that in the opinion of the investigator would preclude compliance with the study protocol.
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
France11 sites
CH de Bastia
Bastia, 20200
CH de Cannes
Cannes, 06401
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Hôpital Louis-Pasteur
Le Coudray, 28360
HCL Hopital Croix Rousse
Lyon, 69317
CH Annecy Genevois
Metz-Tessy, 74370
Ch de Montpellier-Hôpital A. de Villneuve
Montpellier, 34295
CH de Nimes
Nîmes, 30029
CH de Pau
Pau, 64000
CHU de Toulouse-Hôpital Rangueil
Toulouse, 31059
CH de Vichy
Vichy, 03200
Canada5 sites
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
CHUM-Hôtel-Dieu de Montréal
Montreal, Quebec, H2W 1T8
Hôpital du Sacré Cœur de Montréal
Montreal, Quebec, H4J 1C5
Centre Hospitalier Régional de Lanaudière
Saint-Charles-Borromée, Quebec, J6E 6J2
CHR CSSS de Trois Rivières
Trois-Rivières, Quebec, G8Z 3R9
About this study
Official title: Immediate vs. Delayed Stenting After Primary Percutaneous Reperfusion in ST Elevation Myocardial Infarction
The purpose of this research project is to improve how we treat heart attacks. The study will assess whether it might not be better to wait a few hours before implanting the coronary stent into the coronary artery rather than implanting it immediately, in order to allow the drugs to completely dissolve the clot. This might help to reduce the risks of the clot migrating and damaging the heart. By delaying coronary stent implantation, we hope to be able to reduce the size of the infarction and reduce the risk of suffering from heart failure following a heart attack.
Read the detailed description
The PRIMACY trial seeks to assess whether a strategy of delayed stent implantation combined with adjunctive anticoagulation is superior to immediate stent implantation at improving cardiovascular outcomes in patients with mechanically reperfused ST-elevation Myocardial Infarction (STEMI). The investigators hypothesize that delayed stent implantation combined with systemic anticoagulation and maximal antiplatelet therapy will reduce the combined occurrence of cardiac death, non-fatal myocardial infarction, congestive heart failure, or unplanned target vessel revascularization over a 9-month period.
- Conditions
- ST-elevation Myocardial Infarction
- Being tested
- Stent
- Keywords
- Delayed stenting, Deferred stenting, Late stenting, postponed stenting, Thrombectomy, Percutaneous coronary intervention, PCI, Angioplasty, STEMI, acute myocardial infarction
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StentProcedure or surgery
Also called Thrombectomy catheter, Balloon angioplasty catheter, Coronary stent
Percutaneous coronary intervention: reperfusion with a thrombectomy catheter or a small balloon angioplasty catheter, followed by coronary stenting
| Study group | Role | What they receive |
|---|---|---|
| Immediate stenting | Active comparator | the stent selection (bare metal vs drug eluting) and implantation will be performed as recommended by current practice guidelines. Receives: Procedure: Stent |
| Delayed stenting | Experimental | participants randomised to delayed stenting will be treated with GPIIb-IIIa inhibitors for 12-18 hours after reperfusion followed by anticoagulation for until the control angiogram, expected no sooner than 18-24 hours after the index reperfusion. Receives: Procedure: Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
The combined occurence of cardiac death, non-fatal myocardial infarction, congestive heart failure, and urgent target vessel revascularization
As defined by standardized definitions
Measured: 9 months
Secondary outcomes (1)
Major bleeding
As defined by the Bleeding Academic Research Consortium (BARC).
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startApr 2014
- Primary completionMay 2018
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-elevation 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
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Jolicoeur, Montreal Heart Institute
- Investigators
- Marc E Jolicoeur, MD MSc MHS, Study chair, Montreal Heart Institute, Université de MontréalNandini Dendukuri, PhD, Study director, Centre for Outcomes Research, McGill University Health Centre - Research InstituteLoic Belle, MD, Study director, Hospital of Annecy, Centre Hospitalier Annecy Genevois, Annecy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542385
- Sponsor's protocol ID
- PRIMACY
- Acronym
- PRIMACY
- Status last verified
- Aug 2020
- First submitted
- 16 Feb 2012
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate vs. Delayed Stenting After Primary Percutaneous Reperfusion in ST Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01542385
- Acronym / sponsor ID
- PRIMACY / PRIMACY
- Conditions
- ST-elevation Myocardial Infarction
- Keywords
- Delayed stenting, Deferred stenting, Late stenting, postponed stenting, Thrombectomy, Percutaneous coronary intervention, PCI, Angioplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2018 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 2 Mar 2012 (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 purpose of this research project is to improve how we treat heart attacks. The study will assess whether it might not be better to wait a few hours before implanting the coronary stent into the coronary artery rather than implanting it immediately, in order to allow the drugs to completely dissolve the clot. This might help to reduce the risks of the clot migrating and damaging the heart. By delaying coronary stent implantation, we hope to be able to reduce the size of the infarction and reduce the risk of suffering from heart failure following a heart attack.
Detailed description
The PRIMACY trial seeks to assess whether a strategy of delayed stent implantation combined with adjunctive anticoagulation is superior to immediate stent implantation at improving cardiovascular outcomes in patients with mechanically reperfused ST-elevation Myocardial Infarction (STEMI). The investigators hypothesize that delayed stent implantation combined with systemic anticoagulation and maximal antiplatelet therapy will reduce the combined occurrence of cardiac death, non-fatal myocardial infarction, congestive heart failure, or unplanned target vessel revascularization over a 9-month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate stenting | Active comparator | Procedure: Stentthe stent selection (bare metal vs drug eluting) and implantation will be performed as recommended by current practice guidelines. |
| Delayed stenting | Experimental | Procedure: Stentparticipants randomised to delayed stenting will be treated with GPIIb-IIIa inhibitors for 12-18 hours after reperfusion followed by anticoagulation for until the control angiogram, expected no sooner than 18-24 hours after the index reperfusion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 80 years;
- STEMI, presenting within 12 hours of symptoms onset, and persisting for more than 20 minutes;
- ECG that fulfills any of the following criteria: ≥ 2 mm ST elevation in two anterior or lateral leads; or ≥ 1 mm ST elevation in two inferior leads; or new left bundle branch block (LBBB) with at least 1 mm concordant ST elevation;
- Infarct-related artery with TIMI flow 0 or 1 at baseline angiogram;
- Successful reperfusion (TIMI 2-3 flow), either spontaneously or after wire passage, thrombectomy, small size (≤ 2.0mm) angioplasty catheter, and persisting for more than 10 minutes;
Key exclusion criteria (14 listed)
- Prior STEMI in the qualifying coronary artery;
- Coronary dissection following reperfusion;
- STEMI caused by acute stent thrombosis or a venous or arterial bypass graft occlusion;
- Significant left main disease, as determined by angiography (≥ 50%) or other imaging technologies;
- Cardiac condition requiring emergent or urgent surgical repair;
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: Thrombectomy catheter, Balloon angioplasty catheter, Coronary stentPercutaneous coronary intervention: reperfusion with a thrombectomy catheter or a small balloon angioplasty catheter, followed by coronary stenting | Procedure or surgery | Delayed stenting, Immediate stenting |
Primary outcome
The combined occurence of cardiac death, non-fatal myocardial infarction, congestive heart failure, and urgent target vessel revascularization
Time frame: 9 months
As defined by standardized definitions
1 secondary outcome
Major bleeding
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Canadian Journal of Cardiology EditorialLink provided by the sponsor.
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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.
Marc E Jolicoeur, MD MSc MHS study chair
Montreal Heart Institute, Université de Montréal
Nandini Dendukuri, PhD study director
Centre for Outcomes Research, McGill University Health Centre - Research Institute
Loic Belle, MD study director
Hospital of Annecy, Centre Hospitalier Annecy Genevois, Annecy, France
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent in people with ST-elevation Myocardial Infarction, run by Montreal Heart Institute at 16 sites in 2 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 6 inclusion and 14 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 5 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 16 sites in France, Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 combined occurence of cardiac death, non-fatal myocardial infarction, congestive heart failure, and urgent target vessel revascularization (time frame: 9 months). 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 5 Aug 2020.