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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate stenting | Active Comparator | the stent selection (bare metal vs drug eluting) and implantation will be performed as recommended by current practice guidelines. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent | Procedure | Percutaneous coronary intervention: reperfusion with a thrombectomy catheter or a small balloon angioplasty catheter, followed by coronary stenting |
|
| Measure | Description | Time Frame |
|---|---|---|
| The combined occurence of cardiac death, non-fatal myocardial infarction, congestive heart failure, and urgent target vessel revascularization | As defined by standardized definitions | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding | As defined by the Bleeding Academic Research Consortium (BARC). | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc E Jolicoeur, MD MSc MHS | Montreal Heart Institute, Université de Montréal | Study Chair |
| Nandini Dendukuri, PhD | Centre for Outcomes Research, McGill University Health Centre - Research Institute | Study Director |
| Loic Belle, MD | Hospital of Annecy, Centre Hospitalier Annecy Genevois, Annecy, France | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada | ||
| CHUM-Hôtel-Dieu de Montréal |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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|
| Montreal |
| Quebec |
| H2W 1T8 |
| Canada |
| Hôpital du Sacré Cœur de Montréal | Montreal | Quebec | H4J 1C5 | Canada |
| Centre Hospitalier Régional de Lanaudière | Saint-Charles-Borromée | Quebec | J6E 6J2 | Canada |
| CHR CSSS de Trois Rivières | Trois-Rivières | Quebec | G8Z 3R9 | Canada |
| CH de Bastia | Bastia | 20200 | France |
| CH de Cannes | Cannes | 06401 | France |
| CHU de Clermont-Ferrand | Clermont-Ferrand | 63000 | France |
| Hôpital Louis-Pasteur | Le Coudray | 28360 | France |
| HCL Hopital Croix Rousse | Lyon | 69317 | France |
| CH Annecy Genevois | Metz-Tessy | 74370 | France |
| Ch de Montpellier-Hôpital A. de Villneuve | Montpellier | 34295 | France |
| CH de Nimes | Nîmes | 30029 | France |
| CH de Pau | Pau | 64000 | France |
| CHU de Toulouse-Hôpital Rangueil | Toulouse | 31059 | France |
| CH de Vichy | Vichy | 03200 | France |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |