Primary Reperfusion Secondary Stenting Trial

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
Immediate vs. Delayed Stenting After Primary Percutaneous Reperfusion in ST Elevation Myocardial Infarction

Conditions
-----------------
ST-elevation Myocardial Infarction

Intervention / Treatment
-----------------
* Procedure: Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate stenting<br>the stent selection (bare metal vs drug eluting) and implantation will be performed as recommended by current practice guidelines. | Procedure: Stent<br>* Percutaneous coronary intervention: reperfusion with a thrombectomy catheter or a small balloon angioplasty catheter, followed by coronary stenting<br>* Other names: Coronary stent;|
| Experimental: Delayed stenting<br>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. | Procedure: Stent<br>* Percutaneous coronary intervention: reperfusion with a thrombectomy catheter or a small balloon angioplasty catheter, followed by coronary stenting<br>* Other names: Coronary stent;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major bleeding | As defined by the Bleeding Academic Research Consortium (BARC). | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delayed stenting, Deferred stenting, Late stenting, postponed stenting, Thrombectomy, Percutaneous coronary intervention, PCI, Angioplasty, STEMI, acute myocardial infarction