Clinical trial NCT01542385: Primary Reperfusion Secondary Stenting Trial
Official title: Immediate vs. Delayed Stenting After Primary Percutaneous Reperfusion in ST Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ST-elevation Myocardial Infarction
Keywords: Delayed stenting
Deferred stenting
Late stenting
postponed stenting
Thrombectomy
Percutaneous coronary intervention
PCI
Angioplasty
STEMI
acute myocardial infarction
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 80 years;
2. STEMI, presenting within 12 hours of symptoms onset, and persisting for more than 20 minutes;
3. 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;
4. Infarct-related artery with TIMI flow 0 or 1 at baseline angiogram;
5. 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;
6. Infarct related artery with a diameter above 2.5 mm.

Exclusion Criteria:

1. Prior STEMI in the qualifying coronary artery;
2. Coronary dissection following reperfusion;
3. STEMI caused by acute stent thrombosis or a venous or arterial bypass graft occlusion;
4. Significant left main disease, as determined by angiography (≥ 50%) or other imaging technologies;
5. Cardiac condition requiring emergent or urgent surgical repair;
6. Failed thrombolysis and rescue PCI;
7. High risk of bleeding;
8. Contraindication to either ticagrelor or GpIIb/IIIa inhibitors;
9. STEMI with Killip III-IV or cardiogenic shock or presenting as sudden death, ventricular fibrillation, or sustained ventricular tachycardia;
10. Women who are pregnant or breastfeeding;
11. Creatinine clearance \< 20 ml/min;
12. Other contraindication to PCI;
13. Participation with another investigational drug or investigational device study within 30 days prior to randomization (participation to registries is allowed);
14. Any condition that in the opinion of the investigator would preclude compliance with the study protocol.

Primary outcomes:
measure: The combined occurence of cardiac death, non-fatal myocardial infarction, congestive heart failure, and urgent target vessel revascularization
timeFrame: 9 months
Secondary outcomes:
measure: Major bleeding
timeFrame: 9 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: CHUM-Hôtel-Dieu de Montréal
state: Quebec
city: Montreal
country: Canada
facility: Hôpital du Sacré Cœur de Montréal
state: Quebec
city: St-Charles-Borromée
country: Canada
facility: Centre Hospitalier Régional de Lanaudière
state: Quebec
city: Trois Rivières
country: Canada
facility: CHR CSSS de Trois Rivières
state: Quebec
city: Bastia
country: France
facility: CH de Bastia
city: Cannes
country: France
facility: CH de Cannes
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Le Coudray
country: France
facility: Hôpital Louis-Pasteur
city: Lyon
country: France
facility: HCL Hopital Croix Rousse
city: Metz-Tessy
country: France
facility: CH Annecy Genevois
city: Montpellier
country: France
facility: Ch de Montpellier-Hôpital A. de Villneuve
city: Nimes
country: France
facility: CH de Nimes
city: Pau
country: France
facility: CH de Pau
city: Toulouse
country: France
facility: CHU de Toulouse-Hôpital Rangueil
city: Vichy
country: France
facility: CH de Vichy
Study officials:
affiliation: Montreal Heart Institute, Université de Montréal
name: Marc E Jolicoeur, MD MSc MHS
role: STUDY_CHAIR
affiliation: Centre for Outcomes Research, McGill University Health Centre - Research Institute
name: Nandini Dendukuri, PhD
role: STUDY_DIRECTOR
affiliation: Hospital of Annecy, Centre Hospitalier Annecy Genevois, Annecy, France
name: Loic Belle, MD
role: STUDY_DIRECTOR
References: