Primary Reperfusion Secondary Stenting Trial

Not Applicable

Completed

• Conditions: ST-elevation Myocardial Infarction
• Interventions: Procedure: Stent

• Registration Number: NCT01542385
• Lead Sponsor: Montreal Heart Institute

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.

Study Timeline

• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-02
• Study Start: 2014-04
• Primary Completion: 2018-05
• Study Completion: 2019-08
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate stenting	Stent	the stent selection (bare metal vs drug eluting) and implantation will be performed as recommended by current practice guidelines.
Delayed stenting	Stent	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.

Primary Outcome Measures

Name	Time	Method
The combined occurence of cardiac death, non-fatal myocardial infarction, congestive heart failure, and urgent target vessel revascularization	9 months	As defined by standardized definitions

Secondary Outcome Measures

Name	Time	Method
Major bleeding	9 months	As defined by the Bleeding Academic Research Consortium (BARC).

Trial Locations

Locations (16)

Hôpital du Sacré Cœur de Montréal; 🇨🇦 Montreal, Quebec, Canada

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada

CHUM-Hôtel-Dieu de Montréal; 🇨🇦 Montreal, Quebec, Canada

CH de Cannes; 🇫🇷 Cannes, France

Centre Hospitalier Régional de Lanaudière; 🇨🇦 St-Charles-Borromée, Quebec, Canada

CHR CSSS de Trois Rivières; 🇨🇦 Trois Rivières, Quebec, Canada

Ch de Montpellier-Hôpital A. de Villneuve; 🇫🇷 Montpellier, France

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU de Toulouse-Hôpital Rangueil; 🇫🇷 Toulouse, France

CH de Vichy; 🇫🇷 Vichy, France

CH de Bastia; 🇫🇷 Bastia, France

CH de Nimes; 🇫🇷 Nimes, France

CH Annecy Genevois; 🇫🇷 Metz-Tessy, France

HCL Hopital Croix Rousse; 🇫🇷 Lyon, France

Hôpital Louis-Pasteur; 🇫🇷 Le Coudray, France

CH de Pau; 🇫🇷 Pau, France