Primary Reperfusion Secondary Stenting Trial

ST-elevation Myocardial Infarction Clinical Trial

— PRIMACY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01542385
• Other study ID #: PRIMACY
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: August 2019

Study information

• Verified date: August 2020
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: August 2019
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-elevation Myocardial Infarction

Intervention

Procedure:
• Stent
Percutaneous coronary intervention: reperfusion with a thrombectomy catheter or a small balloon angioplasty catheter, followed by coronary stenting

Locations

Country	Name	City	State
Canada	CHUM-Hôtel-Dieu de Montréal	Montreal	Quebec
Canada	Hôpital du Sacré Cœur de Montréal	Montreal	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Centre Hospitalier Régional de Lanaudière	St-Charles-Borromée	Quebec
Canada	CHR CSSS de Trois Rivières	Trois Rivières	Quebec
France	CH de Bastia	Bastia
France	CH de Cannes	Cannes
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	Hôpital Louis-Pasteur	Le Coudray
France	HCL Hopital Croix Rousse	Lyon
France	CH Annecy Genevois	Metz-Tessy
France	Ch de Montpellier-Hôpital A. de Villneuve	Montpellier
France	CH de Nimes	Nimes
France	CH de Pau	Pau
France	CHU de Toulouse-Hôpital Rangueil	Toulouse
France	CH de Vichy	Vichy

Sponsors (1)

Lead Sponsor	Collaborator
Montreal Heart Institute

Countries where clinical trial is conducted

Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Major bleeding	As defined by the Bleeding Academic Research Consortium (BARC).	9 months

External Links

•   Canadian Journal of Cardiology Editorial
•   Methods paper