Primary Reperfusion Secondary Stenting Trial

NCT ID: NCT01542385

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 307 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2019-08-31

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.

Conditions

ST-elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate stenting

the stent selection (bare metal vs drug eluting) and implantation will be performed as recommended by current practice guidelines.

Group Type: ACTIVE_COMPARATOR

Stent

Intervention Type: PROCEDURE

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

Delayed stenting

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.

Group Type: EXPERIMENTAL

Stent

Intervention Type: PROCEDURE

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

Interventions

Stent

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

Intervention Type: PROCEDURE

Other Intervention Names

Thrombectomy catheter; Balloon angioplasty catheter; Coronary stent

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montreal Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Marc Jolicoeur

E. Marc Jolicoeur, MD MSc MHS FRCP-C FACC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc E Jolicoeur, MD MSc MHS

Role: STUDY_CHAIR

Montreal Heart Institute, Université de Montréal

Nandini Dendukuri, PhD

Role: STUDY_DIRECTOR

Centre for Outcomes Research, McGill University Health Centre - Research Institute

Loic Belle, MD

Role: STUDY_DIRECTOR

Hospital of Annecy, Centre Hospitalier Annecy Genevois, Annecy, France

Locations

Montreal Heart Institute

Montreal, Quebec, Canada

CHUM-Hôtel-Dieu de Montréal

Montreal, Quebec, Canada

Hôpital du Sacré Cœur de Montréal

Montreal, Quebec, Canada

Centre Hospitalier Régional de Lanaudière

Saint-Charles-Borromée, Quebec, Canada

CHR CSSS de Trois Rivières

Trois-Rivières, Quebec, Canada

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

Nîmes, , France

CH de Pau

Pau, , France

CHU de Toulouse-Hôpital Rangueil

Toulouse, , France

CH de Vichy

Vichy, , France

Countries

Canada; France

Other Identifiers

PRIMACY

Identifier Type: -

Identifier Source: org_study_id