search
Back to results

Primary Reperfusion Secondary Stenting Trial (PRIMACY)

Primary Purpose

ST-elevation Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Stent
Sponsored by
Montreal Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-elevation Myocardial Infarction focused on measuring Delayed stenting, Deferred stenting, Late stenting, postponed stenting, Thrombectomy, Percutaneous coronary intervention, PCI, Angioplasty, STEMI, acute myocardial infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Montreal Heart Institute
  • CHUM-Hôtel-Dieu de Montréal
  • Hôpital du Sacré Cœur de Montréal
  • Centre Hospitalier Régional de Lanaudière
  • CHR CSSS de Trois Rivières
  • CH de Bastia
  • CH de Cannes
  • CHU de Clermont-Ferrand
  • Hôpital Louis-Pasteur
  • HCL Hopital Croix Rousse
  • CH Annecy Genevois
  • Ch de Montpellier-Hôpital A. de Villneuve
  • CH de Nimes
  • CH de Pau
  • CHU de Toulouse-Hôpital Rangueil
  • CH de Vichy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Immediate stenting

Delayed stenting

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Major bleeding
As defined by the Bleeding Academic Research Consortium (BARC).

Full Information

First Posted
February 16, 2012
Last Updated
August 3, 2020
Sponsor
Montreal Heart Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT01542385
Brief Title
Primary Reperfusion Secondary Stenting Trial
Acronym
PRIMACY
Official Title
Immediate vs. Delayed Stenting After Primary Percutaneous Reperfusion in ST Elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montreal Heart Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-elevation Myocardial Infarction
Keywords
Delayed stenting, Deferred stenting, Late stenting, postponed stenting, Thrombectomy, Percutaneous coronary intervention, PCI, Angioplasty, STEMI, acute myocardial infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
307 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate stenting
Arm Type
Active Comparator
Arm Description
the stent selection (bare metal vs drug eluting) and implantation will be performed as recommended by current practice guidelines.
Arm Title
Delayed stenting
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Stent
Other Intervention Name(s)
Thrombectomy catheter, Balloon angioplasty catheter, Coronary stent
Intervention Description
Percutaneous coronary intervention: reperfusion with a thrombectomy catheter or a small balloon angioplasty catheter, followed by coronary stenting
Primary Outcome Measure Information:
Title
The combined occurence of cardiac death, non-fatal myocardial infarction, congestive heart failure, and urgent target vessel revascularization
Description
As defined by standardized definitions
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Major bleeding
Description
As defined by the Bleeding Academic Research Consortium (BARC).
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc E Jolicoeur, MD MSc MHS
Organizational Affiliation
Montreal Heart Institute, Université de Montréal
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nandini Dendukuri, PhD
Organizational Affiliation
Centre for Outcomes Research, McGill University Health Centre - Research Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Loic Belle, MD
Organizational Affiliation
Hospital of Annecy, Centre Hospitalier Annecy Genevois, Annecy, France
Official's Role
Study Director
Facility Information:
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
CHUM-Hôtel-Dieu de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Hôpital du Sacré Cœur de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Centre Hospitalier Régional de Lanaudière
City
St-Charles-Borromée
State/Province
Quebec
ZIP/Postal Code
J6E 6J2
Country
Canada
Facility Name
CHR CSSS de Trois Rivières
City
Trois Rivières
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Facility Name
CH de Bastia
City
Bastia
ZIP/Postal Code
20200
Country
France
Facility Name
CH de Cannes
City
Cannes
ZIP/Postal Code
06401
Country
France
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Hôpital Louis-Pasteur
City
Le Coudray
ZIP/Postal Code
28360
Country
France
Facility Name
HCL Hopital Croix Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
CH Annecy Genevois
City
Metz-Tessy
ZIP/Postal Code
74370
Country
France
Facility Name
Ch de Montpellier-Hôpital A. de Villneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CH de Nimes
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
CH de Pau
City
Pau
ZIP/Postal Code
64000
Country
France
Facility Name
CHU de Toulouse-Hôpital Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CH de Vichy
City
Vichy
ZIP/Postal Code
03200
Country
France

12. IPD Sharing Statement

Learn more about this trial

Primary Reperfusion Secondary Stenting Trial

We'll reach out to this number within 24 hrs