Primary Reperfusion Secondary Stenting Trial (PRIMACY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Montreal Heart Institute
Sponsor:
Information provided by (Responsible Party):
Marc Jolicoeur, Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT01542385
First received: February 16, 2012
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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, and target vessel revascularization at 90 days.


Condition Intervention Phase
ST-elevation Myocardial Infarction
Procedure: Percutaneous coronary intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immediate vs. Delayed Stenting After Primary Percutaneous Reperfusion in ST Elevation Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Montreal Heart Institute:

Primary Outcome Measures:
  • The combined occurence of cardiac death, non-fatal myocardial infarction, congestive heart failure, and urgent target vessel revascularization [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    As defined by standardized definitions


Secondary Outcome Measures:
  • Major bleeding [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    As defined by the Bleeding Academic Research Consortium (BARC).


Estimated Enrollment: 304
Study Start Date: April 2014
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immediate stenting Procedure: Percutaneous coronary intervention
Percutaneous coronary intervention: reperfusion with a thrombectomy catheter or a small balloon angioplasty catheter, followed by coronary stenting
Other Names:
  • Thrombectomy catheter
  • Balloon angioplasty catheter
  • Coronary stent
Experimental: Delayed stenting Procedure: Percutaneous coronary intervention
Percutaneous coronary intervention: reperfusion with a thrombectomy catheter or a small balloon angioplasty catheter, followed by coronary stenting
Other Names:
  • Thrombectomy catheter
  • Balloon angioplasty catheter
  • Coronary stent

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 3 flow), either spontaneously or after wire passage, thrombectomy, small size (≤ 1.5mm) 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 contra-indication to PCI;
  13. Participation to 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542385

Contacts
Contact: Marc E Jolicoeur, MD MSc MHS 514-376-3330 marc.jolicoeur@icm-mhi.org
Contact: Nathalie St-Jean 514-376-3330 ext 3621 nathalie.st-jean@icm-mhi.org

Locations
Canada, Quebec
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada, H1T 1C8
Contact: Luc Harvey    5143763330 ext 2776    luc.harvey@icm-mhi.org   
Contact: Marie-Gabrielle Lessard    5143763330 ext 2094    marie-gabrielle.lessard@icm-mhi.org   
Principal Investigator: Marc Jolicoeur         
Sponsors and Collaborators
Montreal Heart Institute
Investigators
Study Chair: Marc E Jolicoeur, MD MSc MHS Montreal Heart Institute, Université de Montréal
Study Director: Lawrence Joseph, PhD McGill University Health Center
Study Director: Jean-Caude Tardif, MD Montreal Heart Institute, Université de Montréal
  More Information

Additional Information:
No publications provided

Responsible Party: Marc Jolicoeur, E. Marc Jolicoeur, MD MSc MHS FRCP-C FACC, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT01542385     History of Changes
Other Study ID Numbers: PRIMACY
Study First Received: February 16, 2012
Last Updated: April 23, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Montreal Heart Institute:
Delayed stenting
Deferred stenting
Late stenting
postponed stenting
Thrombectomy
Percutaneous coronary intervention
PCI
Angioplasty
STEMI
acute myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014