Primary Reperfusion Secondary Stenting Trial (PRIMACY)

This study is not yet open for participant recruitment.
Verified March 2012 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: March 1, 2012
Last verified: March 2012
  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: 250
Study Start Date: April 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (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. ST-segment elevation myocardial infarction, presenting within 6 hours of symptoms onset, and persisting for more than 20 minutes;
  3. High-risk STEMI as indicated by an ECG that fulfills any of the following three criteria:

    • ≥ 2 mm ST elevation in two anterior or lateral leads; or
    • ≥ 2 mm ST elevation in two inferior leads coupled with ST depression in two contiguous anterior leads for a total ST deviation of ≥ 8 mm; or
    • New left bundle branch block (LBBB) with at least 1 mm concordant ST elevation
  4. Successful reperfusion (TIMI 3 flow) with a minimally invasive mechanical device (wire, thrombectomy, small size angioplasty catheter) persisting for more than 10 minutes
  5. Infarct-related artery with a diameter above 2.5 mm.

Exclusion Criteria:

  1. Prior STEMI in the qualifying 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. High risk of bleeding (need for systemic anticoagulation with vitamin K antagonist or other agents, severe thrombocytopenia, diathesis);
  7. Contraindication to either ticagrelor, prasugrel or GpIIbIIIa inhibitors; including if prasugrel is selected age ≥ 75 years if , body weight < 60 kg and prior transient ischemic attacks, stroke, or intracranial hemorrhage;
  8. STEMI with Killip III-IV or cardiogenic shock;
  9. STEMI presenting with sudden death, ventricular fibrillation, or sustained ventricular tachycardia;
  10. Pregnant or breastfeeding;
  11. Chronic renal insufficiency (creatinine clearance < 50ml/min);
  12. Contra-indication to percutaneous coronary intervention (severe uncontrolled iodine allergy, no vascular access available, intolerance to P2Y12 inhibitors);
  13. Previous heart transplantation;
  14. Any other conditions which in the opinion of the investigator, may either put the subject at risk or influence the result of the study (active cancer, risk for non-compliance, and risk for being lost to follow up);
  15. Participation in another investigational drug or device study in the last 30 days.
  Contacts and Locations
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

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: March 1, 2012
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
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014