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

February 16, 2012
March 1, 2012
April 2012
April 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01542385 on ClinicalTrials.gov Archive Site
Major bleeding [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
As defined by the Bleeding Academic Research Consortium (BARC).
Same as current
Not Provided
Not Provided
 
Primary Reperfusion Secondary Stenting Trial
Immediate vs. Delayed Stenting After Primary Percutaneous Reperfusion in ST Elevation Myocardial Infarction

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
ST-elevation Myocardial Infarction
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
  • Active Comparator: Immediate stenting
    Intervention: Procedure: Percutaneous coronary intervention
  • Experimental: Delayed stenting
    Intervention: Procedure: Percutaneous coronary intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
250
October 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
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
Not Provided
 
NCT01542385
PRIMACY
Yes
Marc Jolicoeur, Montreal Heart Institute
Montreal Heart Institute
Not Provided
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
Montreal Heart Institute
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP