Primary Reperfusion Secondary Stenting Trial (PRIMACY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 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: May 26, 2016
Last verified: May 2016

February 16, 2012
May 26, 2016
April 2014
November 2017   (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.
 
Recruiting
208
November 2017
November 2017   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact: Marc E Jolicoeur, MD MSc MHS 514-376-3330 marc.jolicoeur@icm-mhi.org
Contact: Luc Harvey, RN BSc 514-376-3330 ext 2776 luc.harvey@icm-mhi.org
Canada,   France
 
NCT01542385
PRIMACY
Yes
Not Provided
Not Provided
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
May 2016

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