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Primary Reperfusion Secondary Stenting Trial (PRIMACY)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01542385
First Posted: March 2, 2012
Last Update Posted: August 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marc Jolicoeur, Montreal Heart Institute
February 16, 2012
March 2, 2012
August 29, 2017
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 ]
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 ]
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 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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
ST-elevation Myocardial Infarction
Procedure: Stent
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
    the stent selection (bare metal vs drug eluting) and implantation will be performed as recommended by current practice guidelines.
    Intervention: Procedure: Stent
  • Experimental: Delayed stenting
    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: Procedure: Stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
307
April 2018
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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
August 2017

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