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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
  Purpose
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.

Condition Intervention
ST-elevation Myocardial Infarction Procedure: Stent

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Marc Jolicoeur, 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 ]
    As defined by standardized definitions


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


Enrollment: 307
Study Start Date: April 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immediate stenting
the stent selection (bare metal vs drug eluting) and implantation will be performed as recommended by current practice guidelines.
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
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.
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

Detailed Description:
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.
  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542385


Locations
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
CHUM-Hôtel-Dieu de Montréal
Montreal, Quebec, Canada, H2W 1T8
Hôpital du Sacré Cœur de Montréal
Montreal, Quebec, Canada, H4J 1C5
Centre Hospitalier Régional de Lanaudière
St-Charles-Borromée, Quebec, Canada, J6E 6J2
CHR CSSS de Trois Rivières
Trois Rivières, Quebec, Canada, G8Z 3R9
France
CH de Bastia
Bastia, France, 20200
CH de Cannes
Cannes, France, 06401
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000
Hôpital Louis-Pasteur
Le Coudray, France, 28360
HCL Hopital Croix Rousse
Lyon, France, 69317
CH Annecy Genevois
Metz-Tessy, France, 74370
Ch de Montpellier-Hôpital A. de Villneuve
Montpellier, France, 34295
CH de Nimes
Nimes, France, 30029
CH de Pau
Pau, France, 64000
CHU de Toulouse-Hôpital Rangueil
Toulouse, France, 31059
CH de Vichy
Vichy, France, 03200
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:
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
First Submitted: February 16, 2012
First Posted: March 2, 2012
Last Update Posted: August 29, 2017
Last Verified: August 2017

Keywords provided by Marc Jolicoeur, 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
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases