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Primary Reperfusion Secondary Stenting Trial (PRIMACY)

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Marc Jolicoeur, 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: July 12, 2017
Last verified: July 2017
  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).


Estimated Enrollment: 304
Study Start Date: April 2014
Estimated Study Completion Date: August 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Luc Harvey, RN BSc 514-376-3330 ext 2776 luc.harvey@icm-mhi.org

Locations
Canada, Ontario
Thunder Bay Regional Health Sciences Center Withdrawn
Thunder Bay, Ontario, Canada, P7B 6V4
Canada, Quebec
CSSS de Chicoutimi Withdrawn
Chicoutimi, Quebec, Canada, G7H 5H6
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada, H1T 1C8
Contact: Luc Harvey    5143763330 ext 2776    luc.harvey@icm-mhi.org   
Contact: Marie-Gabrielle Lessard    5143763330 ext 2094    marie-gabrielle.lessard@icm-mhi.org   
Principal Investigator: Marc Jolicoeur         
CHUM-Hôtel-Dieu de Montréal Recruiting
Montreal, Quebec, Canada, H2W 1T8
Contact: Renée Duclos    514-890-8000 ext 14803    renee.duclos.chum@ssss.gouv.qc.ca   
Principal Investigator: Samer Mansour         
Hôpital du Sacré Cœur de Montréal Recruiting
Montreal, Quebec, Canada, H4J 1C5
Contact: Chantale Mercure    514-338-2222 ext 3721    c-mercure@crhsc.rtss.qc.ca   
Principal Investigator: Erick Schampaert         
Centre Hospitalier Régional de Lanaudière Active, not recruiting
St-Charles-Borromée, Quebec, Canada, J6E 6J2
CHR CSSS de Trois Rivières Active, not recruiting
Trois Rivières, Quebec, Canada, G8Z 3R9
France
CH de Bastia Recruiting
Bastia, France, 20200
Principal Investigator: Boueri         
CH de Cannes Recruiting
Cannes, France, 06401
Contact: Gilles Zemour         
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63000
Contact: géraud Souteyrand         
Hôpital Louis-Pasteur Recruiting
Le Coudray, France, 28360
Contact: Gérgoire Range         
HCL Hopital Croix Rousse Recruiting
Lyon, France, 69317
Principal Investigator: Bharbaoui         
CH Annecy Genevois Recruiting
Metz-Tessy, France, 74370
Contact: Loic Belle         
Ch de Montpellier-Hôpital A. de Villneuve Recruiting
Montpellier, France, 34295
Contact: Francois Roubille         
CH de Nimes Recruiting
Nimes, France, 30029
Principal Investigator: Cayla         
CH de Pau Recruiting
Pau, France, 64000
Contact: Nicolas Delarche         
CHU de Toulouse-Hôpital Rangueil Recruiting
Toulouse, France, 31059
Contact: Bouisset Fréderic         
CH de Vichy Recruiting
Vichy, France, 03200
Contact: Xavier Marcaggi         
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
Study First Received: February 16, 2012
Last Updated: July 12, 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
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 17, 2017