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Completed

NCT Number: NCT01542385

Primary Reperfusion Secondary Stenting Trial

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHUM-Hôtel-Dieu de Montréal, Montreal, Quebec, Canada

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About this study

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, or unplanned target vessel revascularization over a 9-month period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 80 years;
  • STEMI, presenting within 12 hours of symptoms onset, and persisting for more than 20 minutes;
  • 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;
  • Infarct-related artery with TIMI flow 0 or 1 at baseline angiogram;
  • 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;
  • Infarct related artery with a diameter above 2.5 mm.

Exclusion criteria

  • Prior STEMI in the qualifying coronary artery;
  • Coronary dissection following reperfusion;
  • STEMI caused by acute stent thrombosis or a venous or arterial bypass graft occlusion;
  • Significant left main disease, as determined by angiography (≥ 50%) or other imaging technologies;
  • Cardiac condition requiring emergent or urgent surgical repair;
  • Failed thrombolysis and rescue PCI;
  • High risk of bleeding;
  • Contraindication to either ticagrelor or GpIIb/IIIa inhibitors;
  • STEMI with Killip III-IV or cardiogenic shock or presenting as sudden death, ventricular fibrillation, or sustained ventricular tachycardia;
  • Women who are pregnant or breastfeeding;
  • Creatinine clearance < 20 ml/min;
  • Other contraindication to PCI;
  • Participation with another investigational drug or investigational device study within 30 days prior to randomization (participation to registries is allowed);
  • Any condition that in the opinion of the investigator would preclude compliance with the study protocol.

Treatment and study plan

stent

Procedure

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

Primary outcomes

  1. The combined occurence of cardiac death, non-fatal myocardial infarction, congestive heart failure, and urgent target vessel revascularization

    Time frame: 9 months

    As defined by standardized definitions

Secondary outcomes

  1. Major bleeding

    Time frame: 9 months

    As defined by the Bleeding Academic Research Consortium (BARC).

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Registry information

Official study title

Immediate vs. Delayed Stenting After Primary Percutaneous Reperfusion in ST Elevation Myocardial Infarction

Acronym: PRIMACY

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Mar 2, 2012
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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