NCT01542385

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
307

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
2 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
2.1 years until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

4.1 years

First QC Date

February 16, 2012

Last Update Submit

August 3, 2020

Conditions

ST-elevation Myocardial Infarction

Keywords

Delayed stentingDeferred stentingLate stentingpostponed stentingThrombectomyPercutaneous coronary interventionPCIAngioplastySTEMIacute myocardial infarction

Outcome Measures

Primary Outcomes (1)

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

    As defined by standardized definitions

    9 months

Secondary Outcomes (1)

  • Major bleeding

    9 months

Study Arms (2)

Immediate stenting

ACTIVE COMPARATOR

the stent selection (bare metal vs drug eluting) and implantation will be performed as recommended by current practice guidelines.

Procedure: Stent

Delayed stenting

EXPERIMENTAL

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

Interventions

StentPROCEDURE

Percutaneous coronary intervention: reperfusion with a thrombectomy catheter or a small balloon angioplasty catheter, followed by coronary stenting

Also known as: Thrombectomy catheter, Balloon angioplasty catheter, Coronary stent
Delayed stentingImmediate stenting

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

CHUM-Hôtel-Dieu de Montréal

Montreal, Quebec, H2W 1T8, Canada

Location

Hôpital du Sacré Cœur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

Centre Hospitalier Régional de Lanaudière

Saint-Charles-Borromée, Quebec, J6E 6J2, Canada

Location

CHR CSSS de Trois Rivières

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

CH de Bastia

Bastia, 20200, France

Location

CH de Cannes

Cannes, 06401, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Hôpital Louis-Pasteur

Le Coudray, 28360, France

Location

HCL Hopital Croix Rousse

Lyon, 69317, France

Location

CH Annecy Genevois

Metz-Tessy, 74370, France

Location

Ch de Montpellier-Hôpital A. de Villneuve

Montpellier, 34295, France

Location

CH de Nimes

Nîmes, 30029, France

Location

CH de Pau

Pau, 64000, France

Location

CHU de Toulouse-Hôpital Rangueil

Toulouse, 31059, France

Location

CH de Vichy

Vichy, 03200, France

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Stents

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Marc E Jolicoeur, MD MSc MHS

    Montreal Heart Institute, Université de Montréal

    STUDY CHAIR

  • Nandini Dendukuri, PhD

    Centre for Outcomes Research, McGill University Health Centre - Research Institute

    STUDY DIRECTOR

  • Loic Belle, MD

    Hospital of Annecy, Centre Hospitalier Annecy Genevois, Annecy, France

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
E. Marc Jolicoeur, MD MSc MHS FRCP-C FACC

Study Record Dates

First Submitted

February 16, 2012

First Posted

March 2, 2012

Study Start

April 1, 2014

Primary Completion

May 1, 2018

Study Completion

August 1, 2019

Last Updated

August 5, 2020

Record last verified: 2020-08

Locations

CA(5)FR(11)