A 30 Day Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for Percutaneous Coronary Intervention (PCI) (ATLANTIC)

July 20, 2015 updated by: AstraZeneca

A 30 Day International, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase IV Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for PCI.

The aim of this study is to determine whether initiation of ticagrelor as early as in the ambulance setting leads to a rapid reperfusion of the infarct-related artery therefore facilitating the Percutaneous Coronary Intervention (PCI) and optimizing the outcome for the patient.

The study will assess the efficacy and safety of pre-hospital compared to in-hospital administration of ticagrelor in co-administration with aspirin, on restoring the blood flow in the occluded heart artery and improving the myocardial perfusion in patients suffering from myocardial infarction and planned to have a PCI. Patients can be randomised in either one of the 2 arms:

re-hospital ticagrelor arm: Patients will receive a loading dose of 180 mg ticagrelor for the pre-hospital administration and placebo for in-hospital administration.

or In-hospital ticagrelor arm: Patients will receive a placebo for pre-hospital administration and 180 mg ticagrelor loading dose for in-hospital administration.

Patients are initially managed by ambulance physician/personnel in pre hospital settings. They are then transferred into a Catheterization room to undergo a PCI.

After the administration of the loading dose of ticagrelor (double blind), patients will continue on ticagrelor 90 mg bid and be followed in study for 30 days post randomisation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1875

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Algiers, Algeria
        • Research Site
      • Blida, Algeria
        • Research Site
  • Australia
      • Herston, Australia
        • Research Site
      • Southport, Australia
        • Research Site
      • Woolloongabba, Australia
        • Research Site
  • Austria
      • Graz, Austria
        • Research Site
      • Innsbruck, Austria
        • Research Site
      • Wien, Austria
        • Research Site
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Research Site
    • Ontario
      • Newmarket, Ontario, Canada
        • Research Site
      • Scarborough, Ontario, Canada
        • Research Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada
        • Research Site
  • Denmark
      • Aalborg, Denmark
        • Research Site
      • Odense C, Denmark
        • Research Site
      • Århus, Denmark
        • Research Site
  • France
      • Aubervilliers, France
        • Research Site
      • Besançon, France
        • Research Site
      • Boulogne Billancourt, France
        • Research Site
      • Bourges, France
        • Research Site
      • Bron, France
        • Research Site
      • Chateauroux, France
        • Research Site
      • Corbeil Essonnes Cedex, France
        • Research Site
      • Creteil, France
        • Research Site
      • Dijon, France
        • Research Site
      • LAGNY SUR MARNE cedex, France
        • Research Site
      • Le Chesnay, France
        • Research Site
      • Le Coudray, France
        • Research Site
      • Lyon, France
        • Research Site
      • Lyon Cedex 04, France
        • Research Site
      • MARSEILLE cedex 15, France
        • Research Site
      • MONTREUIL Cedex, France
        • Research Site
      • Marseille, France
        • Research Site
      • Massy, France
        • Research Site
      • Melun, France
        • Research Site
      • Montauban, France
        • Research Site
      • Montfermeil, France
        • Research Site
      • Neuilly Sur Seine, France
        • Research Site
      • Nimes, France
        • Research Site
      • PARIS Cedex 15, France
        • Research Site
      • PESSAC Cedex, France
        • Research Site
      • Paris, France
        • Research Site
      • Paris Cedex 13, France
        • Research Site
      • Quincy sous Sénart, France
        • Research Site
      • Rouen Cedex, France
        • Research Site
      • Strasbourg, France
        • Research Site
      • TOURS Cedex 9, France
        • Research Site
      • TOURS cedex, France
        • Research Site
      • VANNES cedex, France
        • Research Site
  • Germany
      • Bad Friedrichshall, Germany
        • Research Site
      • Bad Nauheim, Germany
        • Research Site
      • Darmstadt, Germany
        • Research Site
      • Esslingen, Germany
        • Research Site
      • Freiburg, Germany
        • Research Site
      • Gießen, Germany
        • Research Site
      • Hannover, Germany
        • Research Site
      • Ludwigshafen, Germany
        • Research Site
      • Lüdenscheid, Germany
        • Research Site
      • Mainz, Germany
        • Research Site
      • Merseburg, Germany
        • Research Site
      • Wuppertal, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Pécs, Hungary
        • Research Site
      • Szeged, Hungary
        • Research Site
  • Italy
      • Arezzo, Italy
        • Research Site
      • Ascoli Piceno, Italy
        • Research Site
      • Cona, Italy
        • Research Site
      • Forlì, Italy
        • Research Site
      • Genova, Italy
        • Research Site
      • Grosseto, Italy
        • Research Site
      • Massa, Italy
        • Research Site
      • Seriate, Italy
        • Research Site
      • Siena, Italy
        • Research Site
  • Netherlands
      • Alkmaar, Netherlands
        • Research Site
      • Arnhem, Netherlands
        • Research Site
      • Den Bosch, Netherlands
        • Research Site
      • Terneuzen, Netherlands
        • Research Site
  • Spain
      • A Coruña, Spain
        • Research Site
      • Alicante, Spain
        • Research Site
      • Badalona, Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Hospitalet de Llobregat(Barcel, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Málaga, Spain
        • Research Site
      • Santiago(A Coruña), Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Vigo(Pontevedra), Spain
        • Research Site
  • Sweden
      • Gävle, Sweden
        • Research Site
      • Linköping, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site
      • Örebro, Sweden
        • Research Site
  • United Kingdom
      • Ashford, United Kingdom
        • Research Site
      • Belfast, United Kingdom
        • Research Site
      • Cambridge, United Kingdom
        • Research Site
      • Coventry, United Kingdom
        • Research Site
      • Eastbourne, United Kingdom
        • Research Site
      • Hastings, United Kingdom
        • Research Site
      • Middlesborough, United Kingdom
        • Research Site
      • Newcastle-Upon-Tyne, United Kingdom
        • Research Site
      • Norwich, United Kingdom
        • Research Site
      • Sheffield, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Women must not be of child-bearing potential (1 year post-menopausal or surgically sterile).
  • Symptoms of acute MI of more than 30 min but less than 6 hours
  • New persistent ST-segment elevation ≥ 1 mm in two or more contiguous electrocardiogram (ECG) leads.

Exclusion Criteria:

  • Expected time to 1st PCI balloon inflation in the hospital, from the qualifying ECG is more than 120 minutes
  • Contraindication to ticagrelor (refer to SmPC)
  • Concomitant medication that may increase the risk of bleeding [e.g non steroidal anti-inflammatory drugs (NSAIDs), oral anticoagulant and / or fibrinolytics, planned or administered 24 hours before randomization]
  • Any of the following conditions in the absence of a functioning implanted pacemaker: known SSS, second or third degree AVB, or documented syncope of suspected bradycardic origin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ticagrelor
Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
Drug: Ticagrelor
Oral Ticagrelor loading dose (180 mg) followed by matching placebo
Experimental: Placebo
Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
Drug: Placebo
Placebo followed by oral Ticagrelor loading dose (180 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint)
Time Frame: At initial angiography, pre PCI
(TIMI) flow grade classification is used to assess coronary blood flow in acute coronary syndromes. grade 0:no reperfusion, grade 1: penetration without perfusion, grade 2: Partial reperfusion, grade 3: complete perfusion.
At initial angiography, pre PCI
ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint)
Time Frame: Between baseline and PCI
ST segment elevation resolution is the mean ST elevation pre-hospital minus the mean STelevation pre-PCI divided by the mean ST elevation pre-hospital. It is expressed as a percentage and split in 2 categories , complete (≥70%) versus incomplete (<70%) resolution.
Between baseline and PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1st Composite Clinical Endpoint
Time Frame: during the 30 days of treatment
death/MI/stroke/urgent revascularization/stent thrombosis. Adjudicated events except death
during the 30 days of treatment
2nd Composite Clinical Endpoint
Time Frame: within 30 days of study
Death/MI/urgent revascularization. Adjudicated events except death
within 30 days of study
Definite Stent Thrombosis
Time Frame: during 30 days of treatment
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. It is an adjudicated endpoint
during 30 days of treatment
TIMI Flow Grade 3 Post -PCI
Time Frame: at coroangiography post-PCI
TIMI) flow grade 3 is complete perfusion post-PCI.
at coroangiography post-PCI
ST Segment Elevation Resolution Post-PCI >= 70%
Time Frame: Between baseline and ECG 60 mn post-PCI
ST segment elevation resolution post PCI >=70% is defined as complete resolution
Between baseline and ECG 60 mn post-PCI
Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI
Time Frame: during PCI
Glycoprotein (GP) IIb/IIIa inhibitors are often used as a rescue or bailout therapy to manage complications arising during percutaneous coronary intervention.
during PCI
Major Bleeds Within 48 Hours
Time Frame: within 48 hours of first dose
non CABG related bleeds, (PLATO definition) include Life threatening and other major bleeds
within 48 hours of first dose
Minor and Major Bleedings Within 48 Hours
Time Frame: within 48 hours of first dose
non CABG related bleeds (PLATO definition)
within 48 hours of first dose
Major Bleeds After 48 Hours
Time Frame: after 48hours post-first dose
non CABG related bleeds (PLATO definition) include life threatening and other major bleedings
after 48hours post-first dose
Minor and Major Bleeds After 48 Hours
Time Frame: after 48 hours post first dose
non CABG related bleeds (PLATO definition)
after 48 hours post first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Dr Judith Hsia, MD, AstraZeneca
  • Principal Investigator: Pr Gilles Montalescot, Pitié Salpêtrière hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

April 19, 2011

First Submitted That Met QC Criteria

May 3, 2011

First Posted (Estimate)

May 4, 2011

Study Record Updates

Last Update Posted (Estimate)

July 22, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5130L00006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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