Back to resultsA 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)
Primary Purpose
Myocardial Infarction, Segment Elevation Myocardial Infarction (STEMI)
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ticagrelor
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Heart attack, heart disease, cardiovascular disease, stroke, reperfusion, pre hospital settings, ticagrelor, Percutaneous Coronary Intervention
Eligibility Criteria
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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ticagrelor
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint)
(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.
ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint)
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.
Secondary Outcome Measures
1st Composite Clinical Endpoint
death/MI/stroke/urgent revascularization/stent thrombosis. Adjudicated events except death
2nd Composite Clinical Endpoint
Death/MI/urgent revascularization. Adjudicated events except death
Definite Stent Thrombosis
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. It is an adjudicated endpoint
TIMI Flow Grade 3 Post -PCI
TIMI) flow grade 3 is complete perfusion post-PCI.
ST Segment Elevation Resolution Post-PCI >= 70%
ST segment elevation resolution post PCI >=70% is defined as complete resolution
Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI
Glycoprotein (GP) IIb/IIIa inhibitors are often used as a rescue or bailout therapy to manage complications arising during percutaneous coronary intervention.
Major Bleeds Within 48 Hours
non CABG related bleeds, (PLATO definition) include Life threatening and other major bleeds
Minor and Major Bleedings Within 48 Hours
non CABG related bleeds (PLATO definition)
Major Bleeds After 48 Hours
non CABG related bleeds (PLATO definition) include life threatening and other major bleedings
Minor and Major Bleeds After 48 Hours
non CABG related bleeds (PLATO definition)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01347580
Brief Title
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)
Acronym
ATLANTIC
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Segment Elevation Myocardial Infarction (STEMI)
Keywords
Heart attack, heart disease, cardiovascular disease, stroke, reperfusion, pre hospital settings, ticagrelor, Percutaneous Coronary Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1875 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ticagrelor
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Description
Oral Ticagrelor loading dose (180 mg) followed by matching placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo followed by oral Ticagrelor loading dose (180 mg)
Primary Outcome Measure Information:
Title
Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint)
Description
(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.
Time Frame
At initial angiography, pre PCI
Title
ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint)
Description
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.
Time Frame
Between baseline and PCI
Secondary Outcome Measure Information:
Title
1st Composite Clinical Endpoint
Description
death/MI/stroke/urgent revascularization/stent thrombosis. Adjudicated events except death
Time Frame
during the 30 days of treatment
Title
2nd Composite Clinical Endpoint
Description
Death/MI/urgent revascularization. Adjudicated events except death
Time Frame
within 30 days of study
Title
Definite Stent Thrombosis
Description
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. It is an adjudicated endpoint
Time Frame
during 30 days of treatment
Title
TIMI Flow Grade 3 Post -PCI
Description
TIMI) flow grade 3 is complete perfusion post-PCI.
Time Frame
at coroangiography post-PCI
Title
ST Segment Elevation Resolution Post-PCI >= 70%
Description
ST segment elevation resolution post PCI >=70% is defined as complete resolution
Time Frame
Between baseline and ECG 60 mn post-PCI
Title
Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI
Description
Glycoprotein (GP) IIb/IIIa inhibitors are often used as a rescue or bailout therapy to manage complications arising during percutaneous coronary intervention.
Time Frame
during PCI
Title
Major Bleeds Within 48 Hours
Description
non CABG related bleeds, (PLATO definition) include Life threatening and other major bleeds
Time Frame
within 48 hours of first dose
Title
Minor and Major Bleedings Within 48 Hours
Description
non CABG related bleeds (PLATO definition)
Time Frame
within 48 hours of first dose
Title
Major Bleeds After 48 Hours
Description
non CABG related bleeds (PLATO definition) include life threatening and other major bleedings
Time Frame
after 48hours post-first dose
Title
Minor and Major Bleeds After 48 Hours
Description
non CABG related bleeds (PLATO definition)
Time Frame
after 48 hours post first dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Judith Hsia, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pr Gilles Montalescot
Organizational Affiliation
Pitie Salpetriere Hospital
Official's Role
Principal Investigator
Facility Information:
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Algiers
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Algeria
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Blida
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Algeria
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Herston
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Australia
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Southport
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Australia
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Woolloongabba
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Australia
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Graz
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Austria
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Innsbruck
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Austria
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Aalborg
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Denmark
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Odense C
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Denmark
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Århus
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Denmark
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Aubervilliers
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France
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Besançon
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France
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Boulogne Billancourt
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Bourges
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France
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Bron
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Chateauroux
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France
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Corbeil Essonnes Cedex
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France
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Creteil
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France
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Dijon
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France
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LAGNY SUR MARNE cedex
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France
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Le Chesnay
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France
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Le Coudray
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France
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Lyon Cedex 04
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France
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Lyon
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MARSEILLE cedex 15
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France
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Marseille
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Massy
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Montauban
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France
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France
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Neuilly Sur Seine
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France
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Nimes
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France
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Paris Cedex 13
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France
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PARIS Cedex 15
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France
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Paris
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PESSAC Cedex
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Quincy sous Sénart
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France
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Rouen Cedex
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France
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Strasbourg
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France
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TOURS Cedex 9
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France
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TOURS cedex
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France
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VANNES cedex
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France
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Bad Friedrichshall
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Germany
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Germany
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Germany
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Germany
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Germany
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Mainz
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Wuppertal
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Budapest
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Szeged
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Hungary
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Arezzo
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Italy
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Ascoli Piceno
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Italy
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Cona
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Italy
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Forlì
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Italy
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Genova
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Italy
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Grosseto
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Italy
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Massa
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Italy
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Seriate
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Italy
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Siena
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Italy
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Alkmaar
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Netherlands
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Arnhem
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Netherlands
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Den Bosch
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Netherlands
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Terneuzen
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Netherlands
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A Coruña
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Spain
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Alicante
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Hospitalet de Llobregat(Barcel
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Santiago(A Coruña)
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Spain
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Sevilla
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Spain
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Vigo(Pontevedra)
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Spain
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Gävle
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Sweden
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Linköping
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Sweden
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Uppsala
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Sweden
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Örebro
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Sweden
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Ashford
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Belfast
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Cambridge
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Coventry
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Eastbourne
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Hastings
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Middlesborough
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United Kingdom
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Newcastle-Upon-Tyne
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United Kingdom
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Norwich
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United Kingdom
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Sheffield
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United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
25175921
Citation
Montalescot G, van 't Hof AW, Lapostolle F, Silvain J, Lassen JF, Bolognese L, Cantor WJ, Cequier A, Chettibi M, Goodman SG, Hammett CJ, Huber K, Janzon M, Merkely B, Storey RF, Zeymer U, Stibbe O, Ecollan P, Heutz WM, Swahn E, Collet JP, Willems FF, Baradat C, Licour M, Tsatsaris A, Vicaut E, Hamm CW; ATLANTIC Investigators. Prehospital ticagrelor in ST-segment elevation myocardial infarction. N Engl J Med. 2014 Sep 11;371(11):1016-27. doi: 10.1056/NEJMoa1407024. Epub 2014 Sep 1.
Results Reference
result
PubMed Identifier
30353444
Citation
Lapostolle F, Van't Hof AW, Hamm CW, Stibbe O, Ecollan P, Collet JP, Silvain J, Lassen JF, Heutz WMJM, Bolognese L, Cantor WJ, Cequier A, Chettibi M, Goodman SG, Hammett CJ, Huber K, Janzon M, Merkely B, Storey RF, Ten Berg J, Zeymer U, Licour M, Tsatsaris A, Montalescot G; ATLANTIC Investigators. Morphine and Ticagrelor Interaction in Primary Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction: ATLANTIC-Morphine. Am J Cardiovasc Drugs. 2019 Apr;19(2):173-183. doi: 10.1007/s40256-018-0305-0.
Results Reference
derived
PubMed Identifier
30302940
Citation
Fabris E, Van't Hof A, Hamm CW, Lapostolle F, Lassen JF, Goodman SG, Ten Berg JM, Bolognese L, Cequier A, Chettibi M, Hammett CJ, Huber K, Janzon M, Merkely B, Storey RF, Zeymer U, Cantor WJ, Kerneis M, Diallo A, Vicaut E, Montalescot G; ATLANTIC investigators. Pre-hospital administration of ticagrelor in diabetic patients with ST-elevation myocardial infarction undergoing primary angioplasty: A sub-analysis of the ATLANTIC trial. Catheter Cardiovasc Interv. 2019 Jun 1;93(7):E369-E377. doi: 10.1002/ccd.27921. Epub 2018 Oct 9.
Results Reference
derived
PubMed Identifier
29421015
Citation
Bagai A, Goodman SG, Cantor WJ, Vicaut E, Bolognese L, Cequier A, Chettibi M, Hammett CJ, Huber K, Janzon M, Lapostolle F, Lassen JF, Merkely B, Storey RF, Ten Berg JM, Zeymer U, Diallo A, Hamm CW, Tsatsaris A, El Khoury J, Van't Hof AW, Montalescot G. Duration of ischemia and treatment effects of pre- versus in-hospital ticagrelor in patients with ST-segment elevation myocardial infarction: Insights from the ATLANTIC study. Am Heart J. 2018 Feb;196:56-64. doi: 10.1016/j.ahj.2017.10.021. Epub 2017 Nov 4.
Results Reference
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PubMed Identifier
29421001
Citation
Kilic S, Fabris E, Van't Hof AWJ, Hamm CW, Lapostolle F, Lassen JF, Tsatsaris A, Diallo A, Vicaut E, Montalescot G; ATLANTIC Investigators. Thrombus aspiration and prehospital ticagrelor administration in ST-elevation myocardial infarction: Findings from the ATLANTIC trial. Am Heart J. 2018 Feb;196:1-8. doi: 10.1016/j.ahj.2017.09.018. Epub 2017 Oct 3.
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Venetsanos D, Sederholm Lawesson S, Alfredsson J, Janzon M, Cequier A, Chettibi M, Goodman SG, Van't Hof AW, Montalescot G, Swahn E. Association between gender and short-term outcome in patients with ST elevation myocardial infraction participating in the international, prospective, randomised Administration of Ticagrelor in the catheterisation Laboratory or in the Ambulance for New ST elevation myocardial Infarction to open the Coronary artery (ATLANTIC) trial: a prespecified analysis. BMJ Open. 2017 Sep 21;7(9):e015241. doi: 10.1136/bmjopen-2016-015241.
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PubMed Identifier
28622941
Citation
Cayla G, Lapostolle F, Ecollan P, Stibbe O, Benezet JF, Henry P, Hammett CJ, Lassen JF, Storey RF, Ten Berg JM, Hamm CW, Van't Hof AW, Montalescot G; ACTION study group. Pre-hospital ticagrelor in ST-segment elevation myocardial infarction in the French ATLANTIC population. Int J Cardiol. 2017 Oct 1;244:49-53. doi: 10.1016/j.ijcard.2017.06.009. Epub 2017 Jun 9.
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Lupi A, Schaffer A, Lazzero M, Tessitori M, De Martino L, Rognoni A, Bongo AS, Porto I. Pre-hospital ticagrelor in patients with ST-segment elevation myocardial infarction with long transport time to primary PCI facility. Cardiovasc Revasc Med. 2016 Dec;17(8):528-534. doi: 10.1016/j.carrev.2016.08.005. Epub 2016 Aug 20.
Results Reference
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PubMed Identifier
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Citation
Silvain J, Storey RF, Cayla G, Esteve JB, Dillinger JG, Rousseau H, Tsatsaris A, Baradat C, Salhi N, Hamm CW, Lapostolle F, Lassen JF, Collet JP, Ten Berg JM, Van't Hof AW, Montalescot G. P2Y12 receptor inhibition and effect of morphine in patients undergoing primary PCI for ST-segment elevation myocardial infarction. The PRIVATE-ATLANTIC study. Thromb Haemost. 2016 Aug 1;116(2):369-78. doi: 10.1160/TH15-12-0944. Epub 2015 May 19.
Results Reference
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PubMed Identifier
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Citation
Montalescot G, van 't Hof AW, Bolognese L, Cantor WJ, Cequier A, Chettibi M, Collet JP, Goodman SG, Hammett CJ, Huber K, Janzon M, Lapostolle F, Lassen JF, Licour M, Merkely B, Salhi N, Silvain J, Storey RF, Ten Berg JM, Tsatsaris A, Zeymer U, Vicaut E, Hamm CW; ATLANTIC Investigators. Effect of Pre-Hospital Ticagrelor During the First 24 h After Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction: The ATLANTIC-H(2)(4) Analysis. JACC Cardiovasc Interv. 2016 Apr 11;9(7):646-56. doi: 10.1016/j.jcin.2015.12.024. Epub 2016 Mar 5.
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Results Reference
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Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=482&filename=D5130L00006_Protocol_Redacted.pdf
Description
D5130L00006_Protocol
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=482&filename=D5130L00006_CSR_Synopsis.pdf
Description
D5130L00006_CSR_Synopsis
Learn more about this trial
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)
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