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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01347580




Registration number
NCT01347580
Ethics application status
Date submitted
19/04/2011
Date registered
4/05/2011
Date last updated
22/07/2015

Titles & IDs
Public 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)
Scientific 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.
Secondary ID [1] 0 0
D5130L00006
Universal Trial Number (UTN)
Trial acronym
ATLANTIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 0 0
Segment Elevation Myocardial Infarction (STEMI) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ticagrelor
Treatment: Drugs - Placebo

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.

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.


Treatment: Drugs: Ticagrelor
Oral Ticagrelor loading dose (180 mg) followed by matching placebo

Treatment: Drugs: Placebo
Placebo followed by oral Ticagrelor loading dose (180 mg)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
At initial angiography, pre PCI
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Between baseline and PCI
Secondary outcome [1] 0 0
1st Composite Clinical Endpoint - death/MI/stroke/urgent revascularization/stent thrombosis. Adjudicated events except death
Timepoint [1] 0 0
during the 30 days of treatment
Secondary outcome [2] 0 0
2nd Composite Clinical Endpoint - Death/MI/urgent revascularization. Adjudicated events except death
Timepoint [2] 0 0
within 30 days of study
Secondary outcome [3] 0 0
Definite Stent Thrombosis - Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. It is an adjudicated endpoint
Timepoint [3] 0 0
during 30 days of treatment
Secondary outcome [4] 0 0
TIMI Flow Grade 3 Post -PCI - TIMI) flow grade 3 is complete perfusion post-PCI.
Timepoint [4] 0 0
at coroangiography post-PCI
Secondary outcome [5] 0 0
ST Segment Elevation Resolution Post-PCI >= 70% - ST segment elevation resolution post PCI >=70% is defined as complete resolution
Timepoint [5] 0 0
Between baseline and ECG 60 mn post-PCI
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
during PCI
Secondary outcome [7] 0 0
Major Bleeds Within 48 Hours - non CABG related bleeds, (PLATO definition) include Life threatening and other major bleeds
Timepoint [7] 0 0
within 48 hours of first dose
Secondary outcome [8] 0 0
Minor and Major Bleedings Within 48 Hours - non CABG related bleeds (PLATO definition)
Timepoint [8] 0 0
within 48 hours of first dose
Secondary outcome [9] 0 0
Major Bleeds After 48 Hours - non CABG related bleeds (PLATO definition) include life threatening and other major bleedings
Timepoint [9] 0 0
after 48hours post-first dose
Secondary outcome [10] 0 0
Minor and Major Bleeds After 48 Hours - non CABG related bleeds (PLATO definition)
Timepoint [10] 0 0
after 48 hours post first dose

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Herston
Recruitment hospital [2] 0 0
Research Site - Southport
Recruitment hospital [3] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Herston
Recruitment postcode(s) [2] 0 0
- Southport
Recruitment postcode(s) [3] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Algeria
State/province [1] 0 0
Algiers
Country [2] 0 0
Algeria
State/province [2] 0 0
Blida
Country [3] 0 0
Austria
State/province [3] 0 0
Graz
Country [4] 0 0
Austria
State/province [4] 0 0
Innsbruck
Country [5] 0 0
Austria
State/province [5] 0 0
Wien
Country [6] 0 0
Canada
State/province [6] 0 0
Nova Scotia
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Saskatchewan
Country [9] 0 0
Denmark
State/province [9] 0 0
Aalborg
Country [10] 0 0
Denmark
State/province [10] 0 0
Odense C
Country [11] 0 0
Denmark
State/province [11] 0 0
Århus
Country [12] 0 0
France
State/province [12] 0 0
Aubervilliers
Country [13] 0 0
France
State/province [13] 0 0
Besançon
Country [14] 0 0
France
State/province [14] 0 0
Boulogne Billancourt
Country [15] 0 0
France
State/province [15] 0 0
Bourges
Country [16] 0 0
France
State/province [16] 0 0
Bron
Country [17] 0 0
France
State/province [17] 0 0
Chateauroux
Country [18] 0 0
France
State/province [18] 0 0
Corbeil Essonnes Cedex
Country [19] 0 0
France
State/province [19] 0 0
Creteil
Country [20] 0 0
France
State/province [20] 0 0
Dijon
Country [21] 0 0
France
State/province [21] 0 0
LAGNY SUR MARNE cedex
Country [22] 0 0
France
State/province [22] 0 0
Le Chesnay
Country [23] 0 0
France
State/province [23] 0 0
Le Coudray
Country [24] 0 0
France
State/province [24] 0 0
Lyon Cedex 04
Country [25] 0 0
France
State/province [25] 0 0
Lyon
Country [26] 0 0
France
State/province [26] 0 0
MARSEILLE cedex 15
Country [27] 0 0
France
State/province [27] 0 0
Marseille
Country [28] 0 0
France
State/province [28] 0 0
Massy
Country [29] 0 0
France
State/province [29] 0 0
Melun
Country [30] 0 0
France
State/province [30] 0 0
Montauban
Country [31] 0 0
France
State/province [31] 0 0
Montfermeil
Country [32] 0 0
France
State/province [32] 0 0
MONTREUIL Cedex
Country [33] 0 0
France
State/province [33] 0 0
Neuilly Sur Seine
Country [34] 0 0
France
State/province [34] 0 0
Nimes
Country [35] 0 0
France
State/province [35] 0 0
Paris Cedex 13
Country [36] 0 0
France
State/province [36] 0 0
PARIS Cedex 15
Country [37] 0 0
France
State/province [37] 0 0
Paris
Country [38] 0 0
France
State/province [38] 0 0
PESSAC Cedex
Country [39] 0 0
France
State/province [39] 0 0
Quincy sous Sénart
Country [40] 0 0
France
State/province [40] 0 0
Rouen Cedex
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France
State/province [41] 0 0
Strasbourg
Country [42] 0 0
France
State/province [42] 0 0
TOURS Cedex 9
Country [43] 0 0
France
State/province [43] 0 0
TOURS cedex
Country [44] 0 0
France
State/province [44] 0 0
VANNES cedex
Country [45] 0 0
Germany
State/province [45] 0 0
Bad Friedrichshall
Country [46] 0 0
Germany
State/province [46] 0 0
Bad Nauheim
Country [47] 0 0
Germany
State/province [47] 0 0
Darmstadt
Country [48] 0 0
Germany
State/province [48] 0 0
Esslingen
Country [49] 0 0
Germany
State/province [49] 0 0
Freiburg
Country [50] 0 0
Germany
State/province [50] 0 0
Gießen
Country [51] 0 0
Germany
State/province [51] 0 0
Hannover
Country [52] 0 0
Germany
State/province [52] 0 0
Ludwigshafen
Country [53] 0 0
Germany
State/province [53] 0 0
Lüdenscheid
Country [54] 0 0
Germany
State/province [54] 0 0
Mainz
Country [55] 0 0
Germany
State/province [55] 0 0
Merseburg
Country [56] 0 0
Germany
State/province [56] 0 0
Wuppertal
Country [57] 0 0
Hungary
State/province [57] 0 0
Budapest
Country [58] 0 0
Hungary
State/province [58] 0 0
Debrecen
Country [59] 0 0
Hungary
State/province [59] 0 0
Pécs
Country [60] 0 0
Hungary
State/province [60] 0 0
Szeged
Country [61] 0 0
Italy
State/province [61] 0 0
Arezzo
Country [62] 0 0
Italy
State/province [62] 0 0
Ascoli Piceno
Country [63] 0 0
Italy
State/province [63] 0 0
Cona
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Italy
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Forlì
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Italy
State/province [65] 0 0
Genova
Country [66] 0 0
Italy
State/province [66] 0 0
Grosseto
Country [67] 0 0
Italy
State/province [67] 0 0
Massa
Country [68] 0 0
Italy
State/province [68] 0 0
Seriate
Country [69] 0 0
Italy
State/province [69] 0 0
Siena
Country [70] 0 0
Netherlands
State/province [70] 0 0
Alkmaar
Country [71] 0 0
Netherlands
State/province [71] 0 0
Arnhem
Country [72] 0 0
Netherlands
State/province [72] 0 0
Den Bosch
Country [73] 0 0
Netherlands
State/province [73] 0 0
Terneuzen
Country [74] 0 0
Spain
State/province [74] 0 0
A Coruña
Country [75] 0 0
Spain
State/province [75] 0 0
Alicante
Country [76] 0 0
Spain
State/province [76] 0 0
Badalona
Country [77] 0 0
Spain
State/province [77] 0 0
Barcelona
Country [78] 0 0
Spain
State/province [78] 0 0
Hospitalet de Llobregat(Barcel
Country [79] 0 0
Spain
State/province [79] 0 0
Madrid
Country [80] 0 0
Spain
State/province [80] 0 0
Málaga
Country [81] 0 0
Spain
State/province [81] 0 0
Santiago(A Coruña)
Country [82] 0 0
Spain
State/province [82] 0 0
Sevilla
Country [83] 0 0
Spain
State/province [83] 0 0
Vigo(Pontevedra)
Country [84] 0 0
Sweden
State/province [84] 0 0
Gävle
Country [85] 0 0
Sweden
State/province [85] 0 0
Linköping
Country [86] 0 0
Sweden
State/province [86] 0 0
Uppsala
Country [87] 0 0
Sweden
State/province [87] 0 0
Örebro
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Ashford
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Belfast
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Cambridge
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Coventry
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Eastbourne
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Hastings
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Middlesborough
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Newcastle-Upon-Tyne
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Norwich
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01347580
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dr Judith Hsia, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications