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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
Timepoint [1] 0 0
At initial angiography, pre PCI
Primary outcome [2] 0 0
ST-segment Elevation Resolution Pre PCI =70% (Co-primary Endpoint)
Timepoint [2] 0 0
Between baseline and PCI
Secondary outcome [1] 0 0
1st Composite Clinical Endpoint
Timepoint [1] 0 0
during the 30 days of treatment
Secondary outcome [2] 0 0
2nd Composite Clinical Endpoint
Timepoint [2] 0 0
within 30 days of study
Secondary outcome [3] 0 0
Definite Stent Thrombosis
Timepoint [3] 0 0
during 30 days of treatment
Secondary outcome [4] 0 0
TIMI Flow Grade 3 Post -PCI
Timepoint [4] 0 0
at coroangiography post-PCI
Secondary outcome [5] 0 0
ST Segment Elevation Resolution Post-PCI >= 70%
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
Timepoint [6] 0 0
during PCI
Secondary outcome [7] 0 0
Major Bleeds Within 48 Hours
Timepoint [7] 0 0
within 48 hours of first dose
Secondary outcome [8] 0 0
Minor and Major Bleedings Within 48 Hours
Timepoint [8] 0 0
within 48 hours of first dose
Secondary outcome [9] 0 0
Major Bleeds After 48 Hours
Timepoint [9] 0 0
after 48hours post-first dose
Secondary outcome [10] 0 0
Minor and Major Bleeds After 48 Hours
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
Sex
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
1/09/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2013
Sample size
Target
Accrual to date
Final
1875
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
Country [41] 0 0
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
Country [64] 0 0
Italy
State/province [64] 0 0
Forlì
Country [65] 0 0
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Montalescot G, van 't Hof AW, Lapostolle F, Silvai... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT01347580