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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01813435




Registration number
NCT01813435
Ethics application status
Date submitted
12/02/2013
Date registered
19/03/2013

Titles & IDs
Public title
GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation
Scientific title
GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation
Secondary ID [1] 0 0
ECRI-12-001, 02EU11
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease (CAD) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

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

Experimental: Experimental treatment strategy - All patients in the treatment group will receive acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy.

Dosage and frequency:

Ticagrelor: 90 mg b.i.d. ASA: of 75mg qd (- = 100 mg qd)

Active comparator: Reference treatment strategy - Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.

Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.

Dosage and frequency:

Brilique(Ticagrelor): 90 mg b.i.d. ASA: of 75mg qd (- = 100 mg qd) Clopidogrel: 75 mg qd


Treatment: Drugs: Ticagrelor
Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.

Treatment: Drugs: Acetylsalicylic Acid
Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy

Treatment: Drugs: Clopidogrel
Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.

Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI)
Timepoint [1] 0 0
2 year
Secondary outcome [1] 0 0
Number of Participants With All-cause Mortality
Timepoint [1] 0 0
2-year
Secondary outcome [2] 0 0
Number of Participants With Myocardial Infarction
Timepoint [2] 0 0
2 year
Secondary outcome [3] 0 0
Number of Participants With New Q-wave Myocardial Infarction
Timepoint [3] 0 0
2-year
Secondary outcome [4] 0 0
Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction
Timepoint [4] 0 0
2-year
Secondary outcome [5] 0 0
Number of Participants With a Stroke
Timepoint [5] 0 0
2 year
Secondary outcome [6] 0 0
Number of Participants With a Myocardial Revascularisation
Timepoint [6] 0 0
2 year
Secondary outcome [7] 0 0
Number of Participants With a Definite Stent Thrombosis
Timepoint [7] 0 0
2 year
Secondary outcome [8] 0 0
Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding
Timepoint [8] 0 0
2 year

Eligibility
Key inclusion criteria
-"All comer" patients

1. Age =18 years;
2. Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. The vessel should have a reference vessel diameter of at least 2.25 mm (no limitation on the number of treated lesions, vessels, or lesion length);
3. Able to provide informed consent and willing to participate in 2 year follow- up period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known intolerance to aspirin, P2Y12 inhibitors, bivalirudin, stainless steel or biolimus;
2. Known intake of a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir), as co-administration may lead to a substantial increase in exposure to ticagrelor;
3. Known moderate to severe hepatic impairment (alanine-aminotransferase = 3 x ULN);
4. Planned surgery, including coronary artery bypass graft (CABG) as a staged procedure (hybrid) within 12 months of the index procedure, unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
5. Need for chronic oral anti-coagulation therapy;
6. Active major bleeding or major surgery within the last 30 days;
7. Known history of intracranial haemorrhagic stroke or intra-cranial aneurysm;
8. Known stroke (any type) within the last 30 days;
9. Known pregnancy at time of randomisation;
10. Female who is breastfeeding at time of randomisation;
11. Currently participating in another trial and not yet at its primary endpoint.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
1/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/04/2018
Sample size
Target
Accrual to date
Final
15991
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research centre Brisbane, 6101 - Brisbane
Recruitment hospital [2] 0 0
Research centre Melbourne, 6104 - Melbourne
Recruitment hospital [3] 0 0
Research centre Melbourne, 6105 - Melbourne
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Linz
Country [4] 0 0
Austria
State/province [4] 0 0
Vienna
Country [5] 0 0
Belgium
State/province [5] 0 0
Aalst
Country [6] 0 0
Belgium
State/province [6] 0 0
Bonheiden
Country [7] 0 0
Belgium
State/province [7] 0 0
Charleroi
Country [8] 0 0
Belgium
State/province [8] 0 0
Genk
Country [9] 0 0
Belgium
State/province [9] 0 0
Hasselt
Country [10] 0 0
Brazil
State/province [10] 0 0
Rio de Janeiro
Country [11] 0 0
Brazil
State/province [11] 0 0
Sao Paulo
Country [12] 0 0
Brazil
State/province [12] 0 0
Uberlândia
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Burgas
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Plovdiv
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Sofia
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Varna
Country [17] 0 0
Canada
State/province [17] 0 0
Newmarket
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Denmark
State/province [19] 0 0
Copenhagen
Country [20] 0 0
Denmark
State/province [20] 0 0
Roskilde
Country [21] 0 0
France
State/province [21] 0 0
Aix en Provence
Country [22] 0 0
France
State/province [22] 0 0
Caen
Country [23] 0 0
France
State/province [23] 0 0
Clermont-Ferrand
Country [24] 0 0
France
State/province [24] 0 0
Dijon
Country [25] 0 0
France
State/province [25] 0 0
Grenoble Cedex
Country [26] 0 0
France
State/province [26] 0 0
Lyon
Country [27] 0 0
France
State/province [27] 0 0
Nancy
Country [28] 0 0
France
State/province [28] 0 0
Paris
Country [29] 0 0
France
State/province [29] 0 0
Rouen
Country [30] 0 0
France
State/province [30] 0 0
Saint Etienne
Country [31] 0 0
France
State/province [31] 0 0
Toulouse
Country [32] 0 0
Germany
State/province [32] 0 0
Bad Krozingen
Country [33] 0 0
Germany
State/province [33] 0 0
Bad Nauheim
Country [34] 0 0
Germany
State/province [34] 0 0
Berlin
Country [35] 0 0
Germany
State/province [35] 0 0
Bonn
Country [36] 0 0
Germany
State/province [36] 0 0
Dresden
Country [37] 0 0
Germany
State/province [37] 0 0
Essen
Country [38] 0 0
Germany
State/province [38] 0 0
Fulda
Country [39] 0 0
Germany
State/province [39] 0 0
Giessen
Country [40] 0 0
Germany
State/province [40] 0 0
Göttingen
Country [41] 0 0
Germany
State/province [41] 0 0
Landshut
Country [42] 0 0
Germany
State/province [42] 0 0
Lubeck
Country [43] 0 0
Germany
State/province [43] 0 0
Mainz
Country [44] 0 0
Germany
State/province [44] 0 0
Mannheim
Country [45] 0 0
Germany
State/province [45] 0 0
Mönchengladbach
Country [46] 0 0
Germany
State/province [46] 0 0
Neuss
Country [47] 0 0
Germany
State/province [47] 0 0
Tubingen
Country [48] 0 0
Germany
State/province [48] 0 0
Villingen - Schwenningen
Country [49] 0 0
Hungary
State/province [49] 0 0
Balatonfüred
Country [50] 0 0
Hungary
State/province [50] 0 0
Budapest
Country [51] 0 0
Hungary
State/province [51] 0 0
Debrecen
Country [52] 0 0
Hungary
State/province [52] 0 0
Gyula
Country [53] 0 0
Hungary
State/province [53] 0 0
Nyíregyháza
Country [54] 0 0
Hungary
State/province [54] 0 0
Pécs
Country [55] 0 0
Hungary
State/province [55] 0 0
Szeged
Country [56] 0 0
Italy
State/province [56] 0 0
Arezzo
Country [57] 0 0
Italy
State/province [57] 0 0
Brescia
Country [58] 0 0
Italy
State/province [58] 0 0
Ferrara
Country [59] 0 0
Italy
State/province [59] 0 0
Milano
Country [60] 0 0
Italy
State/province [60] 0 0
Pavia
Country [61] 0 0
Italy
State/province [61] 0 0
Terni
Country [62] 0 0
Netherlands
State/province [62] 0 0
Alkmaar
Country [63] 0 0
Netherlands
State/province [63] 0 0
Amsterdam
Country [64] 0 0
Netherlands
State/province [64] 0 0
Groningen
Country [65] 0 0
Netherlands
State/province [65] 0 0
Leeuwarden
Country [66] 0 0
Netherlands
State/province [66] 0 0
Nieuwegein
Country [67] 0 0
Netherlands
State/province [67] 0 0
Nijmegen
Country [68] 0 0
Netherlands
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Rotterdam
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Netherlands
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Tilburg
Country [70] 0 0
Poland
State/province [70] 0 0
Chrzanow
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Poland
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Dabrowa Gornicza
Country [72] 0 0
Poland
State/province [72] 0 0
Kedzierzyn-Kozle
Country [73] 0 0
Poland
State/province [73] 0 0
Krakov
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Poland
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Mielec
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Poland
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Nysa
Country [76] 0 0
Poland
State/province [76] 0 0
Ustron
Country [77] 0 0
Portugal
State/province [77] 0 0
Gaia
Country [78] 0 0
Portugal
State/province [78] 0 0
Lisbon
Country [79] 0 0
Singapore
State/province [79] 0 0
Singapore
Country [80] 0 0
Spain
State/province [80] 0 0
Barcelona
Country [81] 0 0
Spain
State/province [81] 0 0
Huelva
Country [82] 0 0
Spain
State/province [82] 0 0
Madrid
Country [83] 0 0
Spain
State/province [83] 0 0
Vigo
Country [84] 0 0
Switzerland
State/province [84] 0 0
Bern
Country [85] 0 0
Switzerland
State/province [85] 0 0
Geneva
Country [86] 0 0
Switzerland
State/province [86] 0 0
Lausanne
Country [87] 0 0
Switzerland
State/province [87] 0 0
Liestal
Country [88] 0 0
Switzerland
State/province [88] 0 0
Lugano
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Belfast
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Blackburn
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Blackpool
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Bournemouth
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Brighton
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Cambridge
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Cardiff
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Glasgow
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Leicester
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Liverpool
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Manchester
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Newcastle
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Rhyl
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Southampton
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Stevenage
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ECRI bv
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Biosensors International
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
AstraZeneca
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
The Medicines Company
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ernest Spitzer, MD
Address 0 0
European Cardiovascular Research Institute
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01813435