Clinical Trial Results:
GLOBAL LEADERS: Comparative effectiveness of 1 month of ticagrelor plus aspirin followed by ticagrelor monotherapy versus a current-day intensive dual antiplatelet therapy in all-comers patients undergoing percutaneous coronary intervention with bivalirudin and BioMatrix family drug-eluting stent use.
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Summary
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EudraCT number |
2012-003515-58 |
Trial protocol |
IT DE GB AT ES BE NL DK HU PT BG |
Global end of trial date |
16 Feb 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Feb 2019
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First version publication date |
17 Feb 2019
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Other versions |
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Summary report(s) |
Global Leaders main paper Global leaders supplementary appendix |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ECRI-12-001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01813435 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
ECRI b.v.
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Sponsor organisation address |
Westblaak 98, Rotterdam, Netherlands,
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Public contact |
Managing Director, ECRI b.v., 0031 0102062850, GA.vEs@ecri-trials.com
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Scientific contact |
Managing Director, ECRI b.v., 0031 0102062850, GA.vEs@ecri-trials.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
16 Feb 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
16 Feb 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Feb 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To determine in all-comers patients undergoing PCI under standardised treatment (including the BioMatrix family of drug-eluting stents and bivalirudin), whether treatment with 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy is superior with respect to the composite of all-cause mortality or non-fatal new Q-wave MI compared to treatment with 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
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Protection of trial subjects |
NA, phase IV trial
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 May 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 1159
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Country: Number of subjects enrolled |
Poland: 1532
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Country: Number of subjects enrolled |
Portugal: 113
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Country: Number of subjects enrolled |
Spain: 951
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Country: Number of subjects enrolled |
United Kingdom: 1713
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Country: Number of subjects enrolled |
Austria: 672
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Country: Number of subjects enrolled |
Belgium: 2185
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Country: Number of subjects enrolled |
Bulgaria: 943
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Country: Number of subjects enrolled |
Denmark: 131
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Country: Number of subjects enrolled |
France: 849
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Country: Number of subjects enrolled |
Germany: 2267
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Country: Number of subjects enrolled |
Hungary: 527
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Country: Number of subjects enrolled |
Italy: 1578
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Country: Number of subjects enrolled |
Switzerland: 705
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Country: Number of subjects enrolled |
Australia: 83
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Country: Number of subjects enrolled |
Brazil: 248
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Country: Number of subjects enrolled |
Singapore: 142
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Country: Number of subjects enrolled |
Canada: 170
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Worldwide total number of subjects |
15968
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EEA total number of subjects |
14620
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
7877
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From 65 to 84 years |
7854
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85 years and over |
237
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Recruitment
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Recruitment details |
- | |||||||||
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Pre-assignment
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Screening details |
please refer to the manuscript for screening details | |||||||||
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Period 1
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Period 1 title |
overall trail (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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experimental intervention group | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
dual antiplatelet regimen for 30 days after revasc
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
NA
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Arm title
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control group | |||||||||
Arm description |
- | |||||||||
Arm type |
control | |||||||||
Investigational medicinal product name |
dual antiplatelet regimen for 365 days after revasc
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
NA
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Baseline characteristics reporting groups
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Reporting group title |
overall trail
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
experimental intervention group
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Reporting group description |
- | ||
Reporting group title |
control group
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Reporting group description |
- | ||
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End point title |
all-casue mortality or new Q-wave myocardial infarction | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
up to 2 years post randomisation
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Statistical analysis title |
primary endpoint | |||||||||
Comparison groups |
experimental intervention group v control group
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Number of subjects included in analysis |
15968
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | |||||||||
P-value |
< 0.001 | |||||||||
Method |
Mantel-Cox | |||||||||
Confidence interval |
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| Notes [1] - Mantel-Cox method |
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Adverse events information [1]
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Timeframe for reporting adverse events |
AE needed to be reported from ICF signature until last follow-up visit
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
20.0
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| Frequency threshold for reporting non-serious adverse events: 0% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: see results in manuscript |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
