Clinical trial NCT01813435: GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation
Official title: GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease (CAD)
Keywords: CAD
ACS
All comers
DAPT
PCI
Lead sponsor: ECRI bv
Sponsor class: INDUSTRY
Collaborators: name: Biosensors International
name: AstraZeneca
name: The Medicines Company
First posted: 2013-03-19
Enrollment: 15991
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After a stent procedure, it is common practice to prescribe anti-platelet medication to prevent the blood from clotting. The main objective of this study is to determine if there is a better medication strategy to prevent blood from clotting and at the same time minimising the number of complications.

There are two medication strategies:

* Study group: Dual anti-platelet therapy (ticagrelor combined with aspirin) for 1 month, and then ticagrelor alone for another 23 months OR
* Control group: Standard treatment, being dual anti-platelet therapy (ticagrelor or clopidogrel combined with aspirin) for 12 months, and then aspirin alone indefinitely

Detailed description: The study objective is to determine in all-comers patients undergoing percutaneous coronary intervention (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 myocardial infarction (MI) compared to treatment with 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.

The study design is an investigator-initiated, prospective randomised, multi-centre, multi-national, open-label trial to be conducted in approximately 60-80 interventional cardiology centres in Europe, North America, South America and Asia-Pacific. Patients will be randomised at a 1:1 ratio to study or reference treatment strategy.

Randomisation will occur at the time of the index procedure prior to PCI. Subjects will be stratified according to centre and according to the clinical presentation (Stable Coronary Artery Disease (CAD) vs. Acute Coronary Syndrome (ACS)).

All patients will be followed for a period of 2 years.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI)
timeFrame: 2 year
Secondary outcomes:
measure: Number of Participants With All-cause Mortality
timeFrame: 2-year
measure: Number of Participants With Myocardial Infarction
timeFrame: 2 year
measure: Number of Participants With New Q-wave Myocardial Infarction
timeFrame: 2-year
measure: Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction
timeFrame: 2-year
measure: Number of Participants With a Stroke
timeFrame: 2 year
measure: Number of Participants With a Myocardial Revascularisation
timeFrame: 2 year
measure: Number of Participants With a Definite Stent Thrombosis
timeFrame: 2 year
measure: Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding
timeFrame: 2 year
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Research centre Brisbane, 6101
city: Melbourne
country: Australia
facility: Research centre Melbourne, 6104
city: Melbourne
country: Australia
facility: Research centre Melbourne, 6105
city: Graz
country: Austria
facility: Research centre Graz, 4305
city: Innsbruck
country: Austria
facility: Rsearch centre Innsbruck, 4303
city: Linz
country: Austria
facility: Research centre Linz, 4304
city: Vienna
country: Austria
facility: Research centre Vienna, 4301
city: Vienna
country: Austria
facility: Research centre Vienna, 4302
city: Aalst
country: Belgium
facility: Research centre Aalst, 3201
city: Aalst
country: Belgium
facility: Research centre Aalst, 3206
city: Bonheiden
country: Belgium
facility: Research centre Bonheiden, 3204
city: Charleroi
country: Belgium
facility: Research centre Charleroi, 3202
city: Genk
country: Belgium
facility: Research centre Genk, 3205
city: Hasselt
country: Belgium
facility: Research centre Hasselt, 3203
city: Rio de Janeiro
country: Brazil
facility: Research centre Rio de Janeiro, 5503
city: Rio de Janeiro
country: Brazil
facility: Research centre Rio de Janeiro, 5504
city: Sao Paulo
country: Brazil
facility: Research centre Sao Paulo, 5501
city: Sao Paulo
country: Brazil
facility: Research centre Sao Paulo, 5502
city: Uberlândia
country: Brazil
facility: Research centre Uberlândia, 5505
city: Burgas
country: Bulgaria
facility: Research centre Burgas, 9902
city: Plovdiv
country: Bulgaria
facility: Research centre Plovdiv, 9905
city: Sofia
country: Bulgaria
facility: Research centre Sofia, 9901
city: Sofia
country: Bulgaria
facility: Research centre Sofia, 9903
city: Sofia
country: Bulgaria
facility: Research centre Sofia, 9904
city: Sofia
country: Bulgaria
facility: Research centre Sofia, 9907
city: Sofia
country: Bulgaria
facility: Research centre Sofia, 9908
city: Varna
country: Bulgaria
facility: Research centre Varna, 9906
city: Newmarket
country: Canada
facility: Research centre Newmarket, 1003
city: Quebec
country: Canada
facility: Research centre Quebec, 1001
city: Copenhagen
country: Denmark
facility: Research centre Copenhagen, 4501
city: Roskilde
country: Denmark
facility: Research centre Roskilde, 4503
city: Aix en Provence
country: France
facility: Research centre Aix en Provence, 3311
city: Caen
country: France
facility: Research centre Caen, 3308
city: Caen
country: France
facility: Research centre Caen, 3309
city: Clermont-Ferrand
country: France
facility: Research centre Clermont-Ferrand, 3303
city: Dijon
country: France
facility: Research centre Dijon, 3313
city: Grenoble Cedex
country: France
facility: Research centre Grenoble, 3312
city: Lyon
country: France
facility: Research centre Lyon, 3316
city: Nancy
country: France
facility: Research centre Nancy, 3314
city: Paris
country: France
facility: Research centre Paris, 3301
city: Paris
country: France
facility: Research centre Paris, 3305
city: Rouen
country: France
facility: Research centre Rouen, 3307
city: Saint Etienne
country: France
facility: Research centre Saint Etienne, 3310
city: Toulouse
country: France
facility: Research centre Toulouse, 3302
city: Bad Krozingen
country: Germany
facility: Research centre Bad Krozingen, 4904
city: Bad Nauheim
country: Germany
facility: Research centre Bad Nauheim, 4902
city: Berlin
country: Germany
facility: Research centre Berlin, 4918
city: Bonn
country: Germany
facility: Research centre Bonn, 4911
city: Dresden
country: Germany
facility: Research centre Dresden, 4908
city: Essen
country: Germany
facility: Research centre Essen, 4903
city: Fulda
country: Germany
facility: Research centre Fulda, 4905
city: Giessen
country: Germany
facility: Research centre Giessen 4901
city: Göttingen
country: Germany
facility: Research centre Göttingen, 4907
city: Landshut
country: Germany
facility: Research centre Landshut, 4909
city: Lubeck
country: Germany
facility: Research centre Lubeck, 4917
city: Mainz
country: Germany
facility: Research centre Mainz, 4910
city: Mannheim
country: Germany
facility: Research centre Mannheim, 4912
city: Mönchengladbach
country: Germany
facility: Research centre Mönchengladbach, 4915
city: Neuss
country: Germany
facility: Research centre Neuss, 4916
city: Tubingen
country: Germany
facility: Research centre Tubingen, 4914
city: Villingen - Schwenningen
country: Germany
facility: Research centre Villingen - Schwenningen, 4919
city: Balatonfüred
country: Hungary
facility: Research centre Balatonfüred, 3608
city: Budapest
country: Hungary
facility: Research centre Budapest, 3602
city: Budapest
country: Hungary
facility: Research centre Budapest, 3603
city: Debrecen
country: Hungary
facility: Research centre Debrecen, 3607
city: Gyula
country: Hungary
facility: Research centre Gyula, 3606
city: Nyíregyháza
country: Hungary
facility: Research centre Nyíregyháza, 3605
city: Pécs
country: Hungary
facility: Research centre Pécs, 3604
city: Szeged
country: Hungary
facility: Research centre szeged, 3601
city: Arezzo
country: Italy
facility: Research centre Arezzo, 3902
city: Brescia
country: Italy
facility: Research centre Brescia, 3912
city: Ferrara
country: Italy
facility: Research centre Ferrara, 3905
city: Milano
country: Italy
facility: Research centre Milano, 3901
city: Pavia
country: Italy
facility: Research centre Pavia, 3903
city: Terni
country: Italy
facility: Research centre Terni, 3909
city: Alkmaar
country: Netherlands
facility: Research centre Alkmaar, 3106
city: Amsterdam
country: Netherlands
facility: OLVG Research centre Amsterdam, 3104
city: Groningen
country: Netherlands
facility: UMCG Groningen, 3108
city: Leeuwarden
country: Netherlands
facility: Research centre Leeuwarden, 3102
city: Nieuwegein
country: Netherlands
facility: Research centre Nieuwegein, 3107
city: Nijmegen
country: Netherlands
facility: Research centre Nijmegen, 3105
city: Rotterdam
country: Netherlands
facility: EMC Rotterdam, 3101
city: Rotterdam
country: Netherlands
facility: Maasstad Rotterdam, 3103
city: Tilburg
country: Netherlands
facility: Research centre Tilburg, 3109
city: Chrzanow
country: Poland
facility: Research centre Chrzanow, 4802
city: Dabrowa Gornicza
country: Poland
facility: Research centre Dabrowa Gornicza, 4801
city: Kedzierzyn-Kozle
country: Poland
facility: Research centre Kedzierzyn-Kozle, 4805
city: Krakov
country: Poland
facility: Research centre Krakov, 4807
city: Mielec
country: Poland
facility: Research centre Mielec, 4809
city: Nysa
country: Poland
facility: Research centre Nysa, 4808
city: Ustroń
country: Poland
facility: Research centre Ustroń, 4803
city: Gaia
country: Portugal
facility: Research centre Gaia, 3501
city: Lisbon
country: Portugal
facility: Research centre Lisbon, 3503
city: Lisbon
country: Portugal
facility: Research centre Lisbon, 3504
city: Lisbon
country: Portugal
facility: Research centre Lisbon, 3505
city: Singapore
country: Singapore
facility: Research centre Singapore, 6501
city: Singapore
country: Singapore
facility: Research centre Singapore, 6502
city: Barcelona
country: Spain
facility: Research centre Barcelona, 3401
city: Barcelona
country: Spain
facility: Research centre Barcelona, 3403
city: Barcelona
country: Spain
facility: Research centre Barcelona, 3405
city: Huelva
country: Spain
facility: Research centre Huelva, 3408
city: Madrid
country: Spain
facility: Research centre Madrid 3410
city: Madrid
country: Spain
facility: Research centre Madrid, 3402
city: Madrid
country: Spain
facility: Research centre Madrid, 3407
city: Madrid
country: Spain
facility: Research centre Madrid, 3409
city: Vigo
country: Spain
facility: Research centre Vigo, 3404
city: Bern
country: Switzerland
facility: Research centre Bern, 4106
city: Bern
country: Switzerland
facility: Research centre Bern, 4107
city: Geneva
country: Switzerland
facility: Research centre Geneva, 4101
city: Lausanne
country: Switzerland
facility: Research centre Lausanne, 4104
city: Liestal
country: Switzerland
facility: Research centre Liestal, 4108
city: Lugano
country: Switzerland
facility: Research centre Lugano, 4105
city: Belfast
country: United Kingdom
facility: Research centre Belfast, 4420
city: Belfast
country: United Kingdom
facility: Research Centre Belfast, 4423
city: Blackburn
country: United Kingdom
facility: Research centre Blackburn, 4404
city: Blackpool
country: United Kingdom
facility: Research centre Blackpool, 4408
city: Bournemouth
country: United Kingdom
facility: Research centre Bournemouth, 4418
city: Brighton
country: United Kingdom
facility: Research centre Brighton, 4405
city: Cambridge
country: United Kingdom
facility: Research centre Cambridge, 4417
city: Cardiff
country: United Kingdom
facility: Research centre Cardiff, 4402
city: Glasgow
country: United Kingdom
facility: Research centre Glasgow, 4407
city: Leicester
country: United Kingdom
facility: Research centre Leicester, 4421
city: Liverpool
country: United Kingdom
facility: Research centre Liverpool, 4001
city: Manchester
country: United Kingdom
facility: Research centre Manchester, 4403
city: Manchester
country: United Kingdom
facility: Research centre Manchester, 4406
city: Newcastle
country: United Kingdom
facility: Research centre Newcastle, 4413
city: Rhyl
country: United Kingdom
facility: Research centre Rhyl, 4414
city: Southampton
country: United Kingdom
facility: Research centre Southampton, 4415
city: Stevenage
country: United Kingdom
facility: Research centre Stevenage, 4412
city: Wolverhampton
country: United Kingdom
facility: Research centre Wolverhampton, 4422
Study officials:
affiliation: European Cardiovascular Research Institute
name: Ernest Spitzer, MD
role: STUDY_DIRECTOR
affiliation: Inselspital, University Hospital Bern, Switzerland
name: Stephan Windecker, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vranckx P, Valgimigli M, Juni P, Hamm C, Steg PG, Heg D, van Es GA, McFadden EP, Onuma Y, van Meijeren C, Chichareon P, Benit E, Mollmann H, Janssens L, Ferrario M, Moschovitis A, Zurakowski A, Dominici M, Van Geuns RJ, Huber K, Slagboom T, Serruys PW, Windecker S; GLOBAL LEADERS Investigators. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial. Lancet. 2018 Sep 15;392(10151):940-949. doi: 10.1016/S0140-6736(18)31858-0. Epub 2018 Aug 27.
citation: Ono M, Hara H, Kawashima H, Gao C, Wang R, Wykrzykowska JJ, Piek JJ, Garg S, Hamm C, Steg PG, Valgimigli M, Windecker S, Vranckx P, Onuma Y, Serruys PW. Ticagrelor monotherapy versus aspirin monotherapy at 12 months after percutaneous coronary intervention: a landmark analysis of the GLOBAL LEADERS trial. EuroIntervention. 2022 Aug 5;18(5):e377-e388. doi: 10.4244/EIJ-D-21-00870.
citation: Gragnano F, Zwahlen M, Vranckx P, Heg D, Schmidlin K, Hamm C, Steg PG, Gargiulo G, McFadden EP, Onuma Y, Chichareon P, Benit E, Mollmann H, Janssens L, Leonardi S, Zurakowski A, Arrivi A, Van Geuns RJ, Huber K, Slagboom T, Calabro P, Serruys PW, Juni P, Valgimigli M, Windecker S; GLOBAL LEADERS Investigators [Link]. Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation: Per-Protocol Analysis of the GLOBAL LEADERS Trial. J Am Heart Assoc. 2022 May 17;11(10):e024291. doi: 10.1161/JAHA.121.024291. Epub 2022 Mar 1.
citation: Westra J, Eftekhari A, Renkens M, Mejia-Renteria H, Sejr-Hansen M, Stegehuis V, Holm NR, de Winter RJ, Piek JJ, Escaned J, Wykrzykowska JJ, Christiansen EH. Characterization of quantitative flow ratio and fractional flow reserve discordance using doppler flow and clinical follow-up. Int J Cardiovasc Imaging. 2022 Jun;38(6):1181-1190. doi: 10.1007/s10554-022-02522-1. Epub 2022 Jan 18.
citation: Vranckx P, Valgimigli M, Odutayo A, Serruys PW, Hamm C, Steg PG, Heg D, Mc Fadden EP, Onuma Y, Benit E, Janssens L, Diletti R, Ferrario M, Huber K, Raber L, Windecker S, Juni P; GLOBAL LEADERS Investigators. Efficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre-Specified Analysis of the GLOBAL LEADERS Trial. J Am Heart Assoc. 2021 Sep 21;10(18):e015560. doi: 10.1161/JAHA.119.015560. Epub 2021 Sep 17.
citation: Gao C, Tomaniak M, Takahashi K, Kawashima H, Wang R, Hara H, Ono M, Montalescot G, Garg S, Haude M, Slagboom T, Vranckx P, Valgimigli M, Windecker S, van Geuns RJ, Hamm C, Steg PG, Onuma Y, Angiolillo DJ, Serruys PW. Ticagrelor monotherapy in patients with concomitant diabetes mellitus and chronic kidney disease: a post hoc analysis of the GLOBAL LEADERS trial. Cardiovasc Diabetol. 2020 Oct 16;19(1):179. doi: 10.1186/s12933-020-01153-x.
citation: Kawashima H, Tomaniak M, Ono M, Wang R, Hara H, Gao C, Takahashi K, Sharif F, Thury A, Suryapranata H, Walsh S, Cotton J, Carrie D, Sabate M, Steinwender C, Leibundgut G, Wykrzykowska J, de Winter RJ, Garg S, Hamm C, Steg PG, Juni P, Vranckx P, Valgimigli M, Windecker S, Onuma Y, Serruys PW. Safety and Efficacy of 1-Month Dual Antiplatelet Therapy (Ticagrelor + Aspirin) Followed by 23-Month Ticagrelor Monotherapy in Patients Undergoing Staged Percutaneous Coronary Intervention (A Sub-Study from GLOBAL LEADERS). Am J Cardiol. 2021 Jan 1;138:1-10. doi: 10.1016/j.amjcard.2020.09.057. Epub 2020 Oct 13.
citation: Gao C, Takahashi K, Garg S, Hara H, Wang R, Kawashima H, Ono M, Montalescot G, Haude M, Slagboom T, Vranckx P, Valgimigli M, Windecker S, Hamm C, Steg PG, Storey R, van Geuns RJ, Tao L, Onuma Y, Serruys PW. Regional variation in patients and outcomes in the GLOBAL LEADERS trial. Int J Cardiol. 2021 Feb 1;324:30-37. doi: 10.1016/j.ijcard.2020.09.039. Epub 2020 Sep 15.
citation: Hara H, Takahashi K, Kogame N, Tomaniak M, Kerkmeijer LSM, Ono M, Kawashima H, Wang R, Gao C, Wykrzykowska JJ, de Winter RJ, Neumann FJ, Plante S, Lemos Neto PA, Garg S, Juni P, Vranckx P, Windecker S, Valgimigli M, Hamm C, Steg PG, Onuma Y, Serruys PW. Impact of Bleeding and Myocardial Infarction on Mortality in All-Comer Patients Undergoing Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2020 Sep;13(9):e009177. doi: 10.1161/CIRCINTERVENTIONS.120.009177. Epub 2020 Aug 25.
citation: Hara H, van Klaveren D, Takahashi K, Kogame N, Chichareon P, Modolo R, Tomaniak M, Ono M, Kawashima H, Wang R, Gao C, Niethammer M, Fontos G, Angioi M, Ribeiro VG, Barbato E, Leandro S, Hamm C, Valgimigli M, Windecker S, Juni P, Steg PG, Verbeeck J, Tijssen JGP, Sharif F, Onuma Y, Serruys PW; GLOBAL LEADERS Trial Investigators. Comparative Methodological Assessment of the Randomized GLOBAL LEADERS Trial Using Total Ischemic and Bleeding Events. Circ Cardiovasc Qual Outcomes. 2020 Aug;13(8):e006660. doi: 10.1161/CIRCOUTCOMES.120.006660. Epub 2020 Jul 30.
citation: Ono M, Chichareon P, Tomaniak M, Kawashima H, Takahashi K, Kogame N, Modolo R, Hara H, Gao C, Wang R, Walsh S, Suryapranata H, da Silva PC, Cotton J, Koning R, Akin I, Rensing BJWM, Garg S, Wykrzykowska JJ, Piek JJ, Juni P, Hamm C, Steg PG, Valgimigli M, Windecker S, Storey RF, Onuma Y, Vranckx P, Serruys PW. The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial. Clin Res Cardiol. 2020 Sep;109(9):1125-1139. doi: 10.1007/s00392-020-01604-1. Epub 2020 Jan 31.
citation: Tomaniak M, Chichareon P, Klimczak-Tomaniak D, Takahashi K, Kogame N, Modolo R, Wang R, Ono M, Hara H, Gao C, Kawashima H, Rademaker-Havinga T, Garg S, Curzen N, Haude M, Kochman J, Gori T, Montalescot G, Angiolillo DJ, Capodanno D, Storey RF, Hamm C, Vranckx P, Valgimigli M, Windecker S, Onuma Y, Serruys PW, Anderson R. Impact of renal function on clinical outcomes after PCI in ACS and stable CAD patients treated with ticagrelor: a prespecified analysis of the GLOBAL LEADERS randomized clinical trial. Clin Res Cardiol. 2020 Jul;109(7):930-943. doi: 10.1007/s00392-019-01586-9. Epub 2020 Jan 10.
citation: Tomaniak M, Chichareon P, Takahashi K, Kogame N, Modolo R, Chang CC, Spitzer E, Neumann FJ, Plante S, Hernandez Antolin R, Jambrik Z, Gelev V, Brunel P, Konteva M, Beygui F, Morelle JF, Filipiak KJ, van Geuns RJ, Soliman O, Tijssen J, Rademaker-Havinga T, Storey RF, Hamm C, Steg PG, Windecker S, Onuma Y, Valgimigli M, Serruys PW; GLOBAL LEADERS Study Investigators. Impact of chronic obstructive pulmonary disease and dyspnoea on clinical outcomes in ticagrelor treated patients undergoing percutaneous coronary intervention in the randomized GLOBAL LEADERS trial. Eur Heart J Cardiovasc Pharmacother. 2020 Jul 1;6(4):222-230. doi: 10.1093/ehjcvp/pvz052.
citation: Tomaniak M, Chichareon P, Modolo R, Takahashi K, Chang CC, Kogame N, Spitzer E, Buszman PE, van Geuns RM, Valkov V, Steinwender C, Geisler T, Prokopczuk J, Sabate M, Zmudka K, Rademaker-Havinga T, Tijssen JGP, Juni P, Hamm C, Steg PG, Onuma Y, Vranckx P, Valgimigli M, Windecker S, Baber U, Anderson R, Dominici M, Serruys PW. Ticagrelor monotherapy beyond one month after PCI in ACS or stable CAD in elderly patients: a pre-specified analysis of the GLOBAL LEADERS trial. EuroIntervention. 2020 Apr 3;15(18):e1605-e1614. doi: 10.4244/EIJ-D-19-00699.
citation: Chichareon P, Modolo R, Kerkmeijer L, Tomaniak M, Kogame N, Takahashi K, Chang CC, Komiyama H, Moccetti T, Talwar S, Colombo A, Maillard L, Barlis P, Wykrzykowska J, Piek JJ, Garg S, Hamm C, Steg PG, Juni P, Valgimigli M, Windecker S, Onuma Y, Mehran R, Serruys PW. Association of Sex With Outcomes in Patients Undergoing Percutaneous Coronary Intervention: A Subgroup Analysis of the GLOBAL LEADERS Randomized Clinical Trial. JAMA Cardiol. 2020 Jan 1;5(1):21-29. doi: 10.1001/jamacardio.2019.4296.
citation: Takahashi K, Serruys PW, Chichareon P, Chang CC, Tomaniak M, Modolo R, Kogame N, Magro M, Chowdhary S, Eitel I, Zweiker R, Ong P, Ottesen MM, Tijssen JGP, Wykrzykowska JJ, de Winter RJ, Garg S, Stoll HP, Hamm C, Steg PG, Onuma Y, Valgimigli M, Vranckx P, Carrie D, Windecker S. Efficacy and Safety of Ticagrelor Monotherapy in Patients Undergoing Multivessel PCI. J Am Coll Cardiol. 2019 Oct 22;74(16):2015-2027. doi: 10.1016/j.jacc.2019.08.997.
citation: Tomaniak M, Chichareon P, Onuma Y, Deliargyris EN, Takahashi K, Kogame N, Modolo R, Chang CC, Rademaker-Havinga T, Storey RF, Dangas GD, Bhatt DL, Angiolillo DJ, Hamm C, Valgimigli M, Windecker S, Steg PG, Vranckx P, Serruys PW; GLOBAL LEADERS Trial Investigators. Benefit and Risks of Aspirin in Addition to Ticagrelor in Acute Coronary Syndromes: A Post Hoc Analysis of the Randomized GLOBAL LEADERS Trial. JAMA Cardiol. 2019 Nov 1;4(11):1092-1101. doi: 10.1001/jamacardio.2019.3355.
citation: Serruys PW, Tomaniak M, Chichareon P, Modolo R, Kogame N, Takahashi K, Chang CC, Spitzer E, Walsh SJ, Adlam D, Hildick-Smith D, Edes I, van de Harst P, Krackhardt F, Tijssen JGP, Rademaker-Havinga T, Garg S, Steg PG, Hamm C, Juni P, Vranckx P, Onuma Y, Verheugt FWA. Patient-oriented composite endpoints and net adverse clinical events with ticagrelor monotherapy following percutaneous coronary intervention: insights from the randomised GLOBAL LEADERS trial. EuroIntervention. 2019 Dec 20;15(12):e1090-e1098. doi: 10.4244/EIJ-D-19-00202.
citation: Leonardi S, Franzone A, Piccolo R, McFadden E, Vranckx P, Serruys P, Benit E, Liebetrau C, Janssens L, Ferrario M, Zurakowski A, van Geuns RJ, Dominici M, Huber K, Slagboom T, Buszman P, Bolognese L, Tumscitz C, Bryniarski K, Aminian A, Vrolix M, Petrov I, Garg S, Naber C, Prokopczuk J, Hamm C, Steg G, Heg D, Juni P, Windecker S, Valgimigli M. Rationale and design of a prospective substudy of clinical endpoint adjudication processes within an investigator-reported randomised controlled trial in patients with coronary artery disease: the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY). BMJ Open. 2019 Mar 9;9(3):e026053. doi: 10.1136/bmjopen-2018-026053.