GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation
1 other identifier
interventional
15,991
17 countries
127
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2013
Longer than P75 for phase_3
127 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2013
CompletedFirst Posted
Study publicly available on registry
March 19, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2018
CompletedResults Posted
Study results publicly available
July 5, 2019
CompletedMarch 15, 2022
March 1, 2022
2.4 years
February 12, 2013
December 21, 2018
March 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI)
Number of Participants with a composite of all-cause mortality or non-fatal new Q-wave MI up to 2 years post randomisation.
2 year
Secondary Outcomes (8)
Number of Participants With All-cause Mortality
2-year
Number of Participants With Myocardial Infarction
2 year
Number of Participants With New Q-wave Myocardial Infarction
2-year
Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction
2-year
Number of Participants With a Stroke
2 year
- +3 more secondary outcomes
Study Arms (2)
Experimental treatment strategy
EXPERIMENTALAll 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)
Reference treatment strategy
ACTIVE COMPARATORAcute 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
Interventions
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.
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
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
Eligibility Criteria
You may qualify if:
- "All comer" patients
- Age ≥18 years;
- 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);
- Able to provide informed consent and willing to participate in 2 year follow- up period.
You may not qualify if:
- Known intolerance to aspirin, P2Y12 inhibitors, bivalirudin, stainless steel or biolimus;
- 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;
- Known moderate to severe hepatic impairment (alanine-aminotransferase ≥ 3 x ULN);
- 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;
- Need for chronic oral anti-coagulation therapy;
- Active major bleeding or major surgery within the last 30 days;
- Known history of intracranial haemorrhagic stroke or intra-cranial aneurysm;
- Known stroke (any type) within the last 30 days;
- Known pregnancy at time of randomisation;
- Female who is breastfeeding at time of randomisation;
- Currently participating in another trial and not yet at its primary endpoint.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ECRI bvlead
- Biosensors Internationalcollaborator
- AstraZenecacollaborator
- The Medicines Companycollaborator
Study Sites (130)
Research centre Brisbane, 6101
Brisbane, Australia
Research centre Melbourne, 6104
Melbourne, Australia
Research centre Melbourne, 6105
Melbourne, Australia
Research centre Graz, 4305
Graz, Austria
Rsearch centre Innsbruck, 4303
Innsbruck, Austria
Research centre Linz, 4304
Linz, Austria
Research centre Vienna, 4301
Vienna, Austria
Research centre Vienna, 4302
Vienna, Austria
Research centre Aalst, 3201
Aalst, Belgium
Research centre Aalst, 3206
Aalst, Belgium
Research centre Bonheiden, 3204
Bonheiden, Belgium
Research centre Charleroi, 3202
Charleroi, Belgium
Research centre Genk, 3205
Genk, Belgium
Research centre Hasselt, 3203
Hasselt, Belgium
Research centre Rio de Janeiro, 5503
Rio de Janeiro, Brazil
Research centre Rio de Janeiro, 5504
Rio de Janeiro, Brazil
Research centre Sao Paulo, 5501
SĂ£o Paulo, Brazil
Research centre Sao Paulo, 5502
SĂ£o Paulo, Brazil
Research centre UberlĂ¢ndia, 5505
UberlĂ¢ndia, Brazil
Research centre Burgas, 9902
Burgas, Bulgaria
Research centre Plovdiv, 9905
Plovdiv, Bulgaria
Research centre Sofia, 9901
Sofia, Bulgaria
Research centre Sofia, 9903
Sofia, Bulgaria
Research centre Sofia, 9904
Sofia, Bulgaria
Research centre Sofia, 9907
Sofia, Bulgaria
Research centre Sofia, 9908
Sofia, Bulgaria
Research centre Varna, 9906
Varna, Bulgaria
Research centre Newmarket, 1003
Newmarket, Canada
Research centre Quebec, 1001
Québec, Canada
Research centre Copenhagen, 4501
Copenhagen, Denmark
Research centre Roskilde, 4503
Roskilde, Denmark
Research centre Aix en Provence, 3311
Aix-en-Provence, France
Research centre Caen, 3308
Caen, France
Research centre Caen, 3309
Caen, France
Research centre Clermont-Ferrand, 3303
Clermont-Ferrand, France
Research centre Dijon, 3313
Dijon, France
Research centre Grenoble, 3312
Grenoble, France
Research centre Lyon, 3316
Lyon, France
Research centre Nancy, 3314
Nancy, France
Research centre Paris, 3301
Paris, France
Research centre Paris, 3305
Paris, France
Research centre Rouen, 3307
Rouen, France
Research centre Saint Etienne, 3310
Saint-Etienne, France
Research centre Toulouse, 3302
Toulouse, France
Research centre Bad Krozingen, 4904
Bad Krozingen, Germany
Research centre Bad Nauheim, 4902
Bad Nauheim, Germany
Research centre Berlin, 4918
Berlin, Germany
Research centre Bonn, 4911
Bonn, Germany
Research centre Dresden, 4908
Dresden, Germany
Research centre Essen, 4903
Essen, Germany
Research centre Fulda, 4905
Fulda, Germany
Research centre Giessen 4901
Giessen, Germany
Research centre Göttingen, 4907
Göttingen, Germany
Research centre Landshut, 4909
Landshut, Germany
Research centre Lubeck, 4917
LĂ¼beck, Germany
Research centre Mainz, 4910
Mainz, Germany
Research centre Mannheim, 4912
Mannheim, Germany
Research centre Mönchengladbach, 4915
Mönchengladbach, Germany
Research centre Neuss, 4916
Neuss, Germany
Research centre Tubingen, 4914
TĂ¼bingen, Germany
Research centre Villingen - Schwenningen, 4919
Villingen-Schwenningen, Germany
Research centre BalatonfĂ¼red, 3608
BalatonfĂ¼red, Hungary
Research centre Budapest, 3602
Budapest, Hungary
Research centre Budapest, 3603
Budapest, Hungary
Research centre Debrecen, 3607
Debrecen, Hungary
Research centre Gyula, 3606
Gyula, Hungary
Research centre NyĂregyhĂ¡za, 3605
NyĂregyhĂ¡za, Hungary
Research centre PĂ©cs, 3604
PĂ©cs, Hungary
Research centre szeged, 3601
Szeged, Hungary
Research centre Arezzo, 3902
Arezzo, Italy
Research centre Brescia, 3912
Brescia, Italy
Research centre Ferrara, 3905
Ferrara, Italy
Research centre Milano, 3901
Milan, Italy
Research centre Pavia, 3903
Pavia, Italy
Research centre Terni, 3909
Terni, Italy
Research centre Alkmaar, 3106
Alkmaar, Netherlands
OLVG Research centre Amsterdam, 3104
Amsterdam, Netherlands
UMCG Groningen, 3108
Groningen, Netherlands
Research centre Leeuwarden, 3102
Leeuwarden, Netherlands
Research centre Nieuwegein, 3107
Nieuwegein, Netherlands
Research centre Nijmegen, 3105
Nijmegen, Netherlands
EMC Rotterdam, 3101
Rotterdam, Netherlands
Maasstad Rotterdam, 3103
Rotterdam, Netherlands
Research centre Tilburg, 3109
Tilburg, Netherlands
Research centre Chrzanow, 4802
ChrzanĂ³w, Poland
Research centre Dabrowa Gornicza, 4801
DÄ…browa GĂ³rnicza, Poland
Research centre Kedzierzyn-Kozle, 4805
Kędzierzyn-Koźle, Poland
Research centre Krakov, 4807
Krakow, Poland
Research centre Mielec, 4809
Mielec, Poland
Research centre Nysa, 4808
Nysa, Poland
Research centre Ustroń, 4803
Ustroń, Poland
Research centre Gaia, 3501
Gaia, Portugal
Research centre Lisbon, 3503
Lisbon, Portugal
Research centre Lisbon, 3504
Lisbon, Portugal
Research centre Lisbon, 3505
Lisbon, Portugal
Research centre Singapore, 6501
Singapore, Singapore
Research centre Singapore, 6502
Singapore, Singapore
Research centre Barcelona, 3401
Barcelona, Spain
Research centre Barcelona, 3403
Barcelona, Spain
Research centre Barcelona, 3405
Barcelona, Spain
Research centre Huelva, 3408
Huelva, Spain
Research centre Madrid 3410
Madrid, Spain
Research centre Madrid, 3402
Madrid, Spain
Research centre Madrid, 3407
Madrid, Spain
Research centre Madrid, 3409
Madrid, Spain
Research centre Vigo, 3404
Vigo, Spain
Research centre Bern, 4106
Bern, Switzerland
Research centre Bern, 4107
Bern, Switzerland
Research centre Geneva, 4101
Geneva, Switzerland
Research centre Lausanne, 4104
Lausanne, Switzerland
Research centre Liestal, 4108
Liestal, Switzerland
Research centre Lugano, 4105
Lugano, Switzerland
Research centre Belfast, 4420
Belfast, United Kingdom
Research Centre Belfast, 4423
Belfast, United Kingdom
Research centre Blackburn, 4404
Blackburn, United Kingdom
Research centre Blackpool, 4408
Blackpool, United Kingdom
Research centre Bournemouth, 4418
Bournemouth, United Kingdom
Research centre Brighton, 4405
Brighton, United Kingdom
Research centre Cambridge, 4417
Cambridge, United Kingdom
Research centre Cardiff, 4402
Cardiff, United Kingdom
Research centre Glasgow, 4407
Glasgow, United Kingdom
Research centre Leicester, 4421
Leicester, United Kingdom
Research centre Liverpool, 4001
Liverpool, United Kingdom
Research centre Manchester, 4403
Manchester, United Kingdom
Research centre Manchester, 4406
Manchester, United Kingdom
Research centre Newcastle, 4413
Newcastle, United Kingdom
Research centre Rhyl, 4414
Rhyl, United Kingdom
Research centre Southampton, 4415
Southampton, United Kingdom
Research centre Stevenage, 4412
Stevenage, United Kingdom
Research centre Wolverhampton, 4422
Wolverhampton, United Kingdom
Related Publications (20)
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.
PMID: 30166073BACKGROUNDWoelders ECI, Onuma Y, Ninomiya K, O'Leary N, Damman P, Peeters DAM, Hof AWJV', Valgimigli M, Vranckx P, Windecker S, Serruys PWJC, van Geuns RM. Parsimonious versus extensive bleeding score: can we simplify risk stratification after percutaneous coronary intervention and reduce bleeding events by de-escalation of the antiplatelet strategy? Open Heart. 2025 Jan 28;12(1):e003083. doi: 10.1136/openhrt-2024-003083.
PMID: 39875171DERIVEDOno 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.
PMID: 35260381DERIVEDGragnano 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.
PMID: 35229616DERIVEDWestra 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.
PMID: 35041147DERIVEDVranckx 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.
PMID: 34533034DERIVEDGao 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.
PMID: 33066794DERIVEDKawashima 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.
PMID: 33065080DERIVEDGao 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.
PMID: 32941872DERIVEDHara 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.
PMID: 32838554DERIVEDHara 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.
PMID: 32762446DERIVEDOno 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.
PMID: 32006156DERIVEDTomaniak 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.
PMID: 31925529DERIVEDTomaniak 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.
PMID: 31876907DERIVEDTomaniak 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.
PMID: 31845894DERIVEDChichareon 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.
PMID: 31693078DERIVEDTakahashi 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.
PMID: 31623758DERIVEDTomaniak 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.
PMID: 31557763DERIVEDSerruys 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.
PMID: 30888959DERIVEDLeonardi 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.
PMID: 30852547DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Pascal Vranckx
- Organization
- Jessa Ziekenhuis, Hasselt, Belgium
Study Officials
- STUDY DIRECTOR
Ernest Spitzer, MD
European Cardiovascular Research Institute
- PRINCIPAL INVESTIGATOR
Stephan Windecker, Prof. MD
Inselspital, University Hospital Bern, Switzerland
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2013
First Posted
March 19, 2013
Study Start
July 1, 2013
Primary Completion
November 9, 2015
Study Completion
April 26, 2018
Last Updated
March 15, 2022
Results First Posted
July 5, 2019
Record last verified: 2022-03