- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01813435
GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Brisbane, Australia
- Research centre Brisbane, 6101
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Melbourne, Australia
- Research centre Melbourne, 6104
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Melbourne, Australia
- Research centre Melbourne, 6105
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Graz, Austria
- Research centre Graz, 4305
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Innsbruck, Austria
- Rsearch centre Innsbruck, 4303
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Linz, Austria
- Research centre Linz, 4304
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Vienna, Austria
- Research centre Vienna, 4301
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Vienna, Austria
- Research centre Vienna, 4302
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Aalst, Belgium
- Research centre Aalst, 3201
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Aalst, Belgium
- Research centre Aalst, 3206
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Bonheiden, Belgium
- Research centre Bonheiden, 3204
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Charleroi, Belgium
- Research centre Charleroi, 3202
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Genk, Belgium
- Research centre Genk, 3205
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Hasselt, Belgium
- Research centre Hasselt, 3203
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Rio de Janeiro, Brazil
- Research centre Rio de Janeiro, 5503
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Rio de Janeiro, Brazil
- Research centre Rio de Janeiro, 5504
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Sao Paulo, Brazil
- Research centre Sao Paulo, 5501
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Sao Paulo, Brazil
- Research centre Sao Paulo, 5502
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Uberlândia, Brazil
- Research centre Uberlândia, 5505
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Burgas, Bulgaria
- Research centre Burgas, 9902
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Plovdiv, Bulgaria
- Research centre Plovdiv, 9905
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Sofia, Bulgaria
- Research centre Sofia, 9901
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Sofia, Bulgaria
- Research centre Sofia, 9903
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Sofia, Bulgaria
- Research centre Sofia, 9904
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Sofia, Bulgaria
- Research centre Sofia, 9907
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Sofia, Bulgaria
- Research centre Sofia, 9908
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Varna, Bulgaria
- Research centre Varna, 9906
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Newmarket, Canada
- Research centre Newmarket, 1003
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Quebec, Canada
- Research centre Quebec, 1001
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Copenhagen, Denmark
- Research centre Copenhagen, 4501
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Roskilde, Denmark
- Research centre Roskilde, 4503
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Aix en Provence, France
- Research centre Aix en Provence, 3311
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Caen, France
- Research centre Caen, 3308
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Caen, France
- Research centre Caen, 3309
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Clermont-Ferrand, France
- Research centre Clermont-Ferrand, 3303
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Dijon, France
- Research centre Dijon, 3313
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Grenoble Cedex, France
- Research centre Grenoble, 3312
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Lyon, France
- Research centre Lyon, 3316
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Nancy, France
- Research centre Nancy, 3314
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Paris, France
- Research centre Paris, 3301
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Paris, France
- Research centre Paris, 3305
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Rouen, France
- Research centre Rouen, 3307
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Saint Etienne, France
- Research centre Saint Etienne, 3310
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Toulouse, France
- Research centre Toulouse, 3302
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Bad Krozingen, Germany
- Research centre Bad Krozingen, 4904
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Bad Nauheim, Germany
- Research centre Bad Nauheim, 4902
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Berlin, Germany
- Research centre Berlin, 4918
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Bonn, Germany
- Research centre Bonn, 4911
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Dresden, Germany
- Research centre Dresden, 4908
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Essen, Germany
- Research centre Essen, 4903
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Fulda, Germany
- Research centre Fulda, 4905
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Giessen, Germany
- Research centre Giessen 4901
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Göttingen, Germany
- Research centre Göttingen, 4907
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Landshut, Germany
- Research centre Landshut, 4909
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Lubeck, Germany
- Research centre Lubeck, 4917
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Mainz, Germany
- Research centre Mainz, 4910
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Mannheim, Germany
- Research centre Mannheim, 4912
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Mönchengladbach, Germany
- Research centre Mönchengladbach, 4915
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Neuss, Germany
- Research centre Neuss, 4916
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Tubingen, Germany
- Research centre Tubingen, 4914
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Villingen - Schwenningen, Germany
- Research centre Villingen - Schwenningen, 4919
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Balatonfüred, Hungary
- Research centre Balatonfüred, 3608
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Budapest, Hungary
- Research centre Budapest, 3602
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Budapest, Hungary
- Research centre Budapest, 3603
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Debrecen, Hungary
- Research centre Debrecen, 3607
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Gyula, Hungary
- Research centre Gyula, 3606
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Nyíregyháza, Hungary
- Research centre Nyíregyháza, 3605
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Pécs, Hungary
- Research centre Pécs, 3604
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Szeged, Hungary
- Research centre szeged, 3601
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Arezzo, Italy
- Research centre Arezzo, 3902
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Brescia, Italy
- Research centre Brescia, 3912
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Ferrara, Italy
- Research centre Ferrara, 3905
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Milano, Italy
- Research centre Milano, 3901
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Pavia, Italy
- Research centre Pavia, 3903
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Terni, Italy
- Research centre Terni, 3909
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Alkmaar, Netherlands
- Research centre Alkmaar, 3106
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Amsterdam, Netherlands
- OLVG Research centre Amsterdam, 3104
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Groningen, Netherlands
- UMCG Groningen, 3108
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Leeuwarden, Netherlands
- Research centre Leeuwarden, 3102
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Nieuwegein, Netherlands
- Research centre Nieuwegein, 3107
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Nijmegen, Netherlands
- Research centre Nijmegen, 3105
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Rotterdam, Netherlands
- EMC Rotterdam, 3101
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Rotterdam, Netherlands
- Maasstad Rotterdam, 3103
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Tilburg, Netherlands
- Research centre Tilburg, 3109
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Chrzanow, Poland
- Research centre Chrzanow, 4802
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Dabrowa Gornicza, Poland
- Research centre Dabrowa Gornicza, 4801
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Kedzierzyn-Kozle, Poland
- Research centre Kedzierzyn-Kozle, 4805
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Krakov, Poland
- Research centre Krakov, 4807
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Mielec, Poland
- Research centre Mielec, 4809
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Nysa, Poland
- Research centre Nysa, 4808
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Ustroń, Poland
- Research centre Ustroń, 4803
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Gaia, Portugal
- Research centre Gaia, 3501
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Lisbon, Portugal
- Research centre Lisbon, 3503
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Lisbon, Portugal
- Research centre Lisbon, 3504
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Lisbon, Portugal
- Research centre Lisbon, 3505
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Singapore, Singapore
- Research centre Singapore, 6501
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Singapore, Singapore
- Research centre Singapore, 6502
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Barcelona, Spain
- Research centre Barcelona, 3401
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Barcelona, Spain
- Research centre Barcelona, 3403
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Barcelona, Spain
- Research centre Barcelona, 3405
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Huelva, Spain
- Research centre Huelva, 3408
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Madrid, Spain
- Research centre Madrid 3410
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Madrid, Spain
- Research centre Madrid, 3402
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Madrid, Spain
- Research centre Madrid, 3407
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Madrid, Spain
- Research centre Madrid, 3409
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Vigo, Spain
- Research centre Vigo, 3404
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Bern, Switzerland
- Research centre Bern, 4106
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Bern, Switzerland
- Research centre Bern, 4107
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Geneva, Switzerland
- Research centre Geneva, 4101
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Lausanne, Switzerland
- Research centre Lausanne, 4104
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Liestal, Switzerland
- Research centre Liestal, 4108
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Lugano, Switzerland
- Research centre Lugano, 4105
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Belfast, United Kingdom
- Research centre Belfast, 4420
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Belfast, United Kingdom
- Research Centre Belfast, 4423
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Blackburn, United Kingdom
- Research centre Blackburn, 4404
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Blackpool, United Kingdom
- Research centre Blackpool, 4408
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Bournemouth, United Kingdom
- Research centre Bournemouth, 4418
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Brighton, United Kingdom
- Research centre Brighton, 4405
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Cambridge, United Kingdom
- Research centre Cambridge, 4417
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Cardiff, United Kingdom
- Research centre Cardiff, 4402
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Glasgow, United Kingdom
- Research centre Glasgow, 4407
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Leicester, United Kingdom
- Research centre Leicester, 4421
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Liverpool, United Kingdom
- Research centre Liverpool, 4001
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Manchester, United Kingdom
- Research centre Manchester, 4403
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Manchester, United Kingdom
- Research centre Manchester, 4406
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Newcastle, United Kingdom
- Research centre Newcastle, 4413
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Rhyl, United Kingdom
- Research centre Rhyl, 4414
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Southampton, United Kingdom
- Research centre Southampton, 4415
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Stevenage, United Kingdom
- Research centre Stevenage, 4412
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Wolverhampton, United Kingdom
- Research centre Wolverhampton, 4422
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
-"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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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) |
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.
Other Names:
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
Other Names:
|
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 |
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.
Other Names:
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
Other Names:
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI)
Time Frame: 2 year
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Number of Participants with a composite of all-cause mortality or non-fatal new Q-wave MI up to 2 years post randomisation.
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2 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With All-cause Mortality
Time Frame: 2-year
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2-year
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Number of Participants With Myocardial Infarction
Time Frame: 2 year
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2 year
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Number of Participants With New Q-wave Myocardial Infarction
Time Frame: 2-year
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2-year
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Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction
Time Frame: 2-year
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shown are the first event per event type for each patient only.
Multiple events of the same type within the same patient are disregarded
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2-year
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Number of Participants With a Stroke
Time Frame: 2 year
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2 year
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Number of Participants With a Myocardial Revascularisation
Time Frame: 2 year
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2 year
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Number of Participants With a Definite Stent Thrombosis
Time Frame: 2 year
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2 year
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Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding
Time Frame: 2 year
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BARC definition. We only considered BARC 3 or 5 for this secondary safety endpoint. Type 3: Clinical, laboratory, and/or imaging evidence of bleeding with:
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2 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephan Windecker, Prof. MD, Inselspital, University Hospital Bern, Switzerland
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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 Jan 18. doi: 10.1007/s10554-022-02522-1. Online ahead of print.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Aspirin
- Ticagrelor
- Clopidogrel
Other Study ID Numbers
- ECRI-12-001, 02EU11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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