GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation

Conditions

Coronary Artery Disease (CAD)

Keywords

CAD, ACS, All comers, DAPT, PCI

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.

E C I Woelders, Yoshinobu Onuma, Kai Ninomiya, Neil O’Leary, Peter Damman et al. (12 authors)

Open Heart2025-01-01

10.1136/openhrt-2024-003083

Ticagrelor monotherapy versus aspirin monotherapy at 12 months after percutaneous coronary intervention: a landmark analysis of the GLOBAL LEADERS trial.

Masafumi Ono, Rutao Wang, Hideyuki Kawashima, Chao Gao, Rutao Wang et al. (15 authors)

PubMed2022-08-0511 citations

10.4244/eij-d-21-00870

Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug‐Eluting Stent Implantation: Per‐Protocol Analysis of the GLOBAL LEADERS Trial

Felice Gragnano, Marcel Zwahlen, Pascal Vranckx, Dik Heg, Kurt Schmidlin et al. (100 authors)

Journal of the American Heart Association2022-03-0110 citations

10.1161/jaha.121.024291

Characterization of quantitative flow ratio and fractional flow reserve discordance using doppler flow and clinical follow-up.

Westra J, Eftekhari A, Renkens M, Mejía-Rentería H, Sejr-Hansen M, Stegehuis V, Holm NR, de Winter RJ, Piek JJ, Escaned J, Wykrzykowska JJ, Christiansen EH.

2022-01-182 citations

10.1007/s10554-022-02522-1

Efficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre‐Specified Analysis of the GLOBAL LEADERS Trial

Pascal Vranckx, Marco Valgimigli, Ayodele Odutayo, Patrick W. Serruys, Christian W. Hamm et al. (18 authors)

Journal of the American Heart Association2021-09-1748 citations

10.1161/jaha.119.015560

Ticagrelor monotherapy beyond 1 month versus standard dual antiplatelet therapy after drug-eluting coronary stenting: a pre-specified per-protocol analysis of the GLOBAL LEADERS trial

Felice Gragnano, Marcel Zwahlen, P Vranckx, Peter Jüni, Dik Heg et al. (15 authors)

European Heart Journal2020-11-01

10.1093/ehjci/ehaa946.2577

Ticagrelor monotherapy in patients with concomitant diabetes mellitus and chronic kidney disease: a post hoc analysis of the GLOBAL LEADERS trial.

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.

2020-10-1620 citations

10.1186/s12933-020-01153-x

Regional variation in patients and outcomes in the GLOBAL LEADERS trial.

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.

2020-09-153 citations

10.1016/j.ijcard.2020.09.039

Impact of Bleeding and Myocardial Infarction on Mortality in All-Comer Patients Undergoing Percutaneous Coronary Intervention

Hironori Hara, Kuniaki Takahashi, Norihiro Kogame, Mariusz Tomaniak, Laura S.M. Kerkmeijer et al. (23 authors)

Circulation Cardiovascular Interventions2020-08-2532 citations

10.1161/circinterventions.120.009177

Comparative Methodological Assessment of the Randomized GLOBAL LEADERS Trial Using Total Ischemic and Bleeding Events

Hironori Hara, David van Klaveren, Kuniaki Takahashi, Norihiro Kogame, Ply Chichareon et al. (28 authors)

Circulation Cardiovascular Quality and Outcomes2020-07-3017 citations

10.1161/circoutcomes.120.006660

Ticagrelor monotherapy beyond one month after PCI in ACS or stable CAD in elderly patients: a pre-specified analysis of the GLOBAL LEADERS trial

Mariusz Tomaniak, Ply Chichareon, Rodrigo Modolo, Kuniaki Takahashi, Chun Chin Chang et al. (28 authors)

EuroIntervention2020-04-0128 citations

10.4244/eij-d-19-00699

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.

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, Jüni P, Hamm C, Steg PG, Valgimigli M, Windecker S, Storey RF, Onuma Y, Vranckx P, Serruys PW.

2020-01-3116 citations

10.1007/s00392-020-01604-1

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.

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.

2020-01-1018 citations

10.1007/s00392-019-01586-9

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

Mariusz Tomaniak, Ply Chichareon, Kuniaki Takahashi, Norihiro Kogame, Rodrigo Modolo et al. (29 authors)

European Heart Journal - Cardiovascular Pharmacotherapy2019-12-0510 citations

10.1093/ehjcvp/pvz052

Patient-oriented composite endpoints and net adverse clinical events with ticagrelor monotherapy following percutaneous coronary intervention: insights from the randomised GLOBAL LEADERS trial

Patrick W. Serruys, Mariusz Tomaniak, Ply Chichareon, Rodrigo Modolo, Norihiro Kogame et al. (23 authors)

EuroIntervention2019-12-0120 citations

10.4244/eij-d-19-00202

Association of Sex With Outcomes in Patients Undergoing Percutaneous Coronary Intervention

Ply Chichareon, Rodrigo Modolo, Laura S.M. Kerkmeijer, Mariusz Tomaniak, Norihiro Kogame et al. (24 authors)

JAMA Cardiology2019-11-0678 citations

10.1001/jamacardio.2019.4296

Efficacy and Safety of Ticagrelor Monotherapy in Patients Undergoing Multivessel PCI.

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.

2019-10-0120 citations

10.1016/j.jacc.2019.08.997

Benefit and Risks of Aspirin in Addition to Ticagrelor in Acute Coronary Syndromes

Mariusz Tomaniak, Ply Chichareon, Yoshinobu Onuma, Efthymios Deliargyris, Kuniaki Takahashi et al. (20 authors)

JAMA Cardiology2019-09-26131 citations

10.1001/jamacardio.2019.3355

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)

Sergio Leonardi, Anna Franzone, Raffaele Piccolo, Eugène McFadden, Pascal Vranckx et al. (31 authors)

BMJ Open2019-03-0122 citations

10.1136/bmjopen-2018-026053

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.

Vranckx P, Valgimigli M, Jüni P, Hamm C, Steg PG, Heg D, van Es GA, McFadden EP, Onuma Y, van Meijeren C, Chichareon P, Benit E, Möllmann 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.

2018-08-27530 citations

10.1016/s0140-6736(18)31858-0

Platelet inhibition during ticagrelor monotherapy versus ticagrelor plus aspirin in patients with coronary artery disease (TEMPLATE study): study protocol for a randomised controlled trial

Sarah Baos, Wendy Underwood, Lucy Culliford, Barnaby C Reeves, Chris Rogers et al. (9 authors)

Trials2017-11-096 citations

10.1186/s13063-017-2277-9

Interventions

DRUGTicagrelor

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.

DRUGAcetylsalicylic Acid

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

DRUGClopidogrel

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI)	2 year	Number of Participants with a composite of all-cause mortality or non-fatal new Q-wave MI up to 2 years post randomisation.

Secondary

Measure	Time frame	Description
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	shown are the first event per event type for each patient only. Multiple events of the same type within the same patient are disregarded
Number of Participants With All-cause Mortality	2-year	—
Number of Participants With a Myocardial Revascularisation	2 year	—
Number of Participants With a Definite Stent Thrombosis	2 year	—
Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding	2 year	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: * Type 3a: * Overt bleeding + Hb drop of 3 to \< 5 g/dL (provided Hb drop is related to bleed) * Any transfusion with overt bleeding * Type 3b: * Overt bleeding + Hb drop ≥5 g/dL (provided Hb drop is related to bleed) * Cardiac tamponade * Bleeding requiring surgical intervention (excluding dental/nasal/skin/haemorrhoid) * Bleeding requiring intravenous vasoactive agents * Type 3c: * Intracranial haemorrhage (does not include microbleeds or haemorrhagic transformation, does include intraspinal) * Subcategories confirmed by autopsy or imaging or lumbar puncture * Intraocular bleed compromising vision. Type 5: Fatal bleeding * Type 5a: • Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious * Type 5b: * Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation
Number of Participants With a Stroke	2 year	—

Countries

Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Singapore, Spain, Switzerland, United Kingdom

Participant flow

Pre-assignment details

12 participants of the experimental group withdrew consent or objected to use further use of data 11 participants of the reference group withdrew consent or objected to use further use of data

Participants by arm

Arm	Count
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) Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy. Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy	7,980
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 Ticagrelor: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy. Acetylsalicylic Acid: Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy Clopidogrel: Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for	7,988
Total	15,968

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	did not finish experimental regimen	1,902	770
Overall Study	Lost to Follow-up	268	237

Baseline characteristics

Characteristic	Experimental Treatment Strategy	Reference Treatment Strategy	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	4031 Participants	4060 Participants	8091 Participants
Age, Categorical Between 18 and 65 years	3949 Participants	3928 Participants	7877 Participants
Age, Continuous	64.5 years STANDARD_DEVIATION 10.3	64.6 years STANDARD_DEVIATION 10.3	64.6 years STANDARD_DEVIATION 10.3
Region of Enrollment Australia	41 participants	42 participants	83 participants
Region of Enrollment Austria	335 participants	337 participants	672 participants
Region of Enrollment Belgium	1094 participants	1091 participants	2185 participants
Region of Enrollment Brazil	126 participants	122 participants	248 participants
Region of Enrollment Bulgaria	470 participants	473 participants	943 participants
Region of Enrollment Canada	84 participants	86 participants	170 participants
Region of Enrollment Denmark	66 participants	65 participants	131 participants
Region of Enrollment France	426 participants	423 participants	849 participants
Region of Enrollment Germany	1129 participants	1138 participants	2267 participants
Region of Enrollment Hungary	264 participants	263 participants	527 participants
Region of Enrollment Italy	790 participants	788 participants	1578 participants
Region of Enrollment Netherlands	579 participants	580 participants	1159 participants
Region of Enrollment Poland	768 participants	764 participants	1532 participants
Region of Enrollment Portugal	56 participants	57 participants	113 participants
Region of Enrollment Singapore	71 participants	71 participants	142 participants
Region of Enrollment Spain	475 participants	476 participants	951 participants
Region of Enrollment Switzerland	352 participants	353 participants	705 participants
Region of Enrollment United Kingdom	854 participants	859 participants	1713 participants
Sex: Female, Male Female	1865 Participants	1849 Participants	3714 Participants
Sex: Female, Male Male	6115 Participants	6139 Participants	12254 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	224 / 7,980	253 / 7,988
other Total, other adverse events	0 / 7,980	0 / 7,988
serious Total, serious adverse events	1,459 / 7,980	1,543 / 7,988

Outcome results

Primary

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.

Time frame: 2 year

Population: Shown are the first event per event type for each patient only. Multiple events of the same type within the same patient are disregarded. Data were censored 730 days after index percutaneous coronary intervention.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Experimental Treatment Strategy	Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI)	304 Participants
Reference Treatment Strategy	Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI)	349 Participants

Secondary

Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding

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: * Type 3a: * Overt bleeding + Hb drop of 3 to \< 5 g/dL (provided Hb drop is related to bleed) * Any transfusion with overt bleeding * Type 3b: * Overt bleeding + Hb drop ≥5 g/dL (provided Hb drop is related to bleed) * Cardiac tamponade * Bleeding requiring surgical intervention (excluding dental/nasal/skin/haemorrhoid) * Bleeding requiring intravenous vasoactive agents * Type 3c: * Intracranial haemorrhage (does not include microbleeds or haemorrhagic transformation, does include intraspinal) * Subcategories confirmed by autopsy or imaging or lumbar puncture * Intraocular bleed compromising vision. Type 5: Fatal bleeding * Type 5a: • Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious * Type 5b: * Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation

Time frame: 2 year

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Experimental Treatment Strategy	Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding	163 Participants
Reference Treatment Strategy	Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding	169 Participants

Secondary

Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction

shown are the first event per event type for each patient only. Multiple events of the same type within the same patient are disregarded

Time frame: 2-year

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Experimental Treatment Strategy	Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction	362 Participants
Reference Treatment Strategy	Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction	416 Participants

Secondary

Number of Participants With a Definite Stent Thrombosis

Time frame: 2 year

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Experimental Treatment Strategy	Number of Participants With a Definite Stent Thrombosis	64 Participants
Reference Treatment Strategy	Number of Participants With a Definite Stent Thrombosis	64 Participants

Secondary

Number of Participants With All-cause Mortality

Time frame: 2-year

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Experimental Treatment Strategy	Number of Participants With All-cause Mortality	224 Participants
Reference Treatment Strategy	Number of Participants With All-cause Mortality	253 Participants

Secondary

Number of Participants With a Myocardial Revascularisation

Time frame: 2 year

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Experimental Treatment Strategy	Number of Participants With a Myocardial Revascularisation	739 Participants
Reference Treatment Strategy	Number of Participants With a Myocardial Revascularisation	793 Participants

Secondary

Number of Participants With a Stroke

Time frame: 2 year

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Experimental Treatment Strategy	Number of Participants With a Stroke	80 Participants
Reference Treatment Strategy	Number of Participants With a Stroke	82 Participants

Secondary

Number of Participants With Myocardial Infarction

Time frame: 2 year

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Experimental Treatment Strategy	Number of Participants With Myocardial Infarction	248 Participants
Reference Treatment Strategy	Number of Participants With Myocardial Infarction	250 Participants

Secondary

Number of Participants With New Q-wave Myocardial Infarction

Time frame: 2-year

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Experimental Treatment Strategy	Number of Participants With New Q-wave Myocardial Infarction	83 Participants
Reference Treatment Strategy	Number of Participants With New Q-wave Myocardial Infarction	103 Participants

GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI)

Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding

Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction

Number of Participants With a Definite Stent Thrombosis

Number of Participants With All-cause Mortality

Number of Participants With a Myocardial Revascularisation

Number of Participants With a Stroke

Number of Participants With Myocardial Infarction

Number of Participants With New Q-wave Myocardial Infarction