Phase 3
N=15,968
GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation
Coronary Artery Disease (CAD)
Bottom Line
View on ClinicalTrials.gov: NCT01813435 ↗Enrolled (actual)
15,968
Serious AEs
18.8%
Results posted
Jul 2019
Primary outcome: Primary: Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI) — 304; 349 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ticagrelor (Drug); Acetylsalicylic Acid (Drug); Clopidogrel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ECRI bv
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI) |
304; 349 | — |
| SECONDARY Number of Participants With All-cause Mortality |
224; 253 | — |
| SECONDARY Number of Participants With Myocardial Infarction |
248; 250 | — |
| SECONDARY Number of Participants With New Q-wave Myocardial Infarction |
83; 103 | — |
| SECONDARY Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction |
362; 416 | — |
| SECONDARY Number of Participants With a Stroke |
80; 82 | — |
| SECONDARY Number of Participants With a Myocardial Revascularisation |
739; 793 | — |
| SECONDARY Number of Participants With a Definite Stent Thrombosis |
64; 64 | — |
| SECONDARY Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding |
163; 169 | — |
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01813435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.