Status:
COMPLETED
GLOBAL LEADERS Adjudication Sub-Study
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
European Cardiovascular Research Center
Conditions:
Coronary Artery Disease
Platelet-aggregation Inhibitors
Eligibility:
All Genders
18+ years
Brief Summary
The GLOBAL LEADERS Adjudication Sub-StudY, GLASSY, is based on a re-assessment of all the events reported in the dataset of the parent trial (COMPARATIVE EFFECTIVENESS OF 1 MONTH OF TICAGRELOR PLUS AS...
Detailed Description
The GLOBAL LEADERS trial was designed to determine the benefits and risks of an antithrombotic regimen using ticagrelor 90 mg BID combined with low-dose (75 mg OD) acetylsalicylic acid (ASA) for one m...
Eligibility Criteria
Inclusion
- "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
- 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 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
Key Trial Info
Start Date :
June 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2020
Estimated Enrollment :
7365 Patients enrolled
Trial Details
Trial ID
NCT03231059
Start Date
June 1 2017
End Date
May 30 2020
Last Update
August 3 2020
Active Locations (19)
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1
Wilhelminenspital 1160
Vienna, Austria
2
Research centre Bonheiden 3204
Bonheiden, Belgium
3
Research centre Charleroi 3202
Charleroi, Belgium
4
Research centre Genk 3205
Genk, Belgium