Status:
COMPLETED
GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation
Lead Sponsor:
ECRI bv
Collaborating Sponsors:
Biosensors International
AstraZeneca
Conditions:
Coronary Artery Disease (CAD)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 medicatio...
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 b...
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 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2018
Estimated Enrollment :
15991 Patients enrolled
Trial Details
Trial ID
NCT01813435
Start Date
July 1 2013
End Date
April 26 2018
Last Update
March 15 2022
Active Locations (130)
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1
Research centre Brisbane, 6101
Brisbane, Australia
2
Research centre Melbourne, 6104
Melbourne, Australia
3
Research centre Melbourne, 6105
Melbourne, Australia
4
Research centre Graz, 4305
Graz, Austria