GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation
Condition: Coronary Artery Disease (CAD)
MeSH terms: Coronary Artery Disease
Intervention: Ticagrelor; Acetylsalicylic Acid; Clopidogrel
Intervention description: 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.; 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; 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
Intervention MeSH terms: Aspirin; Clopidogrel; Ticagrelor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15991.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CAD; ACS; All comers; DAPT; PCI

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

          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.