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

• Status: Completed
• Trial end date: 2018-04-26
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ECRI bv
• Collaborators: AstraZeneca; Biosensors International; The Medicines Company
• Treatments: Aspirin; Clopidogrel; Ticagrelor

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.