Is there a rebound increase in platelet aggregation following withdrawal of aspirin or ticagrelor in patients who have recently undergone PCI?

Not Applicable

Completed

• Conditions: Effects of dual anti-platelet therapy on platelet aggregation in patients who have received percutaneous coronary intervention (PCI) with coronary stenting.; Circulatory System

• Registration Number: ISRCTN69497594
• Lead Sponsor: HS National Waiting Times Centre Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-18
• Study Completion: 2015-05-19
• Last Update Posted: 17 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients eligible for this study are those already enrolled in the GLOBAL LEADERS study under the care of the Golden Jubilee National Hospital (UK) during the allocated study period.
2. The inclusion criteria for the GLOBAL LEADERS trial will apply to this study including:
2.1. Age =18 years
2.2. 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
2.3. Able to provide informed consent

Exclusion Criteria

The exclusion criteria for the GLOBAL LEADERS study will also apply to this study including:
1. Known intolerance to aspirin, P2Y12 inhibitors, bivalirudin, stainless steel or biolimus
2. 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. Moderate to severe hepatic impairment (alanine-aminotransferase = 3 x ULN)
4. 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
5. Need for chronic oral anti-coagulation therapy
6. Active major bleeding or major surgery within the last 30 days
7. History of intracranial haemorrhagic stroke or intra-cranial aneurysm
8. Stroke (any type) within the last 30 days
9. Pregnancy at time of randomisation
10. Breastfeeding at time of randomisation
11. Currently participating in another trial and not yet at its primary endpoint

Study & Design

• Study Type: Observational
• Study Design: Not specified