STEEL Percutaneous Coronary Intervention

• Status: Completed
• Trial end date: 2018-05-31
• Target enrollment: 0
• Participant gender: All

Summary

The principal hypothesis of this study is that two different maintenance regimens of ticagrelor are safe, tolerable and associated with significant inhibition of erythrocyte adenosine reuptake compared to clopidogrel in patients undergoing elective Percutaneous Coronary Intervention (PCI) for stable Coronary artery disease (CAD).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborator: AstraZeneca
• Treatments: Clopidogrel; Ticagrelor; Ticlopidine

Criteria

Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures

2. Male or female aged greater than 18 years

3. Previous invasive coronary angiography with plan for PCI with coronary stent implantation for stable coronary artery disease

Exclusion Criteria:

1. Requirement for a chronic total occlusion to be crossed in order for any stent implantation to proceed

2. Plan for coronary angiography with a view to PCI if appropriate (i.e. current coronary anatomy not known)

3. Intention to use platelet function tests or genotyping to guide antiplatelet therapy

4. Known allergy to or intolerance of aspirin, clopidogrel or ticagrelor

5. Treatment with antiplatelet medication apart from aspirin or clopidogrel that cannot be stopped 10 days prior to PCI (e.g. ticagrelor, prasugrel, dipyridamole, ticlopidine, abciximab, tirofiban), for example because of continuing indication

6. Planned treatment or consideration of treatment with oral antiplatelet medication other than aspirin or clopidogrel following PCI

7. Planned use of a glycoprotein IIb/IIIa antagonist for the PCI procedure

8. Myocardial infarction within the past 12 months

9. Current or planned use of an oral anticoagulant (e.g. warfarin, dabigatran, rivaroxaban, apixaban)

10. Previous history of intracranial haemorrhage or other intracranial pathology associated with increased bleeding risk

11. Haemoglobin < 100 g/L or other evidence of active bleeding

12. Peptic ulceration documented by endoscopy within the last 3 months unless healing proven by repeat endoscopy

13. History of acute or chronic liver disease (e.g. cirrhosis)

14. Treatment in the last 10 days or requirement for ongoing treatment with a strong CYP3A4 inhibitor or inducer (see section 5.6.8)

15. Requirement for ongoing treatment with simvastatin or lovastatin at a dose greater than 40 mg per day

16. Treatment with a CYP3A4 substrate with a narrow therapeutic index (e.g. cyclosporine, quinidine)

17. End-stage renal failure requiring dialysis

18. History of alcohol or drug abuse in the last year

19. Co-morbidity associated with life expectancy less than 1 year

20. Females of child-bearing potential unless negative pregnancy test at screening and willing to use effective contraception (i.e. established use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or barrier methods of contraception with spermicide or sole male partner with prior vasectomy and confirmed absence of sperm in ejaculate) for the duration of treatment with study medication

21. Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with ticagrelor