Two different drug regimens in patients undergoing elective percutaneous coronary intervention

• Register: ISRCTN
• Last refreshed on: 31 August 2020
• Main ID: ISRCTN12219184
• Date of registration: 21/05/2015
• Prospective Registration: Yes
• Primary sponsor: Sheffield Teaching Hospitals NHS Trust
• Public title: Two different drug regimens in patients undergoing elective percutaneous coronary intervention
• Scientific title: Study of two regimens of TicagrElor compared to clopidogrel in patients undergoing ELective Percutaneous Coronary Intervention (STEEL PCI)
• Date of first enrolment: 08/06/2015
• Target sample size: 180
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN12219184
• Study type: Interventional
• Study design: Randomised interventional treatment study (Treatment)
• Phase: Not Specified

Countries of recruitment

United Kingdom

Contacts

• Name: Claire Bridge

Key inclusion & exclusion criteria

Inclusion criteria:
1. Provision of informed consent prior to any study specific procedures
2. Male or female >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
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. Endstage renal failure requiring dialysis
18. History of alcohol or drug abuse in the last year
19. Comorbidity associated with life expectancy <1 year
20. Females of childbearing 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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Atherothrombosis
Circulatory System
Atherosclerotic cardiovascular disease

Intervention(s)

Patients will have their PCI as normal but are randomised to take one of three different medication strategies for 30 days:
1. Clopidogrel
2. Dose 1 ticagrelor
3. Dose 2 ticagrelor

Primary Outcome(s)

Adenosine reuptake measured by blood test.

Secondary Outcome(s)

Not available at time of registration.

Secondary ID(s)

NCT02327624

2014-004783-38

18975

Source(s) of Monetary Support

AstraZeneca UK Limited (UK)

Ethics review

Status:
Approval date:
Contact:

Ref:14/YH/1274

Results

• Results available: Yes
• Date Completed: 08/12/2016