Two different drug regimens in patients undergoing elective percutaneous coronary intervention
| ISRCTN | ISRCTN12219184 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12219184 |
| EudraCT/CTIS number | 2014-004783-38 |
| ClinicalTrials.gov number | NCT02327624 |
| Secondary identifying numbers | 18975 |
- Submission date
- 20/05/2015
- Registration date
- 21/05/2015
- Last edited
- 17/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Coronary artery disease (CAD) is caused by fatty deposits building up over time in the arteries that supply the heart with blood. The fatty deposits cause the arteries to narrow, eventually reducing the amount of blood that can get to the heart. One of the treatment options for CAD is percutaneous coronary intervention (PCI). In PCI, a balloon is inserted into the artery supplying blood to the heart to open it up where it has narrowed. A small mesh tube called a stent is then left in the artery once the balloon is removed to permanently hold the artery open and allow more blood to flow to the heart. One of the risks of PCI stent insertion, and also in CAD, is the formation of blood clots that can block the arteries, stopping or reducing blood flow and causing a heart attack. Small blood cells called platelets are involved in the formation of the blood clots that cause heart attacks. Antiplatelet drugs (e.g. aspirin) are given to patients with CAD to reduce the risk of a clot forming and causing a heart attack. In a recent large clinical trial (the PLATO study), it was shown that heart attack patients treated with the new antiplatelet drug ticagrelor had fewer heart attacks compared to the current standard drug treatment clopidogrel. The aim of this study is to compare three different treatment strategies for prescribing these antiplatelet drugs to patients with stable CAD following PCI stent surgery.
Who can participate?
Adults with stable CAD on a waiting list for PCI stent implantation.
What does the study involve?
All participants have standard PCI stent surgery. Participants are then randomly allocated into one of three groups. Those in group 1 (intervention group) are given the drug clopidogrel. Those in group 2 (intervention group) are given dose 1 of the drug ticagrelor. Those in group 3 (intervention group) are given dose 2 of the drug ticagrelor. Participants take the medication for 30 days and have blood tests and meet with the research team during that time to assess the effects of each medication strategy.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
University of Sheffield (UK)
When is the study starting and how long is it expected to run for?
June 2015 to December 2016
Who is funding the study?
AstraZeneca UK Limited (UK)
Who is the main contact?
Mrs C Bridge
Contact information
Scientific
University of Sheffield
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
Study information
| Study design | Randomised interventional treatment study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Study of two regimens of TicagrElor compared to clopidogrel in patients undergoing ELective Percutaneous Coronary Intervention (STEEL PCI) |
| Study acronym | STEEL PCI |
| Study objectives | Not available at time of registration. |
| Ethics approval(s) | Ref:14/YH/1274 |
| Health condition(s) or problem(s) studied | Atherothrombosis |
| Intervention | 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 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 1. Ticagrelor 2. Clopidogrel |
| Primary outcome measure | Adenosine reuptake measured by blood test. |
| Secondary outcome measures | Not available at time of registration. |
| Overall study start date | 08/06/2015 |
| Completion date | 08/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 180 |
| Total final enrolment | 180 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 08/06/2015 |
| Date of final enrolment | 08/12/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Herries Road
Sheffield
S5 7AU
United Kingdom
Sponsor information
Hospital/treatment centre
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
England
United Kingdom
"ROR" |
https://ror.org/018hjpz25 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/06/2018 | 17/08/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
17/08/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NCT code has been added.
