Coronary Artery DiseasePhase 4STEEL-PCINCT02327624
STEEL Percutaneous Coronary Intervention
A Phase 4 study testing Clopidogrel, Ticagrelor 60 and Ticagrelor 90 in people with Coronary Artery Disease, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Clopidogrel, Ticagrelor 60 and Ticagrelor 90
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to 31 May 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Male or female aged greater than 18 years
- Previous invasive coronary angiography with plan for PCI with coronary stent implantation for stable coronary artery disease
Who cannot join
- Requirement for a chronic total occlusion to be crossed in order for any stent implantation to proceed
- Plan for coronary angiography with a view to PCI if appropriate (i.e. current coronary anatomy not known)
- Intention to use platelet function tests or genotyping to guide antiplatelet therapy
- Known allergy to or intolerance of aspirin, clopidogrel or ticagrelor
- 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
- Planned treatment or consideration of treatment with oral antiplatelet medication other than aspirin or clopidogrel following PCI
Show all 21Show fewer
- Planned use of a glycoprotein IIb/IIIa antagonist for the PCI procedure
- Myocardial infarction within the past 12 months
- Current or planned use of an oral anticoagulant (e.g. warfarin, dabigatran, rivaroxaban, apixaban)
- Previous history of intracranial haemorrhage or other intracranial pathology associated with increased bleeding risk
- Haemoglobin < 100 g/L or other evidence of active bleeding
- Peptic ulceration documented by endoscopy within the last 3 months unless healing proven by repeat endoscopy
- History of acute or chronic liver disease (e.g. cirrhosis)
- Treatment in the last 10 days or requirement for ongoing treatment with a strong CYP3A4 inhibitor or inducer (see section 5.6.8)
- Requirement for ongoing treatment with simvastatin or lovastatin at a dose greater than 40 mg per day
- Treatment with a CYP3A4 substrate with a narrow therapeutic index (e.g. cyclosporine, quinidine)
- End-stage renal failure requiring dialysis
- History of alcohol or drug abuse in the last year
- Co-morbidity associated with life expectancy less than 1 year
- 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
- Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with ticagrelor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Two Regimens of TicagrElor Compared to Clopidogrel in Patients Undergoing ELective Percutaneous Coronary Intervention
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).
Read the detailed description
Coronary artery disease (CAD) is caused by fatty deposits building up over time in the arteries that supply the heart with blood, causing the arteries to narrow and reducing the amount of blood that can get to the heart. One of the treatment options for CAD is percutaneous coronary intervention (PCI) in which a balloon is inserted into the artery supplying the heart to open up the artery where it has narrowed. A stent is then left in the artery once the balloon is removed to hold the artery open and allow more blood to flow to the heart. One of the risks of this procedure, as in CAD itself, is the formation of blood clots that then block the arteries, stopping or reducing blood flow and causing a heart attack.
Platelets are small blood cells involved in the formation of 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 in the future and causing a heart attack. In a recent large clinical trial (PLATO study), it was shown that heart attack patients treated with a new antiplatelet medication (ticagrelor) had fewer later heart attacks compared to the current standard treatment (clopidogrel). The STEELPCI study is comparing three different strategies for prescribing antiplatelet medication to patients with stable CAD who have a PCI.
Patients on waiting list for PCI who meet the study inclusion/exclusion criteria will be invited to participate. Patients will have their PCI as normal but be randomised to take one of three different medication strategies, either clopidogrel or one of two doses of ticagrelor. Patient will 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Clopidogrel, Ticagrelor 60, Ticagrelor 90
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Compare Clopidogrel to two doses of Ticagrelor 60 and 90
Ticagrelor 60Drug
Compare Clopidogrel to two doses of Ticagrelor 60 and 90
Ticagrelor 90Drug
Compare Clopidogrel to two doses of Ticagrelor 60 and 90
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Active comparator | The standard antiplatelet treatment for patients is pretreatment with aspirin and clopidogrel. In this trial patients will be randomised in clopidogrel orTicagrelor of two doses Receives: Drug: Clopidogrel |
| Ticagrelor 60 | Experimental | Ticagrelor 60 is a new dosage to be tried in this trial. Receives: Drug: Ticagrelor 60 |
| Ticagrelor 90 | Experimental | Ticagrelor 90 is used following clopidogrel as maintenance therapy with aspirin 75 mg daily and clopidogrel 75 mg daily following PCI for at least 1 month. Receives: Drug: Ticagrelor 90 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet function in the three treatment groups
Measured: 2 years
Secondary outcomes (2)
Rates of myocardial infarction following PCI
Measured: 2 years
Plasma adenosine concentration in the three treatment groups
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startJun 2015
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327624
- Sponsor's protocol ID
- STH18423
- Acronym
- STEEL-PCI
- Status last verified
- Jan 2019
- First submitted
- 10 Dec 2014
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Orme RC, Parker WAE, Thomas MR, Judge HM, Baster K, Sumaya W, Morgan KP, McMellon HC, Richardson JD, Grech ED, Wheeldon NM, Hall IR, Iqbal J, Barmby D, Gunn JP, Storey RF. Study of Two Dose Regimens of Ticagrelor Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention for Stable Coronary Artery Disease. Circulation. 2018 Sep 25;138(13):1290-1300. doi: 10.1161/CIRCULATIONAHA.118.034790. Epub 2018 Jul 24.
PubMed 29930021
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Two Regimens of TicagrElor Compared to Clopidogrel in Patients Undergoing ELective Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT02327624
- Acronym / sponsor ID
- STEEL-PCI / STH18423
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jun 2015 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Coronary artery disease (CAD) is caused by fatty deposits building up over time in the arteries that supply the heart with blood, causing the arteries to narrow and reducing the amount of blood that can get to the heart. One of the treatment options for CAD is percutaneous coronary intervention (PCI) in which a balloon is inserted into the artery supplying the heart to open up the artery where it has narrowed. A stent is then left in the artery once the balloon is removed to hold the artery open and allow more blood to flow to the heart. One of the risks of this procedure, as in CAD itself, is the formation of blood clots that then block the arteries, stopping or reducing blood flow and causing a heart attack.
Platelets are small blood cells involved in the formation of 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 in the future and causing a heart attack. In a recent large clinical trial (PLATO study), it was shown that heart attack patients treated with a new antiplatelet medication (ticagrelor) had fewer later heart attacks compared to the current standard treatment (clopidogrel). The STEELPCI study is comparing three different strategies for prescribing antiplatelet medication to patients with stable CAD who have a PCI.
Patients on waiting list for PCI who meet the study inclusion/exclusion criteria will be invited to participate. Patients will have their PCI as normal but be randomised to take one of three different medication strategies, either clopidogrel or one of two doses of ticagrelor. Patient will 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | Active comparator | Drug: ClopidogrelThe standard antiplatelet treatment for patients is pretreatment with aspirin and clopidogrel. In this trial patients will be randomised in clopidogrel orTicagrelor of two doses |
| Ticagrelor 60 | Experimental | Drug: Ticagrelor 60Ticagrelor 60 is a new dosage to be tried in this trial. |
| Ticagrelor 90 | Experimental | Drug: Ticagrelor 90Ticagrelor 90 is used following clopidogrel as maintenance therapy with aspirin 75 mg daily and clopidogrel 75 mg daily following PCI for at least 1 month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of informed consent prior to any study specific procedures
- Male or female aged greater than 18 years
- Previous invasive coronary angiography with plan for PCI with coronary stent implantation for stable coronary artery disease
Key exclusion criteria (21 listed)
- Requirement for a chronic total occlusion to be crossed in order for any stent implantation to proceed
- Plan for coronary angiography with a view to PCI if appropriate (i.e. current coronary anatomy not known)
- Intention to use platelet function tests or genotyping to guide antiplatelet therapy
- Known allergy to or intolerance of aspirin, clopidogrel or ticagrelor
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClopidogrelCompare Clopidogrel to two doses of Ticagrelor 60 and 90 | Drug | Clopidogrel |
| Ticagrelor 60Compare Clopidogrel to two doses of Ticagrelor 60 and 90 | Drug | Ticagrelor 60 |
| Ticagrelor 90Compare Clopidogrel to two doses of Ticagrelor 60 and 90 | Drug | Ticagrelor 90 |
Primary outcome
Platelet function in the three treatment groups
Time frame: 2 years
2 secondary outcomes
Rates of myocardial infarction following PCI
Time frame: 2 years
Plasma adenosine concentration in the three treatment groups
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Derived from this study: PubMed 29930021Orme RC, Parker WAE, Thomas MR, Judge HM, Baster K, Sumaya W, Morgan KP, McMellon HC, Richardson JD, Grech ED, Wheeldon NM, Hall IR, Iqbal J, Barmby D, Gunn JP, Storey RF. Study of Two Dose Regimens of Ticagrelor Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention for Stable Coronary Artery Disease. Circulation. 2018 Sep 25;138(13):1290-1300. doi: 10.1161/CIRCULATIONAHA.118.034790. Epub 2018 Jul 24.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel, Ticagrelor 60 and Ticagrelor 90 in people with Coronary Artery Disease, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet function in the three treatment groups (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02327624, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.