Acute Coronary SyndromePhase 4ALL COMERSNCT02957162
The Effect on EPCs by Statin Loading in "All Comers" With an ACS
A Phase 4 study testing Atorvastatin and Blood samples in people with Acute Coronary Syndrome, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
Trial summary
Cardiovascular disease is a major cause of morbidity and mortality worldwide. There are a number of risk factors for coronary artery disease and all to often patients admitted with an acute coronary syndrome have these comorbidities. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Atorvastatin and Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to 25 Sep 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted with an acute coronary syndrome
- Are statin naive or receiving a statin other than atorvastatin, or atorvastatin at a dose less than 80mg daily
- Are able to give informed consent
- Have undergone coronary angiography/plasty
- Are able to attend follow up visits
Who cannot join
- Atorvastatin is contraindicated (e.g. allergic to excipient)
- Women of child bearing potential unless they are using a recognised effective form of contraception or are not sexually active and have no intention of becoming sexually active during the course of the trial
- Women who are breastfeeding
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, ST4 6QG
About this study
Official title: The Effect on Endothelial Progenitor Cells (EPCs) by Statin Loading in "All Comers" With an Acute Coronary Syndrome (ACS)
Cardiovascular disease is a major cause of morbidity and mortality worldwide. There are a number of risk factors for coronary artery disease and all to often patients admitted with an acute coronary syndrome have these comorbidities.
The main stay of treatment of such patients is to perform coronary angiography and if required coronary angioplasty.
Previous studies have shown a link between endothelial progenitor cell (EPC) count, coronary artery disease and statin therapy or loading, however these studies have excluded patients with significant comorbidities and therefore have not truly represented "real life" patients. This pilot study will assess EPC response in patients that are able to undergo coronary intervention as part of their normal clinical management under current guidelines regardless of pre-existing comorbidities. The research team believe this will allow representation of "real world" patients.
Read the detailed description
This pilot study will include up to 40 patient-participants admitted into the coronary care unit of the Royal Stoke University Hospital a large and busy tertiary cardiac centre. Patient-participants will be assessed, and if deemed appropriate to undergo coronary angiography and or angioplasty will be eligible for enrolment in the study.
Following standard care angiogram / angioplasty, patient-participants will be given a minimum of 3 hours to consent to ensure that there is no delay in clinical treatment. A short information sheet will be given to the patient initially. If the patient is interested in the study, the full participant information sheet will be given. If potential patient-participants consent to study participation 3-5ml of blood will be venesected and sent for EPC analysis. That late evening atorvastatin 80mg will be given as per current national recommendations. Patient-participants will then have venesection for EPC analysis on days 1-2, 3-4 and finally 7-8. ACS patients are usually in hospital for 3 or 4 days provided there are no complications. It is therefore anticipated that days 0, 1-2 and 3-4 venesections may be performed whilst patient-participants are within the cardiology department. However an outpatient cardiology research clinic follow up will be arranged for day 7-8 to allow the final venesection for EPC analysis.
This pilot study will assess EPC response in patients that are able to undergo coronary intervention as part of their normal clinical management under current guidelines regardless of pre-existing comorbidities. The research team believe this will allow representation of "real world" patients.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Atorvastatin, Blood samples
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Blood samplesOther
3-5 mls of blood is taken at baseline and 3 subsequent timepoints and processed for Endothelial Progenitor Count (EPC).
| Study group | Role | What they receive |
|---|---|---|
| Blood samples and Atorvastatin 80mg | Other | All participants are given Atorvastatin 80mg as part of their standard care. The main study intervention is blood samples at days 1-2, 3-4 and 7-8. Receives: Drug: Atorvastatin; Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of EPCs (per microliter of blood) in patient-participants admitted with an ACS loaded with atorvastatin 80 mg
Measured: 8 days
Number of EPCs (per microliter of blood) in patient-participants with different comorbid conditions
Measured: 8 days
Number of EPCs (per microliter of blood) in participants who have been loaded or reloaded with atorvastatin
Measured: 8 days
The time of onset of pain to loading/reloading strategies.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2017
- Study completion25 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of North Midlands NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Butler, Principal investigator, University Hospitals of North Midlands NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957162
- Sponsor's protocol ID
- 995
- Acronym
- ALL COMERS
- Status last verified
- Apr 2019
- First submitted
- 19 Oct 2016
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on Endothelial Progenitor Cells (EPCs) by Statin Loading in "All Comers" With an Acute Coronary Syndrome (ACS)
- ClinicalTrials.gov ID
- NCT02957162
- Acronym / sponsor ID
- ALL COMERS / 995
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospitals of North Midlands NHS TrustUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- 25 Sep 2017 (actual)
- First posted
- 7 Nov 2016 (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.
Cardiovascular disease is a major cause of morbidity and mortality worldwide. There are a number of risk factors for coronary artery disease and all to often patients admitted with an acute coronary syndrome have these comorbidities.
The main stay of treatment of such patients is to perform coronary angiography and if required coronary angioplasty.
Previous studies have shown a link between endothelial progenitor cell (EPC) count, coronary artery disease and statin therapy or loading, however these studies have excluded patients with significant comorbidities and therefore have not truly represented "real life" patients. This pilot study will assess EPC response in patients that are able to undergo coronary intervention as part of their normal clinical management under current guidelines regardless of pre-existing comorbidities. The research team believe this will allow representation of "real world" patients.
Detailed description
This pilot study will include up to 40 patient-participants admitted into the coronary care unit of the Royal Stoke University Hospital a large and busy tertiary cardiac centre. Patient-participants will be assessed, and if deemed appropriate to undergo coronary angiography and or angioplasty will be eligible for enrolment in the study.
Following standard care angiogram / angioplasty, patient-participants will be given a minimum of 3 hours to consent to ensure that there is no delay in clinical treatment. A short information sheet will be given to the patient initially. If the patient is interested in the study, the full participant information sheet will be given. If potential patient-participants consent to study participation 3-5ml of blood will be venesected and sent for EPC analysis. That late evening atorvastatin 80mg will be given as per current national recommendations. Patient-participants will then have venesection for EPC analysis on days 1-2, 3-4 and finally 7-8. ACS patients are usually in hospital for 3 or 4 days provided there are no complications. It is therefore anticipated that days 0, 1-2 and 3-4 venesections may be performed whilst patient-participants are within the cardiology department. However an outpatient cardiology research clinic follow up will be arranged for day 7-8 to allow the final venesection for EPC analysis.
This pilot study will assess EPC response in patients that are able to undergo coronary intervention as part of their normal clinical management under current guidelines regardless of pre-existing comorbidities. The research team believe this will allow representation of "real world" patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood samples and Atorvastatin 80mg | Other | Drug: Atorvastatin, Other: Blood samplesAll participants are given Atorvastatin 80mg as part of their standard care. The main study intervention is blood samples at days 1-2, 3-4 and 7-8. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admitted with an acute coronary syndrome
- Are statin naive or receiving a statin other than atorvastatin, or atorvastatin at a dose less than 80mg daily
- Are able to give informed consent
- Have undergone coronary angiography/plasty
- Are able to attend follow up visits
Key exclusion criteria (3 listed)
- Atorvastatin is contraindicated (e.g. allergic to excipient)
- Women of child bearing potential unless they are using a recognised effective form of contraception or are not sexually active and have no intention of becoming sexually active during the course of the trial
- Women who are breastfeeding
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 |
|---|---|---|
| Atorvastatin | Drug | Blood samples and Atorvastatin 80mg |
| Blood samples3-5 mls of blood is taken at baseline and 3 subsequent timepoints and processed for Endothelial Progenitor Count (EPC). | Other | Blood samples and Atorvastatin 80mg |
Primary outcome
Number of EPCs (per microliter of blood) in patient-participants admitted with an ACS loaded with atorvastatin 80 mg
Time frame: 8 days
Number of EPCs (per microliter of blood) in patient-participants with different comorbid conditions
Time frame: 8 days
Number of EPCs (per microliter of blood) in participants who have been loaded or reloaded with atorvastatin
Time frame: 8 days
The time of onset of pain to loading/reloading strategies.
Time frame: 8 days
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 12 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Acute Coronary Syndrome
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Not yet recruitingPhase 4
Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia
Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
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.
Robert Butler principal investigator
University Hospitals of North Midlands NHS Trust
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 Atorvastatin and Blood samples in people with Acute Coronary Syndrome, run by University Hospitals of North Midlands NHS 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 5 inclusion and 3 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 12 Apr 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?
Number of EPCs (per microliter of blood) in patient-participants admitted with an ACS loaded with atorvastatin 80 mg (time frame: 8 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2019.