- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02957162
The Effect on EPCs by Statin Loading in "All Comers" With an ACS (ALL COMERS)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
Staffordshire
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Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
- University Hospitals of North Midlands NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Blood samples and Atorvastatin 80mg
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.
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3-5 mls of blood is taken at baseline and 3 subsequent timepoints and processed for Endothelial Progenitor Count (EPC).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of EPCs (per microliter of blood) in patient-participants admitted with an ACS loaded with atorvastatin 80 mg
Time Frame: 8 days
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8 days
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Number of EPCs (per microliter of blood) in patient-participants with different comorbid conditions
Time Frame: 8 days
|
8 days
|
Number of EPCs (per microliter of blood) in participants who have been loaded or reloaded with atorvastatin
Time Frame: 8 days
|
8 days
|
The time of onset of pain to loading/reloading strategies.
Time Frame: 8 days
|
8 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Robert Butler, University Hospitals of North Midlands NHS Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Disease
- Syndrome
- Acute Coronary Syndrome
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
Other Study ID Numbers
- 995
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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