The Effect on EPCs by Statin Loading in "All Comers" With an ACS (ALL COMERS)
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Atorvastatin
Blood samples
Sponsored by
About this trial
This is an interventional prevention trial for Acute Coronary Syndrome
Eligibility Criteria
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
Sites / Locations
- University Hospitals of North Midlands NHS Trust
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Blood samples and Atorvastatin 80mg
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of EPCs (per microliter of blood) in patient-participants admitted with an ACS loaded with atorvastatin 80 mg
Number of EPCs (per microliter of blood) in patient-participants with different comorbid conditions
Number of EPCs (per microliter of blood) in participants who have been loaded or reloaded with atorvastatin
The time of onset of pain to loading/reloading strategies.
Secondary Outcome Measures
Full Information
NCT ID
NCT02957162
First Posted
October 19, 2016
Last Updated
April 10, 2019
Sponsor
University Hospitals of North Midlands NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02957162
Brief Title
The Effect on EPCs by Statin Loading in "All Comers" With an ACS
Acronym
ALL COMERS
Official Title
The Effect on Endothelial Progenitor Cells (EPCs) by Statin Loading in "All Comers" With an Acute Coronary Syndrome (ACS)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals of North Midlands NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blood samples and Atorvastatin 80mg
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Type
Other
Intervention Name(s)
Blood samples
Intervention Description
3-5 mls of blood is taken at baseline and 3 subsequent timepoints and processed for Endothelial Progenitor Count (EPC).
Primary Outcome Measure Information:
Title
Number of EPCs (per microliter of blood) in patient-participants admitted with an ACS loaded with atorvastatin 80 mg
Time Frame
8 days
Title
Number of EPCs (per microliter of blood) in patient-participants with different comorbid conditions
Time Frame
8 days
Title
Number of EPCs (per microliter of blood) in participants who have been loaded or reloaded with atorvastatin
Time Frame
8 days
Title
The time of onset of pain to loading/reloading strategies.
Time Frame
8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Butler
Organizational Affiliation
University Hospitals of North Midlands NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of North Midlands NHS Trust
City
Stoke-on-Trent
State/Province
Staffordshire
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect on EPCs by Statin Loading in "All Comers" With an ACS
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