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The Effect on EPCs by Statin Loading in "All Comers" With an ACS (ALL COMERS)

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ClinicalTrials.gov Identifier: NCT02957162
Recruitment Status : Completed
First Posted : November 6, 2016
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospitals of North Midlands NHS Trust

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.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Atorvastatin Other: Blood samples Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect on Endothelial Progenitor Cells (EPCs) by Statin Loading in "All Comers" With an Acute Coronary Syndrome (ACS)
Study Start Date : March 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 25, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Atorvastatin
Other: Blood samples
3-5 mls of blood is taken at baseline and 3 subsequent timepoints and processed for Endothelial Progenitor Count (EPC).




Primary Outcome Measures :
  1. Number of EPCs (per microliter of blood) in patient-participants admitted with an ACS loaded with atorvastatin 80 mg [ Time Frame: 8 days ]
  2. Number of EPCs (per microliter of blood) in patient-participants with different comorbid conditions [ Time Frame: 8 days ]
  3. Number of EPCs (per microliter of blood) in participants who have been loaded or reloaded with atorvastatin [ Time Frame: 8 days ]
  4. The time of onset of pain to loading/reloading strategies. [ Time Frame: 8 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957162


Locations
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United Kingdom
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
Sponsors and Collaborators
University Hospitals of North Midlands NHS Trust
Investigators
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Principal Investigator: Robert Butler University Hospitals of North Midlands NHS Trust

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Responsible Party: University Hospitals of North Midlands NHS Trust
ClinicalTrials.gov Identifier: NCT02957162    
Other Study ID Numbers: 995
First Posted: November 6, 2016    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors