The Effect on EPCs by Statin Loading in "All Comers" With an ACS

NCT02957162 | Completed Phase 4

• 1 other identifier: 995
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (4)

• Number of EPCs (per microliter of blood) in patient-participants admitted with an ACS loaded with atorvastatin 80 mg

  8 days

• Number of EPCs (per microliter of blood) in patient-participants with different comorbid conditions

  8 days

• Number of EPCs (per microliter of blood) in participants who have been loaded or reloaded with atorvastatin

  8 days

• The time of onset of pain to loading/reloading strategies.

  8 days

Study Arms (1)

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.

Drug: Atorvastatin; Other: Blood samples

Interventions

Atorvastatin DRUG

Blood samples and Atorvastatin 80mg

Blood samples OTHER

3-5 mls of blood is taken at baseline and 3 subsequent timepoints and processed for Endothelial Progenitor Count (EPC).

Blood samples and Atorvastatin 80mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals of North Midlands NHS Trust: lead

Study Sites (1)

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Atorvastatin; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Robert Butler

  University Hospitals of North Midlands NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: November 7, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 25, 2017
• Last Updated: April 12, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)