Effects on endothelial progenitor cells by statins in all with acute coronary syndrome

The effect on Endothelial progenitor cells (EPCs) by statin loading in “all comers” with an Acute Coronary Syndrome (ACS). - Effect on EPCs by statin loading in 'all comers' with ACS

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000355-27-GB

Enrollment

Registered

2016-12-08

Start date

2016-03-10

Completion date

Unknown

Last updated

2016-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary syndrome MedDRA version: 19.0 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: atorvastatin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: atorvastatin CAS Number: 134523-03-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient-participants will be eligible for the study if they are; 1.1. Admitted with an acute coronary syndrome 2. Are statin naïve or receiving a statin other than atorvastatin, or atorvastatin at a dose less than 80mg daily. 3. Able to give informed consent 4. Have undergone coronary angiography / plasty 5. Able to attend follow up visits Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Patient-participants will be excluded if 1. Atorvastatin is contraindicated (e.g. allergic to excipient) 2. 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. 3. Women who are breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective The primary objectives of this study are to firstly to assess EPC response in patient-participants admitted with an ACS loaded with atorvastatin 80 mg. It will allow the study of: • loading verses reloading strategies in statin naïve vs non naïve patients. • time of onset of pain to loading/reloading strategies • assess if patient-participants with different comorbid conditions have different EPC response ;Secondary Objective: The results may allow consideration of further larger scale studies assessing EPC response in patients with multiple comorbidities. Present the finding in conferences and or publish in recognized journals;Primary end point(s): To assess if there is a correlation between EPC count and statin therapy in "all comer" patients presenting with an acute coronary syndrome (heart attack) in line with the study objectives.;Timepoint(s) of evaluation of this end point: 8 days	—

Measure

Time frame

Main Objective: Primary objective The primary objectives of this study are to firstly to assess EPC response in patient-participants admitted with an ACS loaded with atorvastatin 80 mg. It will allow the study of: • loading verses reloading strategies in statin naïve vs non naïve patients. • time of onset of pain to loading/reloading strategies • assess if patient-participants with different comorbid conditions have different EPC response ;Secondary Objective: The results may allow consideration of further larger scale studies assessing EPC response in patients with multiple comorbidities. Present the finding in conferences and or publish in recognized journals;Primary end point(s): To assess if there is a correlation between EPC count and statin therapy in "all comer" patients presenting with an acute coronary syndrome (heart attack) in line with the study objectives.;Timepoint(s) of evaluation of this end point: 8 days

—

Secondary

Measure	Time frame
Secondary end point(s): Presentation in conferences. Consideration of larger studies	—

Countries

United Kingdom

Contacts

Public ContactDr Darren Clement, R&D Manager

University Hospitals of North Midlands NHS Trust

darren.clement@uhns.nhs.uk01782675379

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026