NCT00911339

Brief Summary

The purpose of this study is to evaluate the extent of the mobilization of endothelial progenitor cells induced by low versus high dose atorvastatin after 4 weeks of treatment, in patients treated with anti-CD 34 antibodies coated stent.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2021

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

12.4 years

First QC Date

May 29, 2009

Last Update Submit

August 30, 2021

Conditions

Stable Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • To evaluate the extent of the mobilization of endothelial progenitor cells induced by low versus high dose atorvastatin after 4 weeks of treatment, in patients treated with anti-CD 34 antibodies coated stent.

    7-28-90 days after enrollment

Study Arms (2)

Atorvastatin 10 mg

ACTIVE COMPARATOR
Drug: Atorvastatin

Atorvastatin 80 mg

ACTIVE COMPARATOR
Drug: Atorvastatin

Interventions

AtorvastatinDRUG

Atorvastatin 10 mg associated with stent genous

Atorvastatin 10 mg

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 18 and 75 years
  • stable angina or silent ischemia
  • documented CAD
  • signed written informed consent

You may not qualify if:

  • current or recent therapy (stop \< 3 months) with statins
  • allergy to ASA or ticlopidine/clopidogrel
  • myocardial infarction (\< 3 months)
  • recent significant trauma or surgical interventions (\< 3 mesi)
  • significant renal or hepatic diseases
  • coagulative-hematological disorders
  • cancer
  • inflammatory diseases
  • myopathy
  • pregnancy (a pregnancy test will be performed in fertile women)
  • severe coronary calcification, or small vessels disease (\< 2.5 mm), long lesions (\> 20 mm), ostial lesions, bifurcation lesions requesting treatment of the collateral vessel, multi-vessel disease requiring PCI before the completion of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Irccs Policlinico San Matteo

Pavia, 27100, Italy

Location

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 29, 2009

First Posted

June 1, 2009

Study Start

January 1, 2009

Primary Completion

May 13, 2021

Study Completion

May 13, 2021

Last Updated

August 31, 2021

Record last verified: 2021-08

Locations

IT(1)