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Clinical Trials/NCT00379418
NCT00379418CompletedNot Applicable

Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients (AIR)

Emory University2 sites in 1 country220 target enrollmentStarted: January 2003Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
220
Locations
2
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

AIR STUDY

TITLE: Anti-Ischemic effects of Abciximab(Reopro)

PATIENT POPULATION: Patients undergoing PCI(an interventional procedure placing a small stent/metallic tube to keep a narrowed artery in your heart open) and either on a stable statin dose or not on a statin. Statin= cholesterol lowering drug(ie, lipitor, zocor).

INTERVENTION: Heparin vs. heparin + abciximab during PCI

PURPOSE: Measure the effects of abciximab on special healing blood stem cells (EPC's-Endothelial Progenitor Cells), on inflammation, on oxidative stress and on microvascular blood flow.

PATIENT ASSESSMENT:

  1. 50ccs blood draw on day 1(from sheath), day 2 ,day 7 and day 28.
  2. Measurement of blood flow in selected suitable patients
  3. 10 minute questionnaire before discharge and on visit on day 28.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Have either:
  • •clinical history of anginal symptoms or positive stress test or
  • •in stent restenosis
  • •Have an angiographic >70% coronary artery stenosis that will be treated with coronary angioplasty or stenting procedure
  • •For at least four weeks prior to the procedure have been on, no Hmgcoa- reductase inhibitor or a stable statin dose
  • •negative pregnancy test
  • •are able to give informed consent

Exclusion Criteria

  • •Coronary intervention within four weeks prior to enrollment.
  • •Treatment with abciximab antagonist within four weeks.
  • •treatment with thrombolytic therapy within 48 hours
  • •MI within 2 months.
  • •recent infections
  • •general anesthesia within 3 months.
  • •renal failure

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kreton Mavromatis, MD, FACC

Assistant Professor

Emory University

Study Sites (2)

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