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

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Emory University

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Drug: Abciximab

Study type

Observational

Funder types

Other

Identifiers

NCT00379418
IRB00021864

Details and patient eligibility

About

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.

Enrollment

220 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Have either:

    • clinical history of anginal symptoms or positive stress test or
    • in stent restenosis
  2. Have an angiographic >70% coronary artery stenosis that will be treated with coronary angioplasty or stenting procedure

  3. For at least four weeks prior to the procedure have been on, no Hmgcoa- reductase inhibitor or a stable statin dose

  4. negative pregnancy test

  5. are able to give informed consent

Exclusion criteria

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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