Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients

NCT ID: NCT00379418

Last Updated: 2013-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Abciximab

Intervention Type DRUG

Other Intervention Names

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Reopro

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Kreton Mavromatis, MD, FACC

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arshed A Quyyumi, M.D.

Role: PRINCIPAL_INVESTIGATOR

EUH

Locations

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Atlanta VA Medical Center

Atlanta, Georgia, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00021864

Identifier Type: -

Identifier Source: org_study_id