Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients - Full Text View

Sponsored by:	Emory University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00379418

Purpose

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:

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

Condition	Phase
Coronary Artery Disease	Phase I Phase II

MedlinePlus related topics: Angioplasty Coronary Artery Disease

Drug Information available for: Abciximab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Cross-Sectional, Defined Population, Prospective Study

Further study details as provided by Emory University:

Estimated Enrollment:	220
Study Start Date:	January 2003

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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 antagonistwithin four weeks.
treatment with thrombolytic therapy within 48 hours
MI within 2 months.
recent infections
general anesthesia within 3 months.
renal failure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379418

Contacts

Contact: Tanuj K Kamineni	404 712 0168	tkamine@emory.edu
Contact: Johnson Pereira, MD	404 712 0168	jpereir@emory.edu

Locations

United States, Georgia
Emory University Hospital	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Tanuj K Kamineni 404-712-0168 tkamine@meory.edu
Contact: Johnson Pereira, MD 404-712-0168 jpereir@emory.edu
Atlanta VA Medical Center	Recruiting
Atlanta, Georgia, United States, 30033
Contact: Kreton Mavromatis, MD 404-329-2207 kmavro@emory.edu
Contact: Padi K Reddy 4043216111 ext 6223

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator:

Arshed A Quyyumi, M.D.

EUH

More Information

Study ID Numbers:	812-2002
Study First Received:	September 19, 2006
Last Updated:	September 20, 2006
ClinicalTrials.gov Identifier:	NCT00379418
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Abciximab
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009