Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT00379418
• Lead Sponsor: Emory University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2006-09-19
• Study First Submitted QC: 2006-09-20
• Study First Posted: 2006-09-21
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-11
• Last Update Posted: 2013-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Atlanta VA Medical Center; 🇺🇸 Atlanta, Georgia, United States