Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients

Coronary Artery Disease Clinical Trial

— AIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00379418
• Other study ID #: IRB00021864
• Status: Completed
• Phase: Phase 4
• First received: September 19, 2006
• Last updated: September 11, 2013
• Start date: January 2003
• Est. completion date: December 2009

Study information

• Verified date: September 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Abciximab

Locations

Country	Name	City	State
United States	Atlanta VA Medical Center	Atlanta	Georgia
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States,