PGD2 Formation in Vascular Injury

Coronary Artery Disease Clinical Trial

— PGD2  

Official title:

Biosynthesis of PGD2 in Vascular Injury

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01001260
• Other study ID #: 804975
• Secondary ID: American Heart A
• Status: Terminated
• Start date: August 2007
• Est. completion date: January 2012

Study information

• Verified date: June 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To investigate the biosynthesis of PGD2 during percutaneous transluminal coronary angioplasty (PTCA) procedure.

Description:

A) To determine whether biosynthesis of PGD2 is altered in response to vascular injury in humans

B) Patients will be grouped base on their aspirin using status. Three groups of no aspirin but an alternative anti-platelet medicine, low dose (81 mg) aspirin, high dose 325 mg aspirin will be enrolled.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: January 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients with existing CAD admitted for elective PTCA:

1. Treated with any dose of aspirin daily for at least 5 days, with special interest in those treated with 81 mg aspirin daily or

2. Treated with an alternative antiplatelet therapy, such as clopidogrel, due to aspirin hypersensitivity or PMDs preference or

3. No aspirin therapy at all

• Patients presenting to the ER with Acute Coronary Syndrome(ACS)who will have a PTCA

• Patients with stable angina or positive stress tests scheduled for a cardiac catheterization

Exclusion Criteria:

• History of unstable diabetes (hgb A1c>8 or FBS> 200)

• Uncontrolled hypertension (SBP > 180, DBP >100)

• History of an acute confounding disease as judged on clinical screen that according to the investigator may interfere with interpretation of the study results, or compromise the safety of a potential subject.

• Patients who have taken NSAIDS or COX-2 inhibitors other than aspirin, for at least 10 days prior to PTCA

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Stable Angina
• Vascular System Injuries

Intervention

Drug:
• No ASA
Alternative antiplatelet therapy instead of aspirin
• Low dose ASA
Low dose aspirin (81mg) prior to PTCA
• 325 mg ASA
high dose of aspirin prior to PTCA

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The increment of PGD2 synthesis reflected by an novel biomarker of urinary PGD2 metabolite.		18-48 hours - which includes 24 hours before the procedure through 18 hours after the procedure for a continuous urine collection.
Secondary	Whether aspirin could blunt the increment of PGD2 if there is.		18-48 hours - which includes 24 hours before the procedure through 18 hours after the procedure for a continuous urine collection.