PGD2 Formation in Vascular Injury

Terminated

• Conditions: Stable Angina; Acute Coronary Syndrome; Coronary Artery Disease
• Interventions: Drug: No ASA; Drug: 325 mg ASA; Drug: Low dose ASA

• Registration Number: NCT01001260
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2009-10-14
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-26
• Primary Completion: 2011-02
• Study Completion: 2012-01
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-10
• Last Update Posted: 2019-06-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No Aspirin Treatment	No ASA	-
325 mg Aspirin	325 mg ASA	-
81 mg Aspirin Treatment	Low dose ASA	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.