PGD2 Formation in Vascular Injury (PGD2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01001260
Recruitment Status : Terminated (Unable to find subjects that met inclusion/exclusion criteria.)
First Posted : October 26, 2009
Last Update Posted : March 20, 2018
Information provided by (Responsible Party):
University of Pennsylvania

October 14, 2009
October 26, 2009
March 20, 2018
August 2007
February 2011   (Final data collection date for primary outcome measure)
The increment of PGD2 synthesis reflected by an novel biomarker of urinary PGD2 metabolite. [ Time Frame: 18-48 hours - which includes 24 hours before the procedure through 18 hours after the procedure for a continuous urine collection. ]
Same as current
Complete list of historical versions of study NCT01001260 on Archive Site
Whether aspirin could blunt the increment of PGD2 if there is. [ Time Frame: 18-48 hours - which includes 24 hours before the procedure through 18 hours after the procedure for a continuous urine collection. ]
Same as current
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PGD2 Formation in Vascular Injury
Biosynthesis of PGD2 in Vascular Injury
To investigate the biosynthesis of PGD2 during percutaneous transluminal coronary angioplasty (PTCA) procedure.

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.

Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
  • Specimens:

    3 urine collections will be obtained (Prior to PTCA, During PTCA and Post PTCA)

  • Genetic Testing:

analysis of the association of SNPs in Cox genes with variability in selectively or in the PGEs genes in quantitative biosynthesis of PGD2 and related compounds.

Non-Probability Sample
Patients scheduled to have PTCA
  • Coronary Artery Disease
  • Acute Coronary Syndrome
  • Stable Angina
  • Drug: No ASA
    Alternative antiplatelet therapy instead of aspirin
  • Drug: Low dose ASA
    Low dose aspirin (81mg) prior to PTCA
  • Drug: 325 mg ASA
    high dose of aspirin prior to PTCA
  • No Aspirin Treatment
    Intervention: Drug: No ASA
  • 81 mg Aspirin Treatment
    Intervention: Drug: Low dose ASA
  • 325 mg Aspirin
    Intervention: Drug: 325 mg ASA
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2012
February 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
American Heart Association
Not Provided
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University of Pennsylvania
University of Pennsylvania
Not Provided
Principal Investigator: Garret FitzGerald, MD University of Pennsylvania
Principal Investigator: Wenliang Song, MD University of Pennsylvania
University of Pennsylvania
March 2018