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PGD2 Formation in Vascular Injury

This study has been terminated.
(Unable to find subjects that met inclusion/exclusion criteria.)
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01001260
First received: October 14, 2009
Last updated: January 31, 2013
Last verified: December 2011

October 14, 2009
January 31, 2013
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01001260 on ClinicalTrials.gov 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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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. There groups of no aspirin but an alternative anti-platelet medicine, low dose (81 mg) aspirin, high dose 325 mg aspirin will be enrolled.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
51
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01001260
804975, American Heart Association
No
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
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP