Study Stopped
Unable to find subjects that met inclusion/exclusion criteria.
PGD2 Formation in Vascular Injury
PGD2
Biosynthesis of PGD2 in Vascular Injury
2 other identifiers
observational
51
0 countries
N/A
Brief Summary
To investigate the biosynthesis of PGD2 during percutaneous transluminal coronary angioplasty (PTCA) procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2007
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 14, 2009
CompletedFirst Posted
Study publicly available on registry
October 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJune 11, 2019
June 1, 2019
3.5 years
October 14, 2009
June 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Study Arms (3)
No Aspirin Treatment
81 mg Aspirin Treatment
325 mg Aspirin
Interventions
Eligibility Criteria
Patients scheduled to have PTCA
You may qualify if:
- Patients with existing CAD admitted for elective PTCA:
- Treated with any dose of aspirin daily for at least 5 days, with special interest in those treated with 81 mg aspirin daily or
- Treated with an alternative antiplatelet therapy, such as clopidogrel, due to aspirin hypersensitivity or PMDs preference or
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
* 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.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Garret FitzGerald, MD
University of Pennsylvania
- PRINCIPAL INVESTIGATOR
Wenliang Song, MD
University of Pennsylvania
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2009
First Posted
October 26, 2009
Study Start
August 1, 2007
Primary Completion
February 1, 2011
Study Completion
January 1, 2012
Last Updated
June 11, 2019
Record last verified: 2019-06