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PGD2 Formation in Vascular Injury

Biosynthesis of PGD2 in Vascular Injury

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01001260
Acronym
PGD2
Enrollment
51
Registered
2009-10-26
Start date
2007-08-31
Completion date
2012-01-31
Last updated
2019-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Coronary Artery Disease, Stable Angina

Keywords

Prostaglandins, vascular injury

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.

Interventions

DRUG325 mg ASA

high dose of aspirin prior to PTCA

DRUGNo ASA

Alternative antiplatelet therapy instead of aspirin

Low dose aspirin (81mg) prior to PTCA

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026