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TerminatedNCT01001260PGD2Updated Jun 11, 2019

PGD2 Formation in Vascular Injury

An observational study in Coronary Artery Disease, Acute Coronary Syndrome and Stable Angina, sponsored by University of Pennsylvania. Terminated. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-06-11.

Sponsored by University of Pennsylvania · Observational

Why this study was terminated
Unable to find subjects that met inclusion/exclusion criteria.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
51
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Coronary Artery Disease
  • Acute Coronary Syndrome
  • Stable Angina

Keywords

  • Prostaglandins
  • vascular injury
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 51 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients scheduled to have PTCA

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

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
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
51 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • No Aspirin Treatment

    Drug: No ASA

  • 81 mg Aspirin Treatment

    Drug: Low dose ASA

  • 325 mg Aspirin

    Drug: 325 mg ASA

Interventions

  • DrugNo ASA

    Alternative antiplatelet therapy instead of aspirin

  • DrugLow dose ASA

    Low dose aspirin (81mg) prior to PTCA

  • Drug325 mg ASA

    high dose of aspirin prior to PTCA

06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01001260
Lead sponsor
University of Pennsylvania
Responsible party
Sponsor
First posted
Oct 26, 2009
Start date
Aug 2007
Primary completion
Feb 2011
Completion
Jan 2012
Last update
Jun 11, 2019

Study contacts

Garret FitzGerald, MD
principal investigator · University of Pennsylvania
Wenliang Song, MD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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