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
  Purpose

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


Condition Intervention
Coronary Artery Disease
Acute Coronary Syndrome
Stable Angina
Drug: No ASA
Drug: Low dose ASA
Drug: 325 mg ASA

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Biosynthesis of PGD2 in Vascular Injury

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen 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.


Enrollment: 51
Study Start Date: August 2007
Study Completion Date: January 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No Aspirin Treatment Drug: No ASA
Alternative antiplatelet therapy instead of aspirin
81 mg Aspirin Treatment Drug: Low dose ASA
Low dose aspirin (81mg) prior to PTCA
325 mg Aspirin Drug: 325 mg ASA
high dose of aspirin prior to PTCA

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. There groups of no aspirin but an alternative anti-platelet medicine, low dose (81 mg) aspirin, high dose 325 mg aspirin will be enrolled.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients scheduled to have PTCA

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001260

Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Garret FitzGerald, MD University of Pennsylvania
Principal Investigator: Wenliang Song, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01001260     History of Changes
Other Study ID Numbers: 804975, American Heart Association
Study First Received: October 14, 2009
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Prostaglandins
vascular injury

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Vascular System Injuries
Acute Coronary Syndrome
Wounds and Injuries
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 15, 2014