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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 14, 2009

Last Updated Date

January 31, 2013

Start Date ^ICMJE

August 2007

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01001260 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

PGD2 Formation in Vascular Injury

Official Title ^ICMJE

Biosynthesis of PGD2 in 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. There groups of no aspirin but an alternative anti-platelet medicine, low dose (81 mg) aspirin, high dose 325 mg aspirin will be enrolled.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

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.

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled to have PTCA

Condition ^ICMJE

Coronary Artery Disease
Acute Coronary Syndrome
Stable Angina

Intervention ^ICMJE

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

Study Group/Cohort (s)

No Aspirin Treatment
Intervention: Drug: No ASA
81 mg Aspirin Treatment
Intervention: Drug: Low dose ASA
325 mg Aspirin
Intervention: Drug: 325 mg ASA

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

January 2012

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01001260

Other Study ID Numbers ^ICMJE

804975, American Heart Association

Has Data Monitoring Committee

Responsible Party

University of Pennsylvania

Study Sponsor ^ICMJE

University of Pennsylvania

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Garret FitzGerald, MD	University of Pennsylvania
Principal Investigator:	Wenliang Song, MD	University of Pennsylvania

Information Provided By

University of Pennsylvania

Verification Date

December 2011

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

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