PGD2 Formation in Vascular Injury | NCT01001260

Studies
PGD2 Formation in Vascular Injury

NCT01001260

Sponsor

University of Pennsylvania

Status

Terminated

Last Update Posted

Jun 11, 2019Actual

Enrollment

51Actual

Phase

Not provided

Conditions

Coronary Artery Disease
Acute Coronary Syndrome
Stable Angina

Interventions

No ASA
Low dose ASA
325 mg ASA

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
American Heart Association

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to find subjects that met inclusion/exclusion criteria.

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Feb 2011Actual

Completion Date

Jan 2012Actual

First Submitted Date

Oct 14, 2009

First Submission Date that Met QC Criteria

Oct 22, 2009

First Posted Date

Oct 26, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2019

Last Update Posted Date

Jun 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No Aspirin Treatment			Drug: No ASA
81 mg Aspirin Treatment			Drug: Low dose ASA
325 mg Aspirin			Drug: 325 mg ASA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No ASA	Drug	Alternative antiplatelet therapy instead of aspirin	No Aspirin Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time 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 Outcomes

Measure	Description	Time 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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Patients scheduled to have PTCA

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Garret FitzGerald, MD	University of Pennsylvania	Principal Investigator
Wenliang Song, MD	University of Pennsylvania	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D054058	Acute Coronary Syndrome
D060050	Angina, Stable
D057772	Vascular System Injuries

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C098312	nitroxy-butyl-acetylsalicylic acid
D001241	Aspirin

Ancestor Terms

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives

Browse Leaves

Not provided

Browse Branches

Not provided

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.