PGD2 Formation in Vascular Injury

NCT ID: NCT01001260

Last Updated: 2019-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2012-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Coronary Artery Disease Acute Coronary Syndrome Stable Angina

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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No Aspirin Treatment

No ASA

Intervention Type DRUG

Alternative antiplatelet therapy instead of aspirin

81 mg Aspirin Treatment

Low dose ASA

Intervention Type DRUG

Low dose aspirin (81mg) prior to PTCA

325 mg Aspirin

325 mg ASA

Intervention Type DRUG

high dose of aspirin prior to PTCA

Interventions

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No ASA

Alternative antiplatelet therapy instead of aspirin

Intervention Type DRUG

Low dose ASA

Low dose aspirin (81mg) prior to PTCA

Intervention Type DRUG

325 mg ASA

high dose of aspirin prior to PTCA

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Garret FitzGerald, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Wenliang Song, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Other Identifiers

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American Heart Association

Identifier Type: -

Identifier Source: secondary_id

804975

Identifier Type: -

Identifier Source: org_study_id

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