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PGD2 Formation in Vascular Injury

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University of Pennsylvania

Status

Terminated

Conditions

Coronary Artery Disease
Stable Angina
Acute Coronary Syndrome

Treatments

Drug: Low dose ASA
Drug: No ASA
Drug: 325 mg ASA

Study type

Observational

Funder types

Other

Identifiers

NCT01001260
American Heart Association
804975

Details and patient eligibility

About

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

Full 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.

Enrollment

51 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

51 participants in 3 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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