PGD2 Formation in Vascular Injury (PGD2)

Biosynthesis of PGD2 in Vascular Injury

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

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Stable Angina
• Intervention / Treatment: Drug: No ASA; Drug: Low dose ASA; Drug: 325 mg ASA

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.

• Study Type: Observational
• Enrollment (Actual): 51

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to have PTCA

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Garret FitzGerald, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: October 14, 2009
• First Submitted That Met QC Criteria: October 22, 2009
• First Posted (Estimate): October 26, 2009

Study Record Updates

• Last Update Posted (Actual): June 11, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: vascular injury; Prostaglandins
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Coronary Disease; Chest Pain; Angina Pectoris; Coronary Artery Disease; Acute Coronary Syndrome; Angina, Stable; Vascular System Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 804975; American Heart Association (Other Grant/Funding Number: 14CRP19880025)