Coronary Artery DiseasePGD2NCT01001260
PGD2 Formation in Vascular Injury
An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by University of Pennsylvania.
Trial summary
To investigate the biosynthesis of PGD2 during percutaneous transluminal coronary angioplasty (PTCA) procedure. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndrome, Stable Angina
- What is being tested?
- No ASA, Low dose ASA and 325 mg ASA
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to have PTCA
Who may be able to join
- Patients with existing CAD admitted for elective PTCA:
- Treated with any dose of aspirin daily for at least 5 days, with special interest in those treated with 81 mg aspirin daily or
- Treated with an alternative antiplatelet therapy, such as clopidogrel, due to aspirin hypersensitivity or PMDs preference or
- 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
Who cannot join
- 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
About this study
Official title: Biosynthesis of PGD2 in Vascular Injury
To investigate the biosynthesis of PGD2 during percutaneous transluminal coronary angioplasty (PTCA) procedure.
Read the detailed description
- To determine whether biosynthesis of PGD2 is altered in response to vascular injury in humans
- 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.
- Being tested
- No ASA, Low dose ASA, 325 mg ASA
- Keywords
- Prostaglandins, vascular injury
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome, Angina, Stable, Vascular System Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No ASADrug
Alternative antiplatelet therapy instead of aspirin
Low dose ASADrug
Low dose aspirin (81mg) prior to PTCA
325 mg ASADrug
high dose of aspirin prior to PTCA
| Study group | Role | What they receive |
|---|---|---|
| No Aspirin Treatment | Not described Receives: Drug: No ASA | |
| 81 mg Aspirin Treatment | Not described Receives: Drug: Low dose ASA | |
| 325 mg Aspirin | Not described Receives: Drug: 325 mg ASA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The increment of PGD2 synthesis reflected by an novel biomarker of urinary PGD2 metabolite.
Measured: 18-48 hours - which includes 24 hours before the procedure through 18 hours after the procedure for a continuous urine collection.
Secondary outcomes (1)
Whether aspirin could blunt the increment of PGD2 if there is.
Measured: 18-48 hours - which includes 24 hours before the procedure through 18 hours after the procedure for a continuous urine collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2009 (estimated)
- Study startAug 2007
- Primary completionFeb 2011
- Study completionJan 2012
Why it stopped: Unable to find subjects that met inclusion/exclusion criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Garret FitzGerald, MD, Principal investigator, University of PennsylvaniaWenliang Song, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001260
- Sponsor's protocol ID
- 804975
- Other IDs
- American Heart Association
- Acronym
- PGD2
- Status last verified
- Jun 2019
- First submitted
- 14 Oct 2009
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biosynthesis of PGD2 in Vascular Injury
- ClinicalTrials.gov ID
- NCT01001260
- Acronym / sponsor ID
- PGD2 / 804975
- Keywords
- Prostaglandins, vascular injury
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to find subjects that met inclusion/exclusion criteria.
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the biosynthesis of PGD2 during percutaneous transluminal coronary angioplasty (PTCA) procedure.
Detailed description
- To determine whether biosynthesis of PGD2 is altered in response to vascular injury in humans
- 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Aspirin Treatment | – | Drug: No ASA |
| 81 mg Aspirin Treatment | – | Drug: Low dose ASA |
| 325 mg Aspirin | – | Drug: 325 mg ASA |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to have PTCA
Key inclusion criteria (6 listed)
- Patients with existing CAD admitted for elective PTCA:
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No ASAAlternative antiplatelet therapy instead of aspirin | Drug | No Aspirin Treatment |
| Low dose ASALow dose aspirin (81mg) prior to PTCA | Drug | 81 mg Aspirin Treatment |
| 325 mg ASAhigh dose of aspirin prior to PTCA | Drug | 325 mg Aspirin |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study was stopped early (reason given: Unable to find subjects that met inclusion/exclusion criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garret FitzGerald, MD principal investigator
University of Pennsylvania
Wenliang Song, MD principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by University of Pennsylvania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to find subjects that met inclusion/exclusion criteria.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.