Metabolic SyndromePhase 3NCT00465296
Ppar-Gamma EliminAtes Restenosis Longevity Study: PEARLS
A Phase 3 study testing rosiglitazone in people with Metabolic Syndrome, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
The primary objective of this clinical trial is to assess the efficacy of rosiglitazone on bare metal stent (BMS) in-stent restenosis measured as late lumen loss in patients with metabolic syndrome. The secondary parameter for evaluation of efficacy is binary restenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- rosiglitazone
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jul 2007
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient's age >/=18 years;
- Patients must meet MS definition, which means that each patient must meet at least 3 of listed requirements of MS:
- A waist circumference of 40 inches or more for men and 35 inches or more for women (measured across the belly);
- A blood pressure of 130/85 mm Hg or higher;
- A triglyceride level 150 mg/dl or above;
- A fasting blood glucose level greater than 110 mg/dl , but less than 126; and/or
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- A high density lipoprotein level (HDL) less than 40 mg/dl (men) or under 50 mg/dl (women).
- Patients eligible for PCI;
- Patients must receive at least one bare metal stent;
- The patient has stable or unstable angina with clinical evidence of ischemia (ECG, exercise test, etc.); and/or
- The patient is able and willing to conform to the requirements of the study including repeat angiographic follow-up at 9 months, and voluntarily signs an Informed Consent.
Who cannot join
- • Patient has experienced an ST-segment elevation myocardial infarction within the preceding 48 hours; Patient must have CPK and CK-MB <3 times upper limit of normal at the time of angioplasty and enrollment;
- Previously diagnosed with either type 1 or type 2 diabetes and controlling glucose by one or a combination of the following treatments: diet, oral anti-diabetic agents, or insulin;
- Patient had or plans to have CABG within 9 months;
- Ejection fraction <35%; class III-IV CHF;
- Active liver disease (ALT >2.5 times upper limit of normal);
- Women who are pregnant;
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- A platelet count of less than 100,000 cells/mm3;
- Impaired renal function (creatinine ≥2.5 mg/dL) or status post renal transplant;
- Recipient of heart transplant;
- Patient with a life expectancy less than 12 months;
- Known allergies to aspirin, clopidogrel bisulfate (PlavixR) and ticlopidine (TiclidR), heparin, bivalirudin, contrast, or pioglitazone, that cannot be medically managed;
- Any significant medical condition, which in the investigator's opinion, may interfere with the patient's optimal participation in the study;
- Currently participating in an investigational drug or another device study;
- Current use of any thiazolidinedione (Rosiglitazone (Avandia) or Poiglitazone (Actos).
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
The primary objective of this clinical trial is to assess the efficacy of rosiglitazone on bare metal stent (BMS) in-stent restenosis measured as late lumen loss in patients with metabolic syndrome.
The secondary parameter for evaluation of efficacy is binary restenosis.
The tertiary objective will be to assess the effect of rosiglitazone on major cardiac events (MACE; death, MI, CABG, and target vessel revascularization). The occurrence of in-stent restenosis for patients with metabolic syndrome who receive a DES in a non-target lesion will be assessed angiographically at 9 months.
Read the detailed description
This is a prospective, multicenter, double blind, randomized clinical trial of patients who present to the catheterization laboratory for PCI (elective or setting of ACS) and receive at least one bare metal stent.
Patients will be randomized on a 1:1 basis to receive either rosiglitazone or placebo for 9 months. Patients will be followed for 9 months post procedure. All patients will be required to have a repeat angiogram with optional IVUS analysis at 9 months.
- Conditions
- Metabolic Syndrome
- Being tested
- rosiglitazone
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosiglitazoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to assess the efficacy of rosiglitazone on bare metal stent (BMS) in-stent restenosis measured as late lumen loss in patients with metabolic syndrome.
Secondary outcomes (2)
The secondary parameter for evaluation of efficacy is binary restenosis.
The tertiary objective is to assess the effect of rosiglitazone on major cardiac events and target vessel revascularization).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startJan 2006
- Primary completionJul 2007
- Study completionJul 2007
Why it stopped: Funding Discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Ron Waksman, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465296
- Sponsor's protocol ID
- PEARLS
- Status last verified
- Apr 2007
- First submitted
- 23 Apr 2007
- Last updated
- 22 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ppar-Gamma EliminAtes Restenosis Longevity Study: PEARLS
- ClinicalTrials.gov ID
- NCT00465296
- Acronym / sponsor ID
- PEARLS
- Conditions
- Metabolic Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding Discontinued
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 25 Apr 2007 (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.
The primary objective of this clinical trial is to assess the efficacy of rosiglitazone on bare metal stent (BMS) in-stent restenosis measured as late lumen loss in patients with metabolic syndrome.
The secondary parameter for evaluation of efficacy is binary restenosis.
The tertiary objective will be to assess the effect of rosiglitazone on major cardiac events (MACE; death, MI, CABG, and target vessel revascularization). The occurrence of in-stent restenosis for patients with metabolic syndrome who receive a DES in a non-target lesion will be assessed angiographically at 9 months.
Detailed description
This is a prospective, multicenter, double blind, randomized clinical trial of patients who present to the catheterization laboratory for PCI (elective or setting of ACS) and receive at least one bare metal stent.
Patients will be randomized on a 1:1 basis to receive either rosiglitazone or placebo for 9 months. Patients will be followed for 9 months post procedure. All patients will be required to have a repeat angiogram with optional IVUS analysis at 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The patient's age >/=18 years;
- Patients must meet MS definition, which means that each patient must meet at least 3 of listed requirements of MS:
- Patients eligible for PCI;
- Patients must receive at least one bare metal stent;
- The patient has stable or unstable angina with clinical evidence of ischemia (ECG, exercise test, etc.); and/or
Key exclusion criteria (14 listed)
- • Patient has experienced an ST-segment elevation myocardial infarction within the preceding 48 hours; Patient must have CPK and CK-MB <3 times upper limit of normal at the time of angioplasty and enrollment;
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 |
|---|---|---|
| rosiglitazone | Drug | – |
Primary outcome
The primary objective is to assess the efficacy of rosiglitazone on bare metal stent (BMS) in-stent restenosis measured as late lumen loss in patients with metabolic syndrome.
2 secondary outcomes
The secondary parameter for evaluation of efficacy is binary restenosis.
The tertiary objective is to assess the effect of rosiglitazone on major cardiac events and target vessel revascularization).
Results and safety
The study was stopped early (reason given: Funding Discontinued). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2008.
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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.
Ron Waksman, MD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rosiglitazone in people with Metabolic Syndrome, run by Medstar Health Research Institute at 1 site in United States.
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 11 inclusion and 14 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 22 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding Discontinued). 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 primary objective is to assess the efficacy of rosiglitazone on bare metal stent (BMS) in-stent restenosis measured as late lumen loss in patients with metabolic syndrome.. 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 22 May 2008.