Ischemic StrokeEarly Phase 1NCT01526824
Lovaza's Effect on Clopidogrel in a Neuro Population
A Early Phase 1 study testing omega-3 polyunsaturated fatty acids (Lovaza) in people with Ischemic Stroke and Transient Ischemic Attack, run by Millard Fillmore Gates Hospital at 1 site in United States.
Trial summary
In patients who have suffered an ischemic stroke or TIA (mini-stroke), as well as in patients who are candidates for neuroendovascular stenting, it is standard of care to treat these patients with antiplatelet therapy, or "blood-thinners", the most common of which is clopidogrel (Plavix) with or without the addition… Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Ischemic Stroke, Transient Ischemic Attack
- What is being tested?
- omega-3 polyunsaturated fatty acids (Lovaza)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2013
- Phase
- Early Phase 1
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gender: Male and female
- Age range: 25 - 80 years of age
- Study population: Patients who require antiplatelet therapy with clopidogrel +/- aspirin who are candidates for neuroendovascular stenting or have had an ischemic stroke/TIA.
- Eligible females will be: Non-pregnant nor lactating/breastfeeding; Be surgically sterile for at least 6 months, postmenopausal, or if heterosexually active and of childbearing potential, agree to continue to use an accepted method of birth control throughout the study.
Who cannot join
- Any clinically significant abnormal finding uncovered during the physical examination and/or clinically significant abnormal laboratory result at screening according to the clinical judgment of the Investigators
- Current alcohol abuse
- Smokers unable to refrain from smoking during the clinical trial
- Patients who are already taking anticoagulants or other antiplatelets (ticlopidine, prasugrel, dipyridamole, cilostazol), or patients already taking PUFAs
- Patients taking medications known to interact with clopidogrel that cannot be held or changed due to increased risk of adverse health events.
- Cytochrome P450 3A4 and 2C19 (CYP3A4, CYP2C19) inhibitors or substrates known to cause competitive inhibition
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- Proton pump inhibitors (PPIs)
- NSAIDs
- Pregnant women or lactating/breastfeeding women.
- Active or recent major bleeding (within 14 days) using TIMI score (minor severity will be acceptable based on clinical examination/patient history)
- Major severity-
- Intracranial hemorrhage
- Cardiac tamponade
- Overt bleeding with a decrease in hemoglobin ≥ 5 g/dl or a decrease in hematocrit ≥ 15% (with or without an identifiable site)
- Minor severity-
- Spontaneous gross hematuria
- Spontaneous hematemesis
- Spontaneous hemoptysis
- Observed bleeding with decrease in hemoglobin ≥ 3 g/dl but ≤ 5 g/dl (with an identifiable site)
- History of gastric or duodenal ulcer
- Platelet count < 100 x 109/L
- Serum creatinine > 2 mg/dL
- Liver injury (alanine transaminase level > 1.5 times upper limit of normal)
- Recent surgery (within 14 days of study screening)
- Known bleeding diathesis including but not limited to
- Hemophilia
- Von Willebrand disease
- Leukemia
- Clotting factor deficiencies
- Uncontrolled hypertension
- Sustained systolic blood pressure > 185 mmHg, despite treatment
- Sustained diastolic blood pressure > 110 mmHg, despite treatment
- Hypersensitivity or intolerance to clopidogrel, aspirin, PUFAs and/or documented fish allergy
- Patients who are currently enrolled in a different study or who have taken an investigational medication 30 days prior to starting this study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Millmore Fillmore Gates Hospital
Buffalo, New York, 14209
Melissa Baxter, PharmD, MBaxter@kaleidahealth.org
Robert Sawyer, MD
About this study
Official title: The Effects of Polyunsaturated Omega-3 Fatty Acids (Lovaza) on Patients Taking Clopidogrel +/- Aspirin Who Have Suffered an Ischemic Stroke/TIA and/or Are Candidates for Neuroendovascular Stenting.
In patients who have suffered an ischemic stroke or TIA (mini-stroke), as well as in patients who are candidates for neuroendovascular stenting, it is standard of care to treat these patients with antiplatelet therapy, or "blood-thinners", the most common of which is clopidogrel (Plavix) with or without the addition of aspirin. A relatively common problem encountered with these patients is non-responsiveness to clopidogrel therapy. A prior study in cardiac patients showed that the addition of omega-3 polyunsaturated fatty acids (Lovaza, or "fish oil") can increase a patient's response to therapy with clopidogrel, but there have been no studies in neuro patients. In this study, patients will be divided into one of two groups: in the study arm, patients will receive clopidogrel +/- aspirin as well as Lovaza. In the control arm, patients will only receive clopidogrel +/- aspirin. Assays will be done to measure responsiveness to clopdiogrel on days 0, 12-24 hours after loading dose, day 3-5 if still inpatient, and at a follow-up visit 20-30 days after the start of the study. The investigators believe that this study will show an increase in platelet aggregation in patients receiving both clopidogrel and Lovaza.
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Being tested
- omega-3 polyunsaturated fatty acids (Lovaza)
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 polyunsaturated fatty acids (Lovaza)Dietary supplement
Lovaza, 1 gram orally daily
| Study group | Role | What they receive |
|---|---|---|
| Control arm, clopidogrel without Lovaza | No intervention | These patients will be receiving standard of care therapy with either standard dose (75mg daily) or high dose (150mg daily) clopidogrel +/- aspirin based on physician discretion. |
| Clopidogrel plus Lovaza | Experimental | This is the study arm of the trial, in which patients will be receiving either a standard dose (75mg daily) or high dose (150mg daily) clopidogrel with or without aspirin as well as therapy with daily Lovaza. Receives: Dietary Supplement: omega-3 polyunsaturated fatty acids (Lovaza) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRU and % inhibition of P2Y12 Assay
Measured: 20-30 days after initiation of the study
Secondary outcomes (3)
Neurologic events in each study
Measured: 20-30 days after initiation of study
HDL, triglycerides, LDL, or total cholesterol
Measured: 20-30 days after initiation of the study
Bleeding
Measured: 20-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Millard Fillmore Gates Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kaleida Health
- Responsible party
- Principal investigator, Melissa Baxter, Millard Fillmore Gates Hospital
- Investigators
- Melissa Baxter, PharmD, Principal investigator, Millmore Fillmore Gates Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526824
- Sponsor's protocol ID
- PHP1061010A
- Status last verified
- Feb 2012
- First submitted
- 31 Jan 2012
- Last updated
- 6 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Polyunsaturated Omega-3 Fatty Acids (Lovaza) on Patients Taking Clopidogrel +/- Aspirin Who Have Suffered an Ischemic Stroke/TIA and/or Are Candidates for Neuroendovascular Stenting.
- ClinicalTrials.gov ID
- NCT01526824
- Acronym / sponsor ID
- PHP1061010A
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Millard Fillmore Gates HospitalUniversity, hospital or other
- Collaborators
- Kaleida Health
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 6 Feb 2012 (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.
In patients who have suffered an ischemic stroke or TIA (mini-stroke), as well as in patients who are candidates for neuroendovascular stenting, it is standard of care to treat these patients with antiplatelet therapy, or "blood-thinners", the most common of which is clopidogrel (Plavix) with or without the addition of aspirin. A relatively common problem encountered with these patients is non-responsiveness to clopidogrel therapy. A prior study in cardiac patients showed that the addition of omega-3 polyunsaturated fatty acids (Lovaza, or "fish oil") can increase a patient's response to therapy with clopidogrel, but there have been no studies in neuro patients. In this study, patients will be divided into one of two groups: in the study arm, patients will receive clopidogrel +/- aspirin as well as Lovaza. In the control arm, patients will only receive clopidogrel +/- aspirin. Assays will be done to measure responsiveness to clopdiogrel on days 0, 12-24 hours after loading dose, day 3-5 if still inpatient, and at a follow-up visit 20-30 days after the start of the study. The investigators believe that this study will show an increase in platelet aggregation in patients receiving both clopidogrel and Lovaza.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm, clopidogrel without Lovaza | No intervention | –These patients will be receiving standard of care therapy with either standard dose (75mg daily) or high dose (150mg daily) clopidogrel +/- aspirin based on physician discretion. |
| Clopidogrel plus Lovaza | Experimental | Dietary Supplement: omega-3 polyunsaturated fatty acids (Lovaza)This is the study arm of the trial, in which patients will be receiving either a standard dose (75mg daily) or high dose (150mg daily) clopidogrel with or without aspirin as well as therapy with daily Lovaza. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Gender: Male and female
- Age range: 25 - 80 years of age
- Study population: Patients who require antiplatelet therapy with clopidogrel +/- aspirin who are candidates for neuroendovascular stenting or have had an ischemic stroke/TIA.
- Eligible females will be: Non-pregnant nor lactating/breastfeeding; Be surgically sterile for at least 6 months, postmenopausal, or if heterosexually active and of childbearing potential, agree to continue to use an accepted method of birth control throughout the study.
Key exclusion criteria (34 listed)
- Any clinically significant abnormal finding uncovered during the physical examination and/or clinically significant abnormal laboratory result at screening according to the clinical judgment of the Investigators
- Current alcohol abuse
- Smokers unable to refrain from smoking during the clinical trial
- Patients who are already taking anticoagulants or other antiplatelets (ticlopidine, prasugrel, dipyridamole, cilostazol), or patients already taking PUFAs
- Patients taking medications known to interact with clopidogrel that cannot be held or changed due to increased risk of adverse health events.
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 |
|---|---|---|
| omega-3 polyunsaturated fatty acids (Lovaza)Lovaza, 1 gram orally daily | Dietary supplement | Clopidogrel plus Lovaza |
Primary outcome
PRU and % inhibition of P2Y12 Assay
Time frame: 20-30 days after initiation of the study
3 secondary outcomes
Neurologic events in each study
Time frame: 20-30 days after initiation of study
HDL, triglycerides, LDL, or total cholesterol
Time frame: 20-30 days after initiation of the study
Bleeding
Time frame: 20-30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2012.
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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.
Melissa Baxter, PharmD principal investigator
Millmore Fillmore Gates Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing omega-3 polyunsaturated fatty acids (Lovaza) in people with Ischemic Stroke and Transient Ischemic Attack, run by Millard Fillmore Gates Hospital 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 4 inclusion and 34 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: status not confirmed, as of the sponsor's last update on 6 Feb 2012. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melissa Baxter, PharmD (716-887-4401, MBaxter@kaleidahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRU and % inhibition of P2Y12 Assay (time frame: 20-30 days after initiation of the study). 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 6 Feb 2012.