Lovaza's Effect on Clopidogrel in a Neuro Population

NCT01526824 | Unknown Early Phase 1

• 1 other identifier: PHP1061010A
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• PRU and % inhibition of P2Y12 Assay

  20-30 days after initiation of the study

Secondary Outcomes (3)

• Neurologic events in each study

  20-30 days after initiation of study

• HDL, triglycerides, LDL, or total cholesterol

  20-30 days after initiation of the study

• Bleeding

  20-30 days

Study Arms (2)

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.

Dietary Supplement: omega-3 polyunsaturated fatty acids (Lovaza)

Interventions

omega-3 polyunsaturated fatty acids (Lovaza) DIETARY_SUPPLEMENT

Lovaza, 1 gram orally daily

Clopidogrel plus Lovaza

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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-

Sponsors & Collaborators

• Millard Fillmore Gates Hospital: lead
• Kaleida Health: collaborator

Study Sites (1)

Millmore Fillmore Gates Hospital

Buffalo, New York, 14209, United States

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient

Interventions

Docosahexaenoic Acids; Omacor

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Melissa Baxter, PharmD

  Millmore Fillmore Gates Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Baxter, PharmD

CONTACT

716-887-4401; MBaxter@kaleidahealth.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neuroscience Clinical Pharmacy Coordinator

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: February 6, 2012
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 6, 2012

Record last verified: 2012-02

Locations

US (1)