Lovaza's Effect on Clopidogrel in a Neuro Population

Ischemic Stroke Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01526824
• Other study ID #: PHP1061010A
• Status: Recruiting
• Phase: Phase 0
• First received: January 31, 2012
• Last updated: February 1, 2012
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: February 2012
• Source: Millard Fillmore Gates Hospital
• Contact: Melissa Baxter, PharmD
• Phone: 716-887-4401
• Email: MBaxter[@]kaleidahealth.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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-

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Transient Ischemic Attack

Intervention

Dietary Supplement:
• omega-3 polyunsaturated fatty acids (Lovaza)
Lovaza, 1 gram orally daily

Locations

Country	Name	City	State
United States	Millmore Fillmore Gates Hospital	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Millard Fillmore Gates Hospital	Kaleida Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PRU and % inhibition of P2Y12 Assay		20-30 days after initiation of the study	No
Secondary	Neurologic events in each study		20-30 days after initiation of study	Yes
Secondary	HDL, triglycerides, LDL, or total cholesterol		20-30 days after initiation of the study	No
Secondary	Bleeding		20-30 days