Lovaza's Effect on Clopidogrel in a Neuro Population

Early Phase 1

• Conditions: Ischemic Stroke; Transient Ischemic Attack
• Interventions: Dietary Supplement: omega-3 polyunsaturated fatty acids (Lovaza)

• Registration Number: NCT01526824
• Lead Sponsor: Millard Fillmore Gates Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-01-31
• Status Verified: 2012-02
• Study First Submitted QC: 2012-02-01
• Last Update Submitted: 2012-02-01
• Study First Posted: 2012-02-06
• Last Update Posted: 2012-02-06
• Primary Completion: 2013-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clopidogrel plus Lovaza	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.

Primary Outcome Measures

Name	Time	Method
PRU and % inhibition of P2Y12 Assay	20-30 days after initiation of the study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Millmore Fillmore Gates Hospital; 🇺🇸 Buffalo, New York, United States