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Lovaza's Effect on Clopidogrel in a Neuro Population

Primary Purpose

Ischemic Stroke, Transient Ischemic Attack

Status

Unknown status

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

omega-3 polyunsaturated fatty acids (Lovaza)

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Millmore Fillmore Gates HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control arm, clopidogrel without Lovaza

Clopidogrel plus Lovaza

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

PRU and % inhibition of P2Y12 Assay

Secondary Outcome Measures

Neurologic events in each study

HDL, triglycerides, LDL, or total cholesterol

Bleeding

Full Information

NCT ID

NCT01526824

First Posted

January 31, 2012

Last Updated

February 1, 2012

Sponsor

Millard Fillmore Gates Hospital

Collaborators

Kaleida Health

1. Study Identification

Unique Protocol Identification Number

NCT01526824

Brief Title

Lovaza's Effect on Clopidogrel in a Neuro Population

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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Millard Fillmore Gates Hospital

Collaborators

Kaleida Health

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke, Transient Ischemic Attack

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control arm, clopidogrel without Lovaza

Arm Type

No Intervention

Arm Description

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.

Arm Title

Clopidogrel plus Lovaza

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

omega-3 polyunsaturated fatty acids (Lovaza)

Intervention Description

Lovaza, 1 gram orally daily

Primary Outcome Measure Information:

Title

PRU and % inhibition of P2Y12 Assay

Time Frame

20-30 days after initiation of the study

Secondary Outcome Measure Information:

Title

Neurologic events in each study

Time Frame

20-30 days after initiation of study

Title

HDL, triglycerides, LDL, or total cholesterol

Time Frame

20-30 days after initiation of the study

Title

Bleeding

Time Frame

20-30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Melissa Baxter, PharmD

Phone

716-887-4401

MBaxter@kaleidahealth.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Melissa Baxter, PharmD

Organizational Affiliation

Millmore Fillmore Gates Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Millmore Fillmore Gates Hospital

City

Buffalo

State/Province

New York

ZIP/Postal Code

14209

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Melissa Baxter, PharmD

MBaxter@kaleidahealth.org

First Name & Middle Initial & Last Name & Degree

Robert Sawyer, MD

First Name & Middle Initial & Last Name & Degree

Adnan H Siddiqui, MD, PhD

First Name & Middle Initial & Last Name & Degree

Elad I Levy, MD, FACS, FAHA

First Name & Middle Initial & Last Name & Degree

L N Hopkins, MD

First Name & Middle Initial & Last Name & Degree

Ken Snyder, MD, PhD

First Name & Middle Initial & Last Name & Degree

Travis Dumont, MD

First Name & Middle Initial & Last Name & Degree

Shannon O'Brien, MD

First Name & Middle Initial & Last Name & Degree

Naveen Sajja, MD

12. IPD Sharing Statement

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Lovaza's Effect on Clopidogrel in a Neuro Population

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