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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01526824
Other study ID # PHP1061010A
Secondary ID
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


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
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