Heart Valve Disease

Aortic Stenosis

Phytine (phytate)

Placebo

Hospital Universitario Son Dureta

Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications

Carlos Fernandez-Palomeque

Hospital Universitari Son Dureta

Laboratorios BIOMED SA

Patient is not on Aspirin, Clopidogrel, or Warfarin and is taking escalating doses of study drug.

Patient is on regular dose of Aspirin ( < or = 325mg). Patient is not taking Clopidogrel or Warfarin and is taking the escalating doses of Lovaza

Patient is taking regularly 75mg of clopidogrel daily and Aspirin (< or = 325mg) and not taking Warfarin and is taking the escalating doses of Lovaza

Patient is regularly taking Warfarin daily and Aspirin (< or = 325mg)and is not taking Clopidogrel and is taking the escalating doses of Lovaza

Group A: Subject is not on Aspirin, Clopidogrel, or Warfarin. Subject is taking escalating doses of study drug (Lovaza)over a 24 week period.

Group A: Subject on Lovaza Only

Group B: Subject on Aspirin (< or = 325mg and is not taking Clopidogrel or Warfarin. Subject is taking escalating doses of Lovaza over a 24 week period.

Group. B: Subject on Lovaza + Aspirin

Group C: Subject is taking Clopidogrel 75mg)and Aspirin (< or = 325mg) and not taking Warfarin. Subject is taking escalating doses of Lovaza over a 24 week period.

Group C: Subject on Lovaza + Clopidogrel + Aspirin

Group D: Subject is taking Warfarin and Aspirin (< or = 325mg)and is not taking Clopidogrel. Subject is taking escalating doses of Lovaza over a 24 week period.

Group D: Subject on Lovaza + Warfarin + Aspirin

Total

Gender

Region of Enrollment

The PAP-8E measures platelet aggregation in platelet rich plasma (PRP). Platelet responses to a series of common agonists cause changes in optical density that are measured. The instrument is blanked (100% baseline (optimal transmission)) by inserting a platelet poor plasma (PPP) specimen into the appropriate channel. The PRP is then inserted into the same well. The difference in optical density between the PPP and the PRP 0% baseline (optical transmission) is recorded for several minutes when the agonist reagent is added to the PRP.

Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.

Group B: Subject on study drug (Lovaza) plus Aspirin (< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.

Group B: Subject on Lovaza + Aspirin

Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.

Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.

Platelet Aggegation (Arachiodonic Acid)Using a PAP-8E (BioData Corp.)

was there any bleeding occurance during the accessed interval

The Occurence of Any Type of Bleeding

Bleeding time is a measure of how well platelets interact with blood vessel walls to form a clot. A manual blood pressure cuff is placed 2 inches above the antecubital fossa and inflated to 40mmHg. Using a standard Surgicutt device, a small incision is made and a stopwatch is started. The incision edge is blotted at 30 second intervals with standard filter paper until the bleeding has stopped. The time to hemostasis is noted.

Bleeding Time

Measurements were made using a modified device (EQELS) to specifications of constant current, high electric field and a scattering angle of 30 degrees. EQELS provides a sensitive assessment of subtle changes in the cell surface that occurs with activation, ligand binding or apoptosis. These changes are the result of different distributions of charged groups that define a surface charge finger print for the current state of activation of the cell. Resting state platelets have a negative surface charge, whereas fully activated platelets have a positive surface charge.

EQELS (Electrophoretic Quasi Elastic Light Scattering: Change in Mobility After the Addition of Arachidonic Acid

Group A: Subject is healthly and not on Aspirin, Clopidogrel, or Warfarin. Subjects will be taking escalating doses of the study drug (Lovaza)up to 24 weeks.

Group A: Subjects on Lovaza Only

Group B: Subject is only taking Aspirin (< or = 325mg) daily. Subjects will be taking escalating doses of study drug (Lovaza) in addition to aspirin up to 24 weeks.

Group B: Subjects on Lovaza Plus Aspirin

Subject is regularly taking Clopidogrel (75mg)and Aspirin (< or = 325mg)daily, and not taking Warfarin. Subjects will be taking escalating doses of study drug (Lovaza)in addition to Clopidogrel and Aspirin up to 24 weeks.

Group C: Subjects on Lovaza Plus Clopidogrel and Aspirin

Subject is regularly taking Warfarin and Aspirin (< or = 325mg)daily, and not taking Clopidogrel. Subjects will be taking escalating doses of study drug (Lovaza)in addition to Warfarin and Aspirin up to 24 weeks.

Group D: Subjects on Lovaza Plus Warfarin and Aspirin

Overall Study

Dr. Don A. Gabriel

Group A

Group B

Group C

Group D

Cardiovascular Disease

Bleeding

First 6 weeks period take 1 gram Lovaza capsule daily 2nd 6 weeks period take 2 grams of Lovaza (2 1 gram capsules) daily 3rd 6 weeks period take 4 grams of Lovaza (4 1 gram capsules) daily 4th 6 weeks period take 8 grams of Lovaza (8 1 gram capsules) daily

inositol/infark

Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications

Lovaza's Effect on the Activation of Platelets

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