Hypercholesterolemia Clinical Trial
Official title:
The Effect of Serum LDL Lowering on Aspirin Resistance
Verified date | February 2013 |
Source | Ziv Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
Aspirin resistance is the persistent platelet activation, demonstrated by platelet function
tests (1).
The hypothesis is that:LDL lowering by statin in patients with aspirin resistance can
improve the effect of aspirin due to the potential decreasing of cholesterol content in the
platelet membranes.
Patients and methods:Forty hypercholesterolemic patients with aspirin resistance after 5
days of treatment with aspirin and high LDL and triglycerides<300 mg/dL, will be enrolled.
Ten healthy volunteers will be the control group.
Status | Completed |
Enrollment | 40 |
Est. completion date | January 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Hypercholesterolemic low-moderate risk patients without hypolipidemic drugs for at least one month. 2. Age =18 years on stable AHA step 1 diet. 3. For primary prevention, LDL > 130 mg/dL and for secondary prevention LDL>70 and <100mg/dL. . 4. CPK, ALT and AST < 1.5 x upper limit of normal at baseline. Exclusion Criteria: 1. Women currently receiving cyclical hormones. 2. Treatment with hypolipidemic drugs during the last month. 3. Oral corticosteroids, NSAID, COX-1 inhibitors and other antiplatelet drugs. 4. Women with childbearing potential unless on safe contraception. 5. Psychiatric disease with defect in judgement. 6. Severe renal or hepatic diease. 7. Uncontrolled hypo- or hyperthyroidism. 8. Contraindication for ezetimibe or statin treatment. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Internal Medicine Department A ,Ziv Goverment Hospital | Safed |
Lead Sponsor | Collaborator |
---|---|
Ziv Hospital |
Israel,
Ardlie NG, Selley ML, Simons LA. Platelet activation by oxidatively modified low density lipoproteins. Atherosclerosis. 1989 Apr;76(2-3):117-24. — View Citation
Bruno A, McConnell JP, Mansbach HH 3rd, Cohen SN, Tietjen GE, Bang NU. Aspirin and urinary 11-dehydrothromboxane B(2) in African American stroke patients. Stroke. 2002 Jan;33(1):57-60. — View Citation
CHIAMORI N, HENRY RJ. Study of the ferric chloride method for determination of total cholesterol and cholesterol esters. Am J Clin Pathol. 1959 Apr;31(4):305-9. — View Citation
Cipollone F, Ciabattoni G, Patrignani P, Pasquale M, Di Gregorio D, Bucciarelli T, Davì G, Cuccurullo F, Patrono C. Oxidant stress and aspirin-insensitive thromboxane biosynthesis in severe unstable angina. Circulation. 2000 Aug 29;102(9):1007-13. — View Citation
Jefferson BK, Foster JH, McCarthy JJ, Ginsburg G, Parker A, Kottke-Marchant K, Topol EJ. Aspirin resistance and a single gene. Am J Cardiol. 2005 Mar 15;95(6):805-8. — View Citation
Kamath S, Blann AD, Lip GY. Platelet activation: assessment and quantification. Eur Heart J. 2001 Sep;22(17):1561-71. Review. — View Citation
LOWRY OH, ROSEBROUGH NJ, FARR AL, RANDALL RJ. Protein measurement with the Folin phenol reagent. J Biol Chem. 1951 Nov;193(1):265-75. — View Citation
Mammen EF, Comp PC, Gosselin R, Greenberg C, Hoots WK, Kessler CM, Larkin EC, Liles D, Nugent DJ. PFA-100 system: a new method for assessment of platelet dysfunction. Semin Thromb Hemost. 1998;24(2):195-202. — View Citation
Osamah H, Mira R, Sorina S, Shlomo K, Michael A. Reduced platelet aggregation after fluvastatin therapy is associated with altered platelet lipid composition and drug binding to the platelets. Br J Clin Pharmacol. 1997 Jul;44(1):77-83. — View Citation
Patrono C. Aspirin resistance: definition, mechanisms and clinical read-outs. J Thromb Haemost. 2003 Aug;1(8):1710-3. Review. — View Citation
Reilly MP, Praticò D, Delanty N, DiMinno G, Tremoli E, Rader D, Kapoor S, Rokach J, Lawson J, FitzGerald GA. Increased formation of distinct F2 isoprostanes in hypercholesterolemia. Circulation. 1998 Dec 22-29;98(25):2822-8. — View Citation
Sanderson S, Emery J, Baglin T, Kinmonth AL. Narrative review: aspirin resistance and its clinical implications. Ann Intern Med. 2005 Mar 1;142(5):370-80. Review. — View Citation
Surya II, Akkerman JW. The influence of lipoproteins on blood platelets. Am Heart J. 1993 Jan;125(1):272-5. Review. — View Citation
* Note: There are 13 references in all — Click here to view all references
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