NCT00466154

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
Last Updated

February 20, 2013

Status Verified

February 1, 2013

First QC Date

April 25, 2007

Last Update Submit

February 19, 2013

Conditions

Aspirin ResistanceHypercholesterolemia

Keywords

Aspirin resistancePlatelet activationHypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Spearsman's correlation coefficients will be calculated to determine the relation between changes in lipid parameters and changes in LDL tendency to oxidation and platelet aggregation.

Interventions

AspirinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypercholesterolemic low-moderate risk patients without hypolipidemic drugs for at least one month.
  • Age ≥18 years on stable AHA step 1 diet.
  • For primary prevention, LDL \> 130 mg/dL and for secondary prevention LDL\>70 and \<100mg/dL. .
  • CPK, ALT and AST \< 1.5 x upper limit of normal at baseline.

You may not qualify if:

  • Women currently receiving cyclical hormones.
  • Treatment with hypolipidemic drugs during the last month.
  • Oral corticosteroids, NSAID, COX-1 inhibitors and other antiplatelet drugs.
  • Women with childbearing potential unless on safe contraception.
  • Psychiatric disease with defect in judgement.
  • Severe renal or hepatic diease.
  • Uncontrolled hypo- or hyperthyroidism.
  • Contraindication for ezetimibe or statin treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internal Medicine Department A ,Ziv Goverment Hospital

Safed, 13110, Israel

Location

Related Publications (13)

  • 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. doi: 10.7326/0003-4819-142-5-200503010-00012.

    PMID: 15738456BACKGROUND

  • Kamath S, Blann AD, Lip GY. Platelet activation: assessment and quantification. Eur Heart J. 2001 Sep;22(17):1561-71. doi: 10.1053/euhj.2000.2515. No abstract available.

    PMID: 11492985BACKGROUND

  • 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. doi: 10.1161/hs0102.102010.

    PMID: 11779889BACKGROUND

  • 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. doi: 10.1055/s-2007-995840.

    PMID: 9579642BACKGROUND

  • 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. doi: 10.1016/j.amjcard.2004.11.045.

    PMID: 15757620BACKGROUND

  • Reilly MP, Pratico 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. doi: 10.1161/01.cir.98.25.2822.

    PMID: 9860782BACKGROUND

  • Patrono C. Aspirin resistance: definition, mechanisms and clinical read-outs. J Thromb Haemost. 2003 Aug;1(8):1710-3. doi: 10.1046/j.1538-7836.2003.00284.x. No abstract available.

    PMID: 12911581BACKGROUND

  • Cipollone F, Ciabattoni G, Patrignani P, Pasquale M, Di Gregorio D, Bucciarelli T, Davi G, Cuccurullo F, Patrono C. Oxidant stress and aspirin-insensitive thromboxane biosynthesis in severe unstable angina. Circulation. 2000 Aug 29;102(9):1007-13. doi: 10.1161/01.cir.102.9.1007.

    PMID: 10961965BACKGROUND

  • Surya II, Akkerman JW. The influence of lipoproteins on blood platelets. Am Heart J. 1993 Jan;125(1):272-5. doi: 10.1016/0002-8703(93)90096-r. No abstract available.

    PMID: 8380241BACKGROUND

  • Ardlie NG, Selley ML, Simons LA. Platelet activation by oxidatively modified low density lipoproteins. Atherosclerosis. 1989 Apr;76(2-3):117-24. doi: 10.1016/0021-9150(89)90094-4.

    PMID: 2730708BACKGROUND

  • 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. doi: 10.1046/j.1365-2125.1997.00625.x.

    PMID: 9241100BACKGROUND

  • 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. doi: 10.1093/ajcp/31.4.305. No abstract available.

    PMID: 13637038BACKGROUND

  • LOWRY OH, ROSEBROUGH NJ, FARR AL, RANDALL RJ. Protein measurement with the Folin phenol reagent. J Biol Chem. 1951 Nov;193(1):265-75. No abstract available.

    PMID: 14907713BACKGROUND

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Osamah Hussein, MD

    Internal Medicine Department A, Ziv Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 25, 2007

First Posted

April 27, 2007

Study Start

July 1, 2005

Study Completion

January 1, 2007

Last Updated

February 20, 2013

Record last verified: 2013-02

Locations

IL(1)