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Trial record 44 of 1241 for:    ASPIRIN AND Platelet Aggregation

Pharmacological Study That Measures Omeprazole Effect on Aspirins Absorption in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01061034
Recruitment Status : Completed
First Posted : February 2, 2010
Results First Posted : February 2, 2010
Last Update Posted : February 2, 2010
Information provided by:
Assaf-Harofeh Medical Center

Brief Summary:

Aspirin is a weak acid that crosses the gastric and intestinal mucosa by passive diffusion while in its lipophilic nature.Omeprazole, a proton pump inhibitor, inhibits gastric acid secretion.

We assumed that omeprazole inhibits aspirin absorption, thus reducing its action on platelets.

healthy volunteers, with no known peptic disease or bleeding disorders will be enrolled.

All volunteers will receive 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole 20mg twice daily for 3 days and then 20mg once daily.

Blood levels of Aspirin will be determined by High performance liquid chromatography (HPLC), 0, 1, 2, 4, 6, 10, 24 hours after the administration of Aspirin alone on day 7 and Aspirin plus Omeprazole on day 21.

Platelet function tests will be determined by platelet-rich plasma aggregometry in response to Arachidonic acid (500mg/ml), Ristocetin (1.5mg/ml) and Adenosine 5'-diphosphate (20mM) on day 0 as baseline and on day 7 and 21 of the study.

Condition or disease Intervention/treatment Phase
Aspirin Blood Level Proton Pump Inhiditor Treatment Drug: aspirin and omeprazole Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Effect of Proton Pump Inhibitor (Omeprazole) on Acetosalisylic Acid Absorption.
Study Start Date : March 2007
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: aspirin and omeprazole
    aspirin 100 mg, once daily aspirin 100 mg and omeprazole 20 mg both once daily.

Primary Outcome Measures :
  1. Aspirin Level in Blood (Area Under the Curve) [ Time Frame: on day 7,on day 21 ]

    Aspirins pharmacokinetics: aspirin blood level determined by use of high performance liquid chromatography (HPLC) at baseline, 1, 2,4,6,10 and 24 hours after administration of aspirin on day 7 and on day 21.

    The area unther the time vs. concentration curve of the reccurent measurments(AUC) reflects bioavailability of aspirin.

Secondary Outcome Measures :
  1. Platelet Function Tests [ Time Frame: on day 0 as a baseline and on day 7 and 21 of the study. ]

    Platelet function tests were determined by optical whole blood aggregometry in response to arachidonic acid and adenosine diphosphate.

    the results reflects the percent of active platelets.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

-healthy volunteers

Exclusion Criteria:

  • pretreatment with aspirin
  • pretreatment with non steroidal anti inflamatory drugs
  • pretreatment with antacids
  • history of peptic ulcer disease
  • coagulation or aggregation disorder.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01061034

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Assaf Harofeh Medical Center
Zerifin, Israel
Sponsors and Collaborators
Assaf-Harofeh Medical Center
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Study Director: ahuva golik, prop. asaf-harofemedical center
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Responsible Party: dr. keren doenyas barak, internal medicine A asaf-harofeh medical center Identifier: NCT01061034    
Other Study ID Numbers: 180/07
First Posted: February 2, 2010    Key Record Dates
Results First Posted: February 2, 2010
Last Update Posted: February 2, 2010
Last Verified: November 2009
Keywords provided by Assaf-Harofeh Medical Center:
proton pump inhiditor
Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors