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Trial record 14 of 618 for:    ASPIRIN AND clopidogrel

A Study to Evaluate Platlet Aggregation of Clopidogrel, EC Aspirin 81 mg, EC Omeprazole 40 mg Compare to PA32540

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ClinicalTrials.gov Identifier: NCT01557335
Recruitment Status : Completed
First Posted : March 19, 2012
Last Update Posted : March 19, 2012
Sponsor:
Information provided by (Responsible Party):
POZEN

Tracking Information
First Submitted Date  ICMJE March 13, 2012
First Posted Date  ICMJE March 19, 2012
Last Update Posted Date March 19, 2012
Study Start Date  ICMJE November 2010
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
Evaluate adenosine diphosphate (ADP)-induced platelet aggregation [ Time Frame: 7 days ]
To evaluate adenosine diphosphate (ADP)-induced platelet aggregation following administration of clopidogrel, EC aspirin 81 mg and EC omeprazole 40 mg, all dosed concomitantly, and PA32540 and clopidogrel dosed separately. The endpoint measure is IPA (Individual Platelet Aggregation)at day 7 and PA0 is the platelet aggregation at baseline. The IPA will be analyzed using analyses of variance (ANOVA).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
Evaluate arachidonic acid (AA)-induced platelet aggregation [ Time Frame: 7 days ]
To evaluate arachidonic acid (AA)-induced platelet aggregation following administration of clopidogrel, EC aspirin 81 mg and EC omeprazole 40 mg, all dosed concomitantly, and PA32540 and clopidogrel dosed separately. The secondary endpoint is the IPA (Individual Platelet Aggregation) and will be analyzed using the same methodology as the primary endpoint.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Platlet Aggregation of Clopidogrel, EC Aspirin 81 mg, EC Omeprazole 40 mg Compare to PA32540
Official Title  ICMJE A Randomized, Open-Label, Cross-Over, Study to Evaluate the Inhibitory Effect of Clopidogrel, EC Aspirin 81 mg and EC Omeprazole 40 mg All Dosed Concomitantly and PA32540 and Clopidogrel Dosed Separately on Platelet Aggregation in Healthy Volunteers
Brief Summary This study is designed to provide data on platelet aggregation of PA32540 plus clopidogrel dosed separately compared to EC aspirin 81 mg plus EC omeprazole 40 mg plus clopidogrel dosed concomitantly.
Detailed Description

PA32540 is proposed for the secondary prevention of cardio- and cerebrovascular events in patients at risk for developing aspirin-associated gastric ulcers.

Aspirin 81 mg taken concomitantly with clopidogrel 75 mg as maintenance doses is standard of care in some patients with cardiovascular disease. The combination of aspirin and clopidogrel, however, significantly increases the risk for bleeding events. To mitigate upper gastrointestinal bleeding events, these patients would require the use of a proton pump inhibitor. For that reason, the reference arm in this study uses Prilosec® 40 mg as a comparator - the same proton pump inhibitor at the same dose level.

The primary objective is to evaluate adenosine diphosphate (ADP)-induced platelet aggregation following administration of clopidogrel, EC aspirin 81 mg and EC omeprazole 40 mg, all dosed concomitantly, and PA32540 and clopidogrel dosed separately

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Platelet Aggregation
Intervention  ICMJE
  • Drug: Plavix® and PA32540
    one Plavix® 300 mg loading dose in the PM of Day 1 one Plavix® 75 mg maintenance dose in the PM of Days 2-7 PA32540(delayed release aspirin 325 mg plus immediate release omeprazole 40 mg)
  • Drug: EC aspirin (Bayer®) ,EC omeprazole (Prilosec®) , Clopidogrel (Plavix®)
    One EC aspirin (Bayer®) 81 mg tablet plus one EC omeprazole (Prilosec®) 40 mg capsule plus one Clopidogrel (Plavix®) tablet of 300 mg (loading dose) all One EC aspirin (Bayer®) 81 mg tablet plus one EC omeprazole (Prilosec®) 40 mg capsule plus one Clopidogrel (Plavix®) tablet of 75 mg (maintenance dose) all taken concomitantly in the AM of Days 2-7
Study Arms  ICMJE
  • Experimental: Clopidogrel (Plavix®) and PA32540
    PA32540 and Clopidogrel (Plavix®) tablet, 10 hours post PA32540
    Intervention: Drug: Plavix® and PA32540
  • Active Comparator: EC aspirin, EC omeprazole, Clopidogrel
    Intervention: Drug: EC aspirin (Bayer®) ,EC omeprazole (Prilosec®) , Clopidogrel (Plavix®)
Publications * Gurbel PA, Bliden KP, Fort JG, Jeong YH, Shuldiner A, Chai S, Gesheff T, Antonino M, Gesheff M, Zhang Y, Tantry US. Spaced administration of PA32540 and clopidogrel results in greater platelet inhibition than synchronous administration of enteric-coated aspirin and enteric-coated omeprazole and clopidogrel. Am Heart J. 2013 Feb;165(2):176-82. doi: 10.1016/j.ahj.2012.07.032. Epub 2012 Dec 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2012)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or non-lactating, non-pregnant female subjects who are 40 years or older at the time of initial dosing

    --Physical status within normal limits for age and consistent with observations at Screening

  • Able to understand and comply with study procedures required and able and willing to provide written informed consent prior to any study procedures being performed

Exclusion Criteria:

  • History of hypersensitivity, allergy or intolerance to omeprazole or other proton-pump inhibitors (PPIs)
  • History of hypersensitivity, allergy or intolerance to aspirin or any NSAID and/or a history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps
  • History of hypersensitivity or intolerance to clopidogrel
  • History of hepatitis B or C, a positive test for hepatitis B surface antigen, hepatitis C antibody, a history of human immunodeficiency virus (HIV) infection or demonstration of HIV antibodies
  • History of malignancy, treated or untreated, within the past five years, with the exception of successfully treated basal cell or squamous cell carcinoma of -Evidence of uncontrolled, or unstable cardio- or cerebrovascular disorder, which in the Investigator's opinion, would endanger a subject if he/she were to participate in the study
  • Presence of an uncontrolled acute, or a chronic medical illness, e.g., GI disorder, diabetes, hypertension, thyroid disorder, bleeding disorder, infection, which in the Investigator's opinion would endanger a subject if he/she were to participate in the study or interfere with the objective of this study
  • Schizophrenia or bipolar disorder
  • GI disorder or surgery leading to impaired drug absorption
  • < 70% platelet aggregation at Screening
  • Donation of blood or plasma within 4 weeks of the study
  • PPI use or any enzyme inducing/inhibiting agents within 4 weeks prior to dosing
  • Taking any antiplatelet drug within 2 weeks of the screening visit or during the study, or more than two 325 mg doses of aspirin or more than 2 doses of any other NSAIDs within 14 days prior to the screening visit
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01557335
Other Study ID Numbers  ICMJE PA32540-111
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party POZEN
Study Sponsor  ICMJE POZEN
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lisa Zimmerman POZEN
PRS Account POZEN
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP