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Trial record 92 of 359 for:    ASPIRIN AND clopidogrel AND Purinergic Antagonists

Antithrombotic Effects of Ticagrelor Versus Clopidogrel

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.
 
ClinicalTrials.gov Identifier: NCT01642238
Recruitment Status : Completed
First Posted : July 17, 2012
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Juan J Badimon, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE July 13, 2012
First Posted Date  ICMJE July 17, 2012
Results First Submitted Date  ICMJE August 14, 2014
Results First Posted Date  ICMJE July 11, 2016
Last Update Posted Date July 11, 2016
Study Start Date  ICMJE July 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2016)
  • Platelet-thrombus Formation in an ex Vivo Model of Thrombosis [ Time Frame: Pre-treatment baseline and 1 hour ]
    Change in thrombus size at 1 hour as compared to Pre-treatment baseline, where a positive change represents a decrease in thrombus size.
  • Platelet-thrombus Formation in an ex Vivo Model of Thrombosis [ Time Frame: Pre-treatment baseline and 24 hrs post treatment ]
    Change in thrombus size at 24 hours as compared to Pre-treatment baseline, where a positive change represents a decrease in thrombus size.
Original Primary Outcome Measures  ICMJE
 (submitted: July 13, 2012)
  • Platelet-thrombus Formation in an ex Vivo Model of Thrombosis [ Time Frame: Pre-treatment baseline ]
  • Platelet-thrombus formation in an ex vivo model of thrombosis [ Time Frame: 1 hr post treatment ]
  • Platelet-thrombus Formation in an ex Vivo Model of Thrombosis [ Time Frame: 24 hrs post treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2016)
  • Platelet Reactivity [ Time Frame: Pre-treatment baseline ]
    Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition
  • Platelet Reactivity [ Time Frame: 1 hr post-treatment ]
    Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition
  • Platelet Reactivity [ Time Frame: 24-hours post-treatment ]
    Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition
  • Blood Thrombogenicity [ Time Frame: Pre-treatment baseline ]
    Coagulation times, assessed using the ROTEM thromboelastometry
  • Blood Thrombogenicity [ Time Frame: 1 hr post-treatment ]
    Coagulation times, assessed using the ROTEM thromboelastometry
  • Blood Thrombogenicity [ Time Frame: 24-hours post-treatment ]
    Coagulation times, assessed using the ROTEM thromboelastometry
Original Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2012)
  • Platelet reactivity by Accumetrics VerifyNow and Multiplate Analyzer [ Time Frame: Pre-treatment baseline ]
  • Platelet reactivity by Accumetrics VerifyNow and Multiplate Analyzer [ Time Frame: 1 hr post-treatment ]
  • Platelet reactivity by Accumetrics VerifyNow and Multiplate Analyzer [ Time Frame: 24-hours post-treatment ]
  • Blood thrombogenecity by Thromboelastography [ Time Frame: Pre-treatment baseline ]
  • Blood thrombogenecity by Thromboelastography [ Time Frame: 1 hr post-treatment ]
  • Blood thrombogenecity by Thromboelastography [ Time Frame: 24-hours post-treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antithrombotic Effects of Ticagrelor Versus Clopidogrel
Official Title  ICMJE Randomized, Crossover Study of the Antithrombotic Effects of Ticagrelor Plus Aspirin Versus Clopidogrel Plus Aspirin When Administered With Bivalirudin
Brief Summary The purpose of this study is to determine whether treatment with ticagrelor (plus aspirin and bivalirudin) is more effective than treatment with clopidogrel (plus aspirin and bivalirudin).
Detailed Description

The HORIZONS-AMI Trial compared the effectiveness of heparin plus a glycoprotein IIb/IIIa inhibitor (GPI) versus bivalirudin in acute myocardial infarction (AMI) patients undergoing stent deployment 1. Overall the data showed benefits associated with the bivalirudin treatment with lower rates of all-cause mortality, cardiac mortality, re-infarction and non-CABG related major bleeding; However, the data seems to indicate a non-significant increase in acute stent thrombosis in the bivalirudin group. This observation seems to suggest the potential benefits of adding an antiplatelet agent to bivalirudin. A study by Dangas G et al found that in the HORIZONS-AMI patients, the group receiving 600 mg loading-dose of clopidogrel had significantly lower 30-day unadjusted rates of mortality, reinfarction and stent thrombosis than the 300 mg loading-dose group, without increase in bleeding rate. Furthermore, even though the benefits of bivalirudin were independent of the clopidogrel loading dose; the 600mg LD was associated with more benefits with both anticoagulation regimens. Similar observations have been reported in the ARMYDA-6 MI study.

It is our hypothesis that using ticagrelor instead of clopidogrel, given its more potent and faster activity, would have greater antithrombotic activity and therefore may reduce the rate of acute stent thrombosis when administered in combination with bivalirudin + ASA in AMI patients. To investigate this hypothesis, we will compare the antithrombotic effects of ticagrelor with clopidogrel, when administered in combination with ASA and bivalirudin, in healthy human volunteers using a cross-over study design. The antithrombotic activity will be assessed pre-treatment and 2-hours and 24-hours post treatment, using methodologies including Badimon Perfusion chamber, VerifyNow P2Y12 assay, platelet aggregation with Multiplate Analyzer and Thromboelastography.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Coronary Syndrome
Intervention  ICMJE
  • Drug: Ticagrelor + ASA + Bivalirudin
    Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
    Other Names:
    • Brilinta (ticagrelor
    • Aspirin (ASA)
    • Angiomax (bivalirudin)
  • Drug: Clopidogrel + ASA + Bivalirudin
    Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
    Other Names:
    • Plavix (clopidogrel)
    • Aspirin (ASA)
    • Angiomax (bivalirudin)
Study Arms  ICMJE
  • Experimental: Ticagrelor + ASA + Bivalirudin
    Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
    Intervention: Drug: Ticagrelor + ASA + Bivalirudin
  • Active Comparator: Clopidogrel + ASA + Bivalirudin
    Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
    Intervention: Drug: Clopidogrel + ASA + Bivalirudin
Publications * Zafar MU, Vorchheimer DA, Tewar MP, Giannarelli C, Crippa M, Sartori S, Rodriguez D, Baber U, Mehran R, Badimon JJ. Ticagrelor reduces thrombus formation more than clopidogrel, even when co-administered with bivalirudin. Thromb Haemost. 2014 Nov;112(5):1069-70. doi: 10.1160/TH14-03-0269. Epub 2014 Aug 7.

*   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: July 13, 2012)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female volunteers between 18 and 65 years old.
  • Body mass index (BMI) 18 - 30 kg/m2 inclusive.
  • Healthy as assessed by a detailed medical history and physical examination.
  • Laboratory est results within the normal range.
  • Ability to provide signed informed consent.

Exclusion Criteria:

  • History of clinically relevant disease, bleeding, acute infectious disease or signs of acute illness.
  • Allergy or hypersensitivity to aspirin or thienopyridines, or atopy diagnosed by a physician.
  • Use of medication within one month prior to study drug administration.
  • History of drug abuse or alcohol consumption >20 g/day.
  • Inability to abstain from intensive muscular effort or sport competition.
  • Loss of >400 mL blood or blood donation within 3 months.
  • Positive serology for hepatitis B (HBs Ag) or hepatitis C.
  • Conditions associated with hemorrhagic risk.
  • Positive pregnancy test.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (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 NCT01642238
Other Study ID Numbers  ICMJE GCO 12-0732
ISSBRIL0067
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juan J Badimon, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Juan J Badimon
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: Juan J Badimon, PhD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date June 2016

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