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Trial record 96 of 512 for:    ASPIRIN AND P2

Impact of Ticagrelor Re-load on Pharmacodynamic Profiles

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: NCT01731041
Recruitment Status : Completed
First Posted : November 21, 2012
Results First Posted : June 10, 2015
Last Update Posted : June 10, 2015
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE November 14, 2012
First Posted Date  ICMJE November 21, 2012
Results First Submitted Date  ICMJE May 6, 2015
Results First Posted Date  ICMJE June 10, 2015
Last Update Posted Date June 10, 2015
Study Start Date  ICMJE January 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
Platelet Reactivity Index (PRI) by Vasodilator-stimulated Phosphoprotein (VASP) [ Time Frame: 4 hours ]
The primary end-point of the study is the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) between baseline and 4-hour after dosing in each arm of treatment
Original Primary Outcome Measures  ICMJE
 (submitted: November 14, 2012)
platelet reactivity index (PRI) [ Time Frame: 4 hours ]
The primary end-point is the comparison in the platelet reactivity index (PRI) determined by whole blood vasodilator-stimulated phosphoprotein (VASP) between baseline and 4-hour after dosing in each arms of treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
P2Y12 Reaction Units (PRU) Determined by VerifyNow P2Y12 [ Time Frame: 4 hours ]
Secondary analysis included the differences of platelet reactivity expressed as P2Y12 reaction units (PRU) in each group using the VerifyNow P2Y12 system.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2012)
Platelet reactivity [ Time Frame: 4 hours ]
An exploratory analysis will be performed between the differences of platelet reactivity in each group using light transmittance aggregometry and point-of-care testing using the VerifyNow system.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Ticagrelor Re-load on Pharmacodynamic Profiles
Official Title  ICMJE Impact of Ticagrelor Re-load on Pharmacodynamic Profiles in Patients on Maintenance Ticagrelor Therapy
Brief Summary Platelets are parts of your blood that stick together to help form a clot. The stickier your platelets are, the greater your chance of having a heart attack. A clot in the wrong place can lead to a heart attack or stroke. Ticagrelor (Brilinta) keeps platelets from sticking together and it helps people from having a heart attack. The American College of Cardiology has recommended a combination of aspirin and Brilinta as one of the best treatments for the prevention of heart attacks, and death in patients who have had a heart attack or coronary stents. However, it is unknown if Brilinta may improve its work to keep platelets from sticking together giving a loading dose in patients already treated with Brilinta. A loading dose is a one-time increased dose of the same drug. The purpose of this study is to demonstrate whether the platelets of patients treated with Brilinta become less sticky when Brilinta is re-loaded.
Detailed Description A higher degree of platelet inhibition remains the goal of peri-interventional and long-term anti-thrombotic therapy in patients with coronary artery disease. Previous observations have shown that in patients on clopidogrel therapy undergoing percutanoues coronary intervention who get re-loaded with clopidogrel obtain enhanced platelet inhibition. Ticagrelor represents a new class of nonthienopyridine platelet inhibitors designed to address the limitations of current oral antiplatelet therapy, which has been recently approved for clinical use. However, to date it is unknown if greater inhibition of platelet aggregation can be achieved by adding a ticagrelor loading dose in patients already on maintenance ticagrelor therapy (90 mg twice daily). In addition, how to manage patients undergoing coronary interventions already on chronic ticagrelor therapy with regards to ticagrelor loading is an emerging clinical question which has yet to be explored. Therefore, understanding the pharmacodynamic implications of a ticagrelor re-load strategy in patients on already on chronic ticagrelor therapy is warranted. The scope of the present study is to evaluate the impact of ticagrelor re-load in patients on chronic ticagrelor therapy. A total of 60 patients will be randomized into one of the following two arms of treatment: 1) 90 mg of ticagrelor; 2) 180 mg of ticagrelor. Pharmacodynamic assessments will be performed at baseline, 1-hour and 4-hour after dosing administration. Comparison between baseline and 4-hour values in term of platelet P2Y12 reactivity index determined by whole blood vasodilator-stimulated phosphoprotein will be the primary end-point of the study. Secondary endpoints will include other pharmacodynamic measures.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Drug: Ticagrelor 180mg
    Patients will receive 180 mg of ticagrelor
    Other Name: Brilinta
  • Drug: Ticagrelor 90mg
    Patients will receive 90 mg of ticagrelor
    Other Name: Brilinta
Study Arms  ICMJE
  • Experimental: Ticagrelor 180mg
    Patients randomized to this arm will be administered 180 mg of ticagrelor (experimental arm, loading dose).
    Intervention: Drug: Ticagrelor 180mg
  • Active Comparator: Ticagrelor 90mg
    Patients randomized to this arm will be administered 90 mg dose of ticagrelor (active comparator, standard dose).
    Intervention: Drug: Ticagrelor 90mg
Publications * Cho JR, Rollini F, Franchi F, DeGroat C, Bhatti M, Dunn EC, Ferrante E, Muniz-Lozano A, Suryadevara S, Zenni MM, Guzman LA, Bass TA, Angiolillo DJ. Pharmacodynamic Effects of Ticagrelor Dosing Regimens in Patients on Maintenance Ticagrelor Therapy: Results From a Prospective, Randomized, Double-Blind Investigation. JACC Cardiovasc Interv. 2015 Jul;8(8):1075-1083. doi: 10.1016/j.jcin.2015.02.022. Epub 2015 Jun 24.

*   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: November 14, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with a clinical indication to be on ticagrelor therapy (90mg/bid)
  2. On treatment with ticagrelor 90mg twice daily for at least 14 days
  3. Age between 18 to 80 years
  4. On aspirin <100mg/day

Exclusion Criteria:

  1. History of intracranial bleeding
  2. Severe hepatic impairment (ALT >2.5 times the upper limit of normal)
  3. Active bleeding or propensity to bleed
  4. Recent antiplatelet treatment (< 14 days) with a glycoprotein IIb/IIIa antagonist

6. Platelet count <80x106/mL 7. Hemodynamic instability 8. Serum creatinine <30 mL/min 9. On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban) 10. Patients with sick sinus syndrome or II or III degree AV block without pacemaker protection 12. Drugs interfering CYP3A4 metabolism (to avoid interaction with Ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromicin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromizycin 13. Hemoglobin < 10g/dL 14. Pregnant females [women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study].

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT01731041
Other Study ID Numbers  ICMJE UFJ 2012-096
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: Dominick J Angiolillo, MD, PhD University of Florida
PRS Account University of Florida
Verification Date May 2015

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