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A Single Center Study to Evaluate Ticagrelor Mechanism of Action in Inhibiting Juvenile Platelet ADP Response

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: NCT03027934
Recruitment Status : Unknown
Verified July 2017 by CirQuest Labs, LLC.
Recruitment status was:  Not yet recruiting
First Posted : January 23, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
CirQuest Labs, LLC

Brief Summary:
The overall objective of this study is to assess P2Y12 inhibition ex vivo in blood samples obtained from diabetic subjects who will be administered one of the two P2Y12 antagonists in a cross-over design.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Ticagrelor Drug: Prasugrel Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Single Center, Randomized, Open Label, Crossover Study With Ticagrelor and Prasugrel to Evaluate Ticagrelor Mechanism of Action in Inhibiting Juvenile Platelet ADP Response
Estimated Study Start Date : August 28, 2017
Estimated Primary Completion Date : October 31, 2017
Estimated Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1 Drug: Ticagrelor
Ticagrelor, 90mg twice daily
Other Name: Brilinta

Drug: Prasugrel
Prasurgrel, 10mg once daily
Other Name: Effient

Active Comparator: Group 2 Drug: Ticagrelor
Ticagrelor, 90mg twice daily
Other Name: Brilinta

Drug: Prasugrel
Prasurgrel, 10mg once daily
Other Name: Effient




Primary Outcome Measures :
  1. Aggregation Response [ Time Frame: 23 hr Day 5 ]
    Comparison of aggregation response using ADP in subjects receiving prasurgrel versus ticagrelor


Secondary Outcome Measures :
  1. Reticulated Platelet Reactivity Index (PRI) [ Time Frame: 23 hr Day 5 ]
    Comparison of PRI as measured by VASP in subjects receiving ticagrelor versus subjects receiving prasugrel



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. Male or female aged 18 to 70 years, inclusive.
  3. Documented current medical history of diabetes controlled by either medication or diet and/or exercise.
  4. Women must have a negative urine pregnancy test.

Exclusion Criteria:

  1. Pregnant or lactating females, or females of child-bearing potential (i.e., those who are not chemically or surgically sterilized or who are not post-menopause) or those who are not willing to use a medically accepted method of contraception that is considered reliable in the judgement of the investigator throughout the duration of the study or females who have a positive pregnancy test at screening.
  2. Weight of less than 135 lbs.
  3. Currently prescribed and taking clopidogrel (generic or Plavix), ticagrelor (Brilinta) or prasugrel (Effient) or have taken within the past 10 days.
  4. Current medications:

    1. PAR-1 antagonist (vorapaxar/Zontivity) or within the last month.
    2. Phosphodiesterase inhibitors such as cilostazol (Pletal).
    3. Glycoprotein IIb/IIIa inhibitors or within the last ten days (Integrilin, Aggrastat, ReoPro).
    4. Adenosine reuptake inhibitors such as dipyridamole (Aggrenox, Persantine)
    5. Coumadin.
    6. Heparin including low molecular weight heparin.
    7. Factor Xa inhibitors (e.g., enoxaparin, rivaroxaban, apixaban, and edoxaban).
    8. Direct thrombin inhibitors (e.g., hirudin, bivalirudin, dabigatran.
    9. Concomitant therapy with strong CYP3A inhibitors, such as atanazavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazadone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconizole,
    10. Concomitant therapy with potent CYP3A inducers, such as rifampin, phenytoin, carbamazepine, and phenobarbital.
  5. Increased bleeding risk including:

    1. Recent (within 30 days) GI bleeding
    2. Active pathological bleeding
    3. Any history of intracranial, intraocular, retroperitoneal, or spinal bleeding
    4. Prior history of transient ischemic attack or stroke
    5. Recent (within 3 months) major trauma
    6. Sustained uncontrolled hypertension (systolic blood pressure [SBP] > 180mmHg or diastolic blood pressure [DBP] > 100mmHg
    7. History of hemorrhagic disorders that can increase the risk of bleeding (e.g., hemophilia, von Willebrand's disease)
    8. Patients that have used within 30 days of screening, any oral or parenteral anti-thrombotic agent.
    9. Platelet count less than 100,000 mm3 or hemoglobin < 10g/dL
  6. Contraindication or other reason that ticagrelor or prasugrel should not be administered (e.g., known hypersensitivity to medication or any medication component)
  7. A history of alcohol and/or substance abuse that could interfere with conduct of the trial.
  8. Known active or recurrent hepatic disorder (including cirrhosis, hepatitis B and hepatitis C, or confirmed (ALT/AST) levels > 3 times ULN or total bilirubin > 2 times ULN at screening.
  9. Scheduled for revascularization (e.g., PCI, CABG) during the study period.
  10. Any Acute Coronary Syndrome (ACS) event within the past 6 months.
  11. Participation in another investigational drug or device study within 30 days of dosing.
  12. Any acute or chronic unstable condition in the past 30 days or other condition which, in the opinion of the investigator, may either put the subject at risk or influence the result of the study (e.g., active cancer, risk for non-compliance, risk for lost to follow-up).

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 ClinicalTrials.gov identifier (NCT number): NCT03027934


Contacts
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Contact: Edward Hord 901-866-1705 edwardhord@cirquestlabs.com
Contact: Laura Yacoubian 901-569-1432 lhyacoubian@cirquestlabs.com

Sponsors and Collaborators
CirQuest Labs, LLC
Investigators
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Principal Investigator: Jayaprakash Kotha CirQuest Labs

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Responsible Party: CirQuest Labs, LLC
ClinicalTrials.gov Identifier: NCT03027934    
Other Study ID Numbers: ESR-14-10619
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Ticagrelor
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs