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Ticagrelor Administered as Standard Tablet or Orodispersible Formulation (TASTER)

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ClinicalTrials.gov Identifier: NCT03822377
Recruitment Status : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Prof. Guido Parodi, Azienda Ospedaliero Universitaria di Sassari

Brief Summary:
Randomized clinical study evaluating superiority in platelet inhibition after administration of Ticagrelor 180 mg loading dose as an orodispersible formulation versus traditional coated tablets in patients admitted for ST elevation myocardial infarction or very high-risk non-ST elevation myocardial infarction.

Condition or disease Intervention/treatment Phase
ST Elevation Myocardial Infarction NSTEMI - Non-ST Segment Elevation MI Drug: Ticagrelor orodispersible tablets Drug: Ticagrelor pills Phase 3

Detailed Description:
Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion strategy for patients with acute ST-segment elevation myocardial infarction (STEMI). Additional antithrombotic therapy prior or during intervention plays an important role in the short- and long-term outcomes after PPCI. Oral antiplatelet therapy including a platelet P2Y12 receptor inhibitors is a cornerstone of antithrombotic treatment in patients with acute coronary syndromes. Prasugrel and Ticagrelor have been shown to be superior to Clopidogrel in patients with STEMI in reduction of ischemic complication without any increase in the bleeding risk and with a significant reduction in the stent thrombosis rate. Nevertheless, in STEMI patients, pharmacodynamic studies showed prasugrel and ticagrelor oral loading dose (LD) provided a suboptimal platelet inhibition in the first hours after LD, and at least 4 hours are required to achieve and effective platelet aggregation inhibition in the majority of patients, in part due to slowed gut motility caused by morphine use. Orodispersible tablet (ODT) is a different tablet formulation that disperses upon contact with the moist mucosal surfaces of the oral cavity and quickly release its components before swallowing; thus local drug dissolution and absorption as well as onset of clinical effect can be obtained conveniently easily and quickly by bypassing gastrointestinal tract. Recently, Ticagrelor 90 mg ODT has become available and bioequivalence studies on healthy volunteers documented its effectiveness with consequent approval by European Medicine Agency of this formulation which is currently available on the market. Thus, the aim of the present study is to evaluate the superiority in platelet inhibition with 180 mg Ticagrelor loading dose (LD) administered as ODTs as compared with standard formulation, among patients with STEMI or very high-risk NSTEMI undergoing immediate PCI. Primary objective consists in evaluating platelet reactivity 1 hour after Ticagrelor loading dose by VerifyNow test.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparison of platelet inhibition at different timepoints between 65 patients in the treatment arm (receiving orodispersible formulation of ticagrelor loading dose) versus 65 patients in the control arm (receiving standard coated formulation of ticagrelor loading dose). Randomization will be further stratified according to morphine use.
Masking: Single (Investigator)
Masking Description: Site investigators performing platelet function tests will be blinded regarding patient randomization arm and the blood samples will be fully anonymized.
Primary Purpose: Treatment
Official Title: Ticagrelor Administered as Standard Tablet or orodispersiblE foRmulation
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

Arm Intervention/treatment
Experimental: Experimental arm

STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as orodispersible tablets.

Intervention: administration of Ticagrelor 180 mg loading dose as orodispersible tablets.

Drug: Ticagrelor orodispersible tablets
Ticagrelor loading dose (180 mg) given as two orodispersible tablets (each of 90 mg), to be dispersed in saliva.

Active Comparator: Control arm

STEMI or very high-risk NSTEMI patients undergoing primary PCI and receiving Ticagrelor 180 mg loading dose as standard coated tablets.

Intervention: administration of Ticagrelor 180 mg loading dose as standard coated pills.

Drug: Ticagrelor pills
Ticagrelor loading dose (180 mg) given as two standard coated tablets (each of 90 mg) to be swallowed with water.




Primary Outcome Measures :
  1. Evaluation of platelet inhibition [ Time Frame: 1 hour ]
    Platelet reactivity will be measured by VerifyNow test 1 hour after Ticagrelor loading dose (LD) administered as orodispersible tablets as compared with standard formulation in 130 patients with STEMI or very high-risk NSTEMI undergoing immediate PCI.


Secondary Outcome Measures :
  1. Percent of patients with insufficient antiaggregation [ Time Frame: 1 hour ]
    The percent of patients with a high residual platelet reactivity (PRU > 208 by VerifyNow test), thus not adequately antiaggregated, 1 hour after Ticagrelor LD.

  2. Residual platelet reactivity at various timepoints [ Time Frame: 2, 4 and 6 hours ]
    Residual platelet reactivity (PRU) at 2, 4 and 6 hours measured by VerifyNow test

  3. Incidence of clinically relevant bleeding events [ Time Frame: 30 days ]
    Actionable bleeding events across the two different regimens of Ticagrelor administration, requiring diagnostic studies, hospitalization, or treatment by a health care professional (BARC type 2 or higher)


Other Outcome Measures:
  1. Morphine-ticagrelor interaction [ Time Frame: 6 hours ]
    Potential morphine-ticagrelor interaction will be assessed by stratified randomization according to morphine use

  2. Incidence of adverse events occurring during hospital stay [ Time Frame: Until discharge from the hospital (usually up to 7 days) ]
    Combined ticagrelor administration-related adverse events defined as in-hospital ≥2 BARC bleedings, dyspnea, ventricular pauses, allergic reactions, or vomit



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

Inclusion Criteria:

  1. Patients presenting within 12 hours from the onset of symptoms with STEMI or very high-risk NSTEMI referred for immediate (< 2 hours) angiography. Very high-risk NSTEMI patients include patients with haemodynamic instability or cardiogenic shock, heart failure, life-threatening arrhythmias or resuscitated cardiac arrest, intermittent ST-segment elevation, or ongoing chest pain.
  2. Informed, written consent
  3. Male or female patients, aged ≥ 18 years old

Exclusion Criteria:

  1. Age < 18 years
  2. Active bleeding; bleeding diathesis; coagulopathy
  3. History of gastrointestinal or genitourinary bleeding <2 months
  4. Major surgery in the last 6 weeks
  5. History of intracranial bleeding or structural abnormalities
  6. Suspected aortic dissection
  7. Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux.
  8. Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers, CYP3A with narrow therapeutic window
  9. Known relevant hematological deviations: Hb <10 g/dl, Thromb. <100x10^9/l
  10. Use of warfarin or new oral anticoagulant derivatives within the last 7 days
  11. Known severe liver disease, severe renal failure
  12. Allergy or hypersensitivity to ticagrelor or any of the excipients.
  13. Pregnancy or lactation

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): NCT03822377


Contacts
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Contact: Guido Parodi, Professor 0792061521 ext +39 gparodi@uniss.it
Contact: Giuseppe Nusdeo, Doctor 3480593221 ext +39 gnusdeo@uniss.it

Locations
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Italy
Cardiologia Clinica e Interventistica - AOU Sassari Not yet recruiting
Sassari, Italy, 07100
Contact: Guido Parodi, Professor    3386949780 ext +39    gparodi@uniss.it   
Contact: Giuseppe Nusdeo, Doctor    3480593221    gnusdeo@uniss.it   
Sponsors and Collaborators
Azienda Ospedaliero Universitaria di Sassari
AstraZeneca
Investigators
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Principal Investigator: Guido Parodi, Professor Cardiologia Clinica e Interventistica - AOU Sassari

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Responsible Party: Prof. Guido Parodi, Professor, Azienda Ospedaliero Universitaria di Sassari
ClinicalTrials.gov Identifier: NCT03822377     History of Changes
Other Study ID Numbers: ESR-17-13174
2018-001790-25 ( EudraCT Number )
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
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

Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Myocardial Ischemia
Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
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