- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03822377
Ticagrelor Administered as Standard Tablet or Orodispersible Formulation (TASTER)
Ticagrelor Administered as Standard Tablet or orodispersiblE foRmulation
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Sassari, Italy, 07100
- Cardiologia Clinica e Interventistica - AOU Sassari
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- Informed, written consent
- Male or female patients, aged ≥ 18 years old
Exclusion Criteria:
- Age < 18 years
- Active bleeding; bleeding diathesis; coagulopathy
- History of gastrointestinal or genitourinary bleeding <2 months
- Major surgery in the last 6 weeks
- History of intracranial bleeding or structural abnormalities
- Suspected aortic dissection
- Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux.
- Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers, CYP3A with narrow therapeutic window
- Known relevant hematological deviations: Hb <10 g/dl, Thromb. <100x10^9/l
- Use of warfarin or new oral anticoagulant derivatives within the last 7 days
- Known severe liver disease, severe renal failure
- Allergy or hypersensitivity to ticagrelor or any of the excipients.
- Pregnancy or lactation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ticagrelor orodispersible tablets
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. |
Ticagrelor loading dose (180 mg) given as two orodispersible tablets (each of 90 mg), to be dispersed in saliva.
|
Active Comparator: Ticagrelor standard tablets
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. |
Ticagrelor loading dose (180 mg) given as two standard coated tablets (each of 90 mg) to be swallowed with water.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. The VerifyNow PRU Test is designed to measure P2Y12 receptor blockade. Results of the PRU Tests are reported as P2Y12 Reaction Units (PRU). PRU measures the extent of platelet aggregation in the presence of a P2Y12 inhibitor. Lower PRU levels are associated with expected antiplatelet effect. |
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 hour
|
Number of Participants With 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 to assess antiplatelet effect of P2Y12 inhibitors
|
2, 4 and 6 hours
|
Number of Participants With 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)
|
30 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Morphine-ticagrelor Interaction
Time Frame: 6 hours
|
Potential morphine-ticagrelor interaction will be assessed by stratified randomization according to morphine use
|
6 hours
|
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
|
Until discharge from the hospital (usually up to 7 days)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Guido Parodi, Professor, Cardiologia Clinica e Interventistica - AOU Sassari
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Myocardial Infarction
- Infarction
- ST Elevation Myocardial Infarction
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Ticagrelor
Other Study ID Numbers
- ESR-17-13174
- 2018-001790-25 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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