Ticagrelor Administered as Standard Tablet or Orodispersible Formulation (TASTER)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03822377|
Recruitment Status : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|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 Description:||Site investigators performing platelet function tests will be blinded regarding patient randomization arm and the blood samples will be fully anonymized.|
|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|
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.
- 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.
- 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.
- 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
- 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)
- Morphine-ticagrelor interaction [ Time Frame: 6 hours ]Potential morphine-ticagrelor interaction will be assessed by stratified randomization according to morphine use
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822377
|Contact: Guido Parodi, Professor||0792061521 ext +email@example.com|
|Contact: Giuseppe Nusdeo, Doctor||3480593221 ext +firstname.lastname@example.org|
|Cardiologia Clinica e Interventistica - AOU Sassari||Not yet recruiting|
|Sassari, Italy, 07100|
|Contact: Guido Parodi, Professor 3386949780 ext +39 email@example.com|
|Contact: Giuseppe Nusdeo, Doctor 3480593221 firstname.lastname@example.org|
|Principal Investigator:||Guido Parodi, Professor||Cardiologia Clinica e Interventistica - AOU Sassari|