Ticagrelor Administered as Standard Tablet or Orodispersible Formulation

NCT03822377 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: ESR-17-131742018-001790-25
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

ST Elevation Myocardial Infarction; NSTEMI - Non-ST Segment Elevation MI

Outcome Measures

Primary Outcomes (1)

• Evaluation of Platelet Inhibition

  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 Outcomes (3)

• Percent of Patients With Insufficient Antiaggregation

  1 hour

• Number of Participants With Residual Platelet Reactivity at Various Timepoints

  2, 4 and 6 hours

• Number of Participants With Clinically Relevant Bleeding Events

  30 days

Other Outcomes (2)

• Number of Participants With Morphine-ticagrelor Interaction

  6 hours

• Incidence of Adverse Events Occurring During Hospital Stay

  Until discharge from the hospital (usually up to 7 days)

Study Arms (2)

Ticagrelor orodispersible tablets

EXPERIMENTAL

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 standard tablets

ACTIVE COMPARATOR

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 standard tablets

Interventions

Ticagrelor orodispersible tablets DRUG

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

Ticagrelor orodispersible tablets

Ticagrelor standard tablets DRUG

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

Ticagrelor standard tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria di Sassari: lead
• AstraZeneca: collaborator

Study Sites (1)

Cardiologia Clinica e Interventistica - AOU Sassari

Sassari, 07100, Italy

Location

Related Publications (1)

• Parodi G, Talanas G, Mura E, Canonico ME, Siciliano R, Guarino S, Marini A, Dossi F, Franca P, Raccis M, Saba PS, Sanna GD. Orodispersible Ticagrelor in Acute Coronary Syndromes: The TASTER Study. J Am Coll Cardiol. 2021 Jul 20;78(3):292-294. doi: 10.1016/j.jacc.2021.05.015. No abstract available.

  PMID: 34266583 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Prof. Guido Parodi
• Organization: Cardiology Clinic, Sassari University Hospital, Sassari, Italy

parodiguido@gmail.com

0039

Study Officials

• Guido Parodi, Professor

  Cardiologia Clinica e Interventistica - AOU Sassari

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Site investigators performing platelet function tests will be blinded regarding patient randomization arm and the blood samples will be fully anonymized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 30, 2019
• Study Start: June 27, 2019
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: September 8, 2021
• Results First Posted: September 8, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)