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Ticagrelor Administered as Standard Tablet or Orodispersible Formulation

NCT03822377 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2021-09-08

Study results available
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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

Interventions

DRUG

Ticagrelor orodispersible tablets

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

DRUG

Ticagrelor standard tablets

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Azienda Ospedaliero Universitaria di Sassari

    lead OTHER

Principal Investigators

  • Guido Parodi, Professor · Cardiologia Clinica e Interventistica - AOU Sassari

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-27
Primary Completion
2020-08-31
Completion
2020-08-31
FDA Drug
Yes

Countries

  • Italy

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03822377 on ClinicalTrials.gov